Prospective randomized two-Arm controlled study to determine the efficacy of a specific intervention to improve long-term adherence to highly active antiretroviral therapy. A cluster randomised trial to evaluate a nutrition training programme. Use of a time series design to test effectiveness of a theory-based intervention targeting adherence of health professionals to a clinical guideline. Assessment of two culturally competent diabetes education methods: individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes. Evaluation of an instructional program for improving medication compliance for chronically mentally ill outpatients. Multidisciplinary HIV adherence intervention: a randomized study. Evaluation of family health education to build social support for long-term control of high blood pressure. A randomized controlled trial of a new behavioral home-based nutrition education program, "Eat Well with CF," in adults with cystic fibrosis. Enhancing commitment improves adherence to a medical regimen. Evaluation of a PDA-based dietary assessment and intervention program: a randomized controlled trial. A video game improves behavioral outcomes in adolescents and young adults with cancer: a randomized trial. Program to enhance health literacy and treatment adherence in low-income HIV-infected Latino men and women. Adherence to a Very Low Fat Diet for Cardiac Rehabilitation Patients. A test of interventions to increase adherence to hypertensive medical regimens. Long-term effects of interventions for weight loss using food provision and monetary incentives. Brief, computer-assisted diabetes dietary self-management counseling: effects on behavior, physiologic outcomes, and quality of life. Home visits to improve adherence to highly active antiretroviral therapy: a randomized controlled trial. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Motivational interviewing and cognitive-behavioral intervention to improve HIV medication adherence among hazardous drinkers: a randomized controlled trial. Effects of formal education for patients with inflammatory bowel disease: a randomized controlled trial. Use of multisystemic therapy to improve regimen adherence among adolescents with type 1 diabetes in chronic poor metabolic control: a randomized controlled trial. Efficacy of an educational and counseling intervention on adherence to highly active antiretroviral therapy: French prospective controlled study. Couple-focused support to improve HIV medication adherence: a randomized controlled trial. Computerized dietary assessments compare well with interviewer administered diet histories for patients with type 2 diabetes mellitus in the primary healthcare setting. Promoting adherence: effects of theory-based asthma education. Further validation and reliability testing of the Trust in Physician Scale. The Stanford Trust Study Physicians. Preliminary trial of the effect of general practice based nutritional advice. One-year results from a brief, computer-assisted intervention to decrease consumption of fat and increase consumption of fruits and vegetables. Using motivational interviewing to promote adherence to antiretroviral medications: a pilot study. Brief behavioral self-regulation counseling for HIV treatment adherence delivered by cell phone: an initial test of concept trial.
Nearly perfect compliance seems to be indispensable to obtain the maximum benefit from highly active antiretroviral therapy (HAART). Interventions to ensure a high level of adherence during a relatively long-term period of therapy are necessary.
                This is a prospective, randomized, two-arm controlled study including patients starting their first-or second-line HAART who were randomized to receive psychoeducative intervention to implement adherence (experimental group [EG]) or a usual medical follow-up (control group [CG]). We aimed to study the efficacy of a psychoeducative intervention to ensure long-term adherence to HAART, its relation with the virologic efficacy of treatment, and to determine the variables related to long-term adherence. Visits were made at weeks 0, 4, 24, and 48 for data collection. Self-reported adherence was registered at each visit and its veracity was tested by randomized blood analyses performed without previous warning to 40% of patients. Appropriate adherence was defined as the consumption of >/=95% of medication prescribed. Statistical analyses were performed both by the as treated (AT) and the intention to treat missing = failure (ITT) methods.
                In all, 116 patients were included. At week 48, 94% of patients in the EG versus 69% controls achieved adherence >/=95% (p =.008); 89% of patients in the EG versus 66% controls had HIV-1 RNA levels <400 copies/ml (p =.026). Overall, 85% of patients with adherence >/=95% but only 45% of those with adherence <95% had viral load (VL) <400 copies/ml (p =. 008). In multivariate analysis, variables significantly related to adherence were having received a psychoeducative intervention (odds ratio [OR], 6.58; p =.04), poor effort to take medication (OR, 5.38; p =.03), and high self-perceived capacity to follow the regimen (OR, 13.76; p =.04). Self-reported adherence and drug plasma levels coincided in 93% of cases. However, differences in adherence did not reach statistical significance in the ITT analysis although a clear tendency toward benefit was observed in EG.
                Specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherence as well as high levels of viral suppression. There is a clear relation between high adherence levels and virologic success. Assessment of certain specific variables related to adherence may be helpful to monitor patient's compliance in the clinical setting. The need for training to equip primary care staff with the knowledge and skills to provide dietary advice to the public has been acknowledged. Little is known about the effectiveness of such training at improving the dietary counselling skills of multidisciplinary practice teams.
                To evaluate the effectiveness of a nutrition training programme, delivered to primary care teams by a dietitian.
                A paired-cluster randomised trial.
                Twelve general practices in Sunderland, in the United Kingdom.
                A nutrition training programme, aimed at improving the quality of dietary consultations, was developed and delivered to six primary care teams by a dietitian. Main outcome measures were patients' recall of seven key consulting behaviours. Data were collected from patients in intervention and control practices, pre- and post-intervention. Change in knowledge and attitude of practitioners was also measured.
                All 12 practices completed the trial. Data were collected from 251 patients pre-intervention and 228 patients post-intervention. Of the seven consulting behaviours targeted in the training, only the proportion of consultations where written information (diet sheets) was provided to patients was significantly higher (13% higher, 95% confidence interval [CI = 4 to 21, P = 0.004) in the intervention practices post-training. Some evidence of improved practitioner knowledge and attitude was detected.
                This evaluation of a nutrition training intervention detected only a limited impact on the behaviour, knowledge, and attitudes of primary care practitioners in dietary consultations. The aim of this study was to test the effectiveness of a theory of planned behaviour intervention to increase adherence of community mental health professionals to a national suicide prevention guideline.
                Routinely collected audit adherence data from an intervention and control site were collected and analysed using time series analysis to test whether the intervention significantly increased adherence. The effects of a local and national event on adherence were also examined.
                A Theory of Planned Behaviour (TPB) questionnaire, developed from interview findings, was administered to the health professionals. Subjective norms were found to be the most significant predictor of intention to adhere to the guideline, and were targeted with an interactive educational intervention. Time series analysis applied to routinely collected audit adherence data was used to test intervention effectiveness.
                The TPB accounted for 58% of the variance in intention to adhere, with subjective norms the only significant predictor. The intervention did not significantly increase adherence; however, the national and local events were found to have significantly increased adherence.
                The TPB was a useful framework for exploring barriers to adherence; however, this did not translate into an effective intervention. Future research should seek collaboration with local experts, and use this information in combination with the TPB, to develop interventions. Collaborative research with experts in pedagogy may also help to develop more effective interventions, particularly education-based interventions that require adult learning. To examine the impact of two culturally competent diabetes education methods, individual counselling and individual counselling in conjunction with group education, on nutrition adherence and glycemic control in Portuguese Canadian adults with type 2 diabetes over a three-month period.
                The Diabetes Education Centre is located in the urban multicultural city of Toronto, Ontario, Canada. We used a three-month randomized controlled trial design. Eligible Portuguese-speaking adults with type 2 diabetes were randomly assigned to receive either diabetes education counselling only (control group) or counselling in conjunction with group education (intervention group). Of the 61 patients who completed the study, 36 were in the counselling only and 25 in the counselling with group education intervention. We used a per-protocol analysis to examine the efficacy of the two educational approaches on nutrition adherence and glycemic control; paired t-tests to compare results within groups and analysis of covariance (ACOVA) to compare outcomes between groups adjusting for baseline measures. The Theory of Planned Behaviour was used to describe the behavioural mechanisms that influenced nutrition adherence.
                Attitudes, subjective norms, perceived behaviour control, and intentions towards nutrition adherence, self-reported nutrition adherence and glycemic control significantly improved in both groups, over the three-month study period. Yet, those receiving individual counselling with group education showed greater improvement in all measures with the exception of glycemic control, where no significant difference was found between the two groups at three months.
                Our study findings provide preliminary evidence that culturally competent group education in conjunction with individual counselling may be more efficacious in shaping eating behaviours than individual counselling alone for Canadian Portuguese adults with type 2 diabetes. However, larger longitudinal studies are needed to determine the most efficacious education method to sustain long-term nutrition adherence and glycemic control. Outpatient medication adherence is a major problem, especially for patients repeatedly hospitalized for psychiatric disorders. This study included 39 such patients who were receiving case management services from a community mental health center. Patients were matched and randomly assigned to receive in a single session either (1) information regarding medication and its benefits, (2) guidelines for assuring adherence which encompassed all phases related to pill-taking including filling prescriptions, use of a pill container, transportation, self-reminders, doctor's appointments and so forth, or (3) the same guidelines as (2) above but given in the presence of a family member who was enlisted in support. The results showed that adherence increased to about 94% after the guidelines were given for both the individual and family guideline procedure, whereas adherence remained unchanged at 73% after the medication information procedure. These results suggest a practical means for assuring a high level of medication adherence for patients with psychiatric disorders. Maintaining greater than 95% adherence to antiretroviral medication is necessary in order to have the greatest therapeutic impact on HIV infection. Furthermore, evidence suggests that adherence rates of between 70% and 89% are significantly associated with viral rebound and the development of drug resistance. Adherence rates at and above the 95% level are difficult for patients to achieve and maintain. Our aim was to determine if an adherence intervention could improve adherence among patients attending an ambulatory care clinic at a large public hospital. The intervention was delivered by a multidisciplinary team of health care professionals and consisted of education coupled with the provision of devices designed to assist patient memory and adherence. A crucial component of the intervention consisted of the identification of patient specific barriers to adherence and the development of strategies to circumvent these problems. Adherence was assessed using patient self-report over the past 4, 7, and 28 days and by calculation of the Morisky score. The study was conducted as a randomised controlled trial using the stepped wedge design with a total of 68 subjects randomised to receive the intervention over a 20-week period. Adherence before and after the intervention formed the analysis. There was a significant decrease in the number of missed doses over the past 4 (1.9 to 1.0, p < 0.001), 7 (3.0 to 1.8, p < 0.001) and 28 (7.4 to 4.2, p < 0.001) days and a decrease in the Morisky score, indicating an improvement in medication taking behaviour (1.3 to 0.5 p < 0.001). Sustaining patient motivation for long-term adherence to drug therapies remains a substantial problem for physicians, other health care providers, the patients themselves, and their families. Other therapeutic requests such as dietary changes and weight control may be even more difficult to maintain than taking pills. As part of a controlled experimental design implemented in an outpatient teaching hospital, an educational program was implemented to improve family member support for medical compliance among hypertensive patients. Family members were interviewed, counseled, and provided with a booklet for the purpose of educating and involving them in the home management of high blood pressure. The booklet identified ways the family member could assist the patient with medication compliance, appointment keeping, as well as diet and weight control. These items were identified and recorded as behavioral objectives in the booklet. Patients were followed for three years to assess long-term outcomes. Results showed a strong statistically significant difference between the experimental and control groups, with the experimental group demonstrating higher levels of appointment-keeping behavior, weight control, and BP under control (all p values less than .001). Analysis of the main effects of the educational program demonstrated that the family member support intervention accounted for the greatest decrease in diastolic blood pressure variability, R2 = .20, p less than .001. Cystic fibrosis (CF) remains the most common genetically inherited disease in the white population and its prognosis is affected by nutritional status. Adults with the disease are now surviving longer and new strategies are required to ensure that they maintain optimal nutrition. This article reports preliminary data from a randomized controlled trial of a 10-week home-based behavioral nutrition intervention, "Eat Well with CF." Outcome measures of weight change over 6 and 12 months and changes in CF-specific nutrition knowledge score, self-efficacy score, reported dietary fat intake and health-related quality-of-life score were compared between the intervention group (n=34) and a standard care control group (n=34). The hypotheses to be tested were that adults with CF completing "Eat Well with CF" would have an improved nutritional status, improvement in specific nutrition knowledge, and an improvement in self-efficacy regarding their ability to cope with a special diet, compared to those receiving standard care. There were substantial improvements in the intervention group's specific CF nutrition knowledge score, self-efficacy score, and reported fat intake compared to control, but no substantial change in body mass index or health-related quality of life over time. Home-based nutrition education incorporating behavioral strategies can be an effective way to support adults with CF, enabling improvement in self-management skills in relation to diet and pancreatic enzyme replacement therapy. This study revealed gaps in basic nutrition knowledge and skills, inadequate knowledge of diet-disease links and pancreatic enzyme replacement therapy. These need to be identified when subjects progress from pediatric to adult care, and programs such as "Eat Well with CF" are a useful adjunct for registered dietitians trying to manage this diverse but growing population. A commitment-based intervention was evaluated for improvement of adherence to a 10-day antibiotic regimen. Experimental Ss made verbal and written commitments for adherence and completed tasks designed to increase their investment in a medication regimen. Control Ss performed similarly structured tasks unrelated to the medical regimen. Adherence, measured by unannounced pill counts, was significantly higher for experimental subjects than for control Ss. Self-reported adherence was significantly correlated with posttest self-efficacy but not with pretest self-efficacy. Adherence to a medical regimen may be improved by strategies conceptually based on the investment model of commitment, which provides a useful framework for further study of adherence. To evaluate the capability of DietMatePro, a PDA-based dietary assessment program, to monitor dietary intake and to improve adherence to a dietary regimen.
                Randomized controlled trial.
                Overweight and obese (Body Mass Index (BMI) 25-40) participants without dietary restrictions.
                Participants (n = 174) were randomized to record usual dietary intake using either DietMatePro or a paper food diary for one week to compare concordance with 24-hr recall. At the week 1 visit, participants were individually counseled to follow the diet recommendations of the Ornish Prevention Diet for three weeks and continue monitoring food intake using the assigned method to estimate adherence to the intervention by monitoring condition.
                Spearman correlations between week 1 24-hr recall and the assigned recording method were compared to assess validity. Mean pre-post changes in intake measured by 24-hr recall were compared according to monitoring condition to measure adherence to the Ornish diet.
                Correlations of energy and nutrient values reported on the food label ranged from 0.41 to 0.71 for the DietMatePro condition versus 0.63 to 0.83 for the paper-based diary. Diet adherence was higher among DietMatePro (43%) compared to the paper diary (28%) group (p = 0.039).
                DietMatePro does not appear to produce more valid data than paper-based approaches. DietMatePro may improve adherence to dietary regimens compared to paper-based methods. Suboptimal adherence to self-administered medications is a common problem. The purpose of this study was to determine the effectiveness of a video-game intervention for improving adherence and other behavioral outcomes for adolescents and young adults with malignancies including acute leukemia, lymphoma, and soft-tissue sarcoma.
                A randomized trial with baseline and 1- and 3-month assessments was conducted from 2004 to 2005 at 34 medical centers in the United States, Canada, and Australia. A total of 375 male and female patients who were 13 to 29 years old, had an initial or relapse diagnosis of a malignancy, and currently undergoing treatment and expected to continue treatment for at least 4 months from baseline assessment were randomly assigned to the intervention or control group. The intervention was a video game that addressed issues of cancer treatment and care for teenagers and young adults. Outcome measures included adherence, self-efficacy, knowledge, control, stress, and quality of life. For patients who were prescribed prophylactic antibiotics, adherence to trimethoprim-sulfamethoxazole was tracked by electronic pill-monitoring devices (n = 200). Adherence to 6-mercaptopurine was assessed through serum metabolite assays (n = 54).
                Adherence to trimethoprim-sulfamethoxazole and 6-mercaptopurine was greater in the intervention group. Self-efficacy and knowledge also increased in the intervention group compared with the control group. The intervention did not affect self-report measures of adherence, stress, control, or quality of life.
                The video-game intervention significantly improved treatment adherence and indicators of cancer-related self-efficacy and knowledge in adolescents and young adults who were undergoing cancer therapy. The findings support current efforts to develop effective video-game interventions for education and training in health care. This paper reports the initial results of a pilot study to evaluate the acceptability and effectiveness of a program to enhance health literacy in low-income HIV-infected Latino men and women receiving antiretroviral therapy. Participants rated the program highly on measures of satisfaction, providing evidence of its acceptability. The effectiveness of the program was assessed in comparisons of the intervention (n = 41) and standard care only (n = 40) groups at baseline and 6-week intervals. Program participants showed significant improvement over comparison group participants on measures of HIV/AIDS and treatment-related knowledge and recognition and understanding of HIV terms. Although there were no significant changes in adherence mastery and behaviors during the 6-week follow up period, there were significant changes in program participants' knowledge about medication adherence. Future steps to examine the sustainability of the program in the medical management of patients are planned in addition to determining its long-range relative impact. Diets encouraging 10% or less fat energy intake have been advocated to prevent progression of coronary artery disease. In this study, a randomized, controlled, repeated measures experimental design was used to determine if reducing fat intake incrementally to an eventual goal of 10% of total energy intake would result in better dietary adherence than would an immediate reduction to 10%. After completing a lifestyle education program and receiving personal dietary counselling, volunteers recruited from a cardiac rehabilitation program (treatment group, n = 4; control group, n = 3) completed a 24-hour recall at two, four, and seven months post-intervention. At these intervals, subjects also spoke with the dietitian to set dietary targets for the incremental reduction group or reinforce them for the immediate reduction group. Neither group achieved the goal of reducing fat intake to 10% of total energy intake, a finding that suggests this may be an unrealistic target. Because both groups consumed about the same percentage of fat energy, there appeared to be no benefit from incremental reduction of fat intake as a strategy to improve dietary adherence. Low rates of adherence to hypertensive therapy limit patients' securing the full benefits of treatment. While some factors related to adherence have been identified research on the effectiveness of interventions to increase adherence levels is sparse. The present study was designed to assess the impact of a series of different interventions on a group of some 400 patients, all under the care of private physicians in a small community. A factorial design was employed to deliver four, sequential educational interventions, about four months apart, to randomly selected sub-groups. Interviews before and after each intervention provided information concerning self-reported adherence, health status, health beliefs, and personal characteristics. Pertinent medical records and pharmacy data were also obtained. The first intervention - printed material - did not significantly affect adherence. The second and fourth interventions - nurse telephone calls and social support - each increased medication taking and the third intervention - self-monitoring - led to better weight control. There was no cumulative impact of the interventions and different aspects of regimens were not significantly related to one another. One hundred seventy-seven men and women who had participated in an 18-month trial of behavioral interventions involving food provision and financial incentives were examined 12 months later. Food provision, but not financial incentives, led to better weight loss than standard behavioral treatment during the 18-month trial, but over 12 additional months of no-treatment follow-up, all treated groups gained weight, maintained only slightly better weight losses than a no-treatment control group, and did not differ from each other. Weight loss success during both active treatment and maintenance was associated with increase in exercise, decrease in percentage of energy from fat, increase in nutrition knowledge, and decrease in perceived barriers to adherence. Obesity treatment research should focus on developing better ways to maintain changes in the diet and exercise behaviors needed for sustained weight loss. The objective of this work was to evaluate the reach, effectiveness, adoption, and implementation of a brief behavioral dietary intervention and 2 supplemental components of diabetes self-management support: telephone follow-up calls and community resources enhancement.
                This was a 2 x 2 randomized, controlled trial investigating the incremental effects of telephone follow-up and community resources enhancement with 320 adult type 2 diabetes outpatients. METHODS. Key outcomes included behavioral (dietary patterns, fat intake), physiologic (HbA1c, lipids), and quality-of-life/patient satisfaction measures and were collected at baseline and 3- and 6-month follow-up.
                Despite high reach (76% patient participation), excellent adoption (all 12 primary care practices approached participated), and good implementation, there were few outcome differences among treatment conditions. There was significant improvement across conditions in most outcomes in each category at both follow-ups.
                A brief, computer-assisted, dietary goal-setting intervention basic treatment condition was moderately successful in producing dietary improvements but less so in producing biologic or quality-of-life outcomes. Additions of follow-up phone calls or a community resources enhancement component did not produce incremental improvements over this basic intervention. Few rigorously designed studies have documented the efficacy of interventions to improve medication adherence among patients prescribed highly active antiretroviral. Data are needed to justify the use of limited resources for these programs.
                A 2-arm, randomized, controlled trial evaluated the efficacy of a community-based, home-visit intervention to improve medication adherence. Participants were 171 HIV-infected adults prescribed a minimum of 3 antiretroviral agents. The majority had a past or current history of substance abuse. Subjects were randomly assigned to receive home visits for 1 year or usual care. Medication adherence was assessed with Medication Event Monitoring stem caps at 3-month intervals from randomization through 3 months after the conclusion of the intervention.
                A larger proportion of subjects in the intervention group demonstrated adherence greater than 90% compared with the control group at each time point after baseline. The difference over time was statistically significant (Extended Mantel-Haenszel test: 5.80, P = 0.02). A statistically significant intervention effect on HIV-RNA level or CD4 cell count was not seen, but there was a statistically significant association between greater than 90% adherence and an undetectable HIV-RNA over time (P < 0.03).
                Home visits from a nurse and a community worker were associated with medication adherence greater than 90% among a cohort of socially vulnerable people living with HIV/AIDS in northeastern United States. To describe the 1) lifestyle intervention used in the Finnish Diabetes Prevention Study, 2) short- and long-term changes in diet and exercise behavior, and 3) effect of the intervention on glucose and lipid metabolism.
                There were 522 middle-aged, overweight subjects with impaired glucose tolerance who were randomized to either a usual care control group or an intensive lifestyle intervention group. The control group received general dietary and exercise advice at baseline and had an annual physician's examination. The subjects in the intervention group received additional individualized dietary counseling from a nutritionist. They were also offered circuit-type resistance training sessions and advised to increase overall physical activity. The intervention was the most intensive during the first year, followed by a maintenance period. The intervention goals were to reduce body weight, reduce dietary and saturated fat, and increase physical activity and dietary fiber.
                The intervention group showed significantly greater improvement in each intervention goal. After 1 and 3 years, weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group, respectively. Measures of glycemia and lipemia improved more in the intervention group.
                The intensive lifestyle intervention produced long-term beneficial changes in diet, physical activity, and clinical and biochemical parameters and reduced diabetes risk. This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system. To assess the efficacy of a behavioral intervention designed to improve HIV medication adherence and reduce alcohol consumption among HIV-positive men and women.
                A randomized controlled trial conducted between July 2002 and August 2005.
                A behavioral research center in New York City.
                HIV-positive men and women (n = 143) who were on HIV antiretroviral medication and met criteria for hazardous drinking.
                Participants were randomly assigned to an 8-session intervention based on motivational interviewing and cognitive-behavioral skills building or a time- and content-equivalent educational condition.
                Viral load, CD4 cell count, and self-reported adherence and drinking behavior were assessed at baseline and at 3- and 6-month follow-ups.
                Relative to the education condition, participants in the intervention demonstrated significant decreases in viral load and increases in CD4 cell count at the 3-month follow-up and significantly greater improvement in percent dose adherence and percent day adherence. There were no significant intervention effects for alcohol use, however, and effects on viral load, CD4 cell count, and adherence were not sustained at 6 months.
                An 8-session behavioral intervention can result in improvement in self-report and biologic markers of treatment adherence and disease progression. This type of intervention should be considered for dissemination and integration into HIV clinics providing comprehensive care for HIV-positive persons with alcohol problems. Although the effect was attenuated over time, future studies might test the added effectiveness of booster sessions or ongoing adherence counseling. Patients with inflammatory bowel disease (IBD) suffer physical dysfunction and impaired quality of life (QOL), and need frequent health care. They often lack knowledge about their disease and desire more education. Educational interventions for other chronic diseases have demonstrated reduced health care use and increased knowledge, medication adherence and QOL.
                Sixty-nine participants were randomly assigned to formal IBD education and standard of care (pamphlets and ad hoc physician education) or standard of care alone. Assessment of IBD knowledge and QOL occurred at baseline, immediately posteducation and eight weeks posteducation. Participants documented medication adherence and health care use in diaries. Patient satisfaction was assessed at the end of the study.
                The education group had higher knowledge scores (P=0.000), perceived knowledge ratings (P=0.01) and patient satisfaction (P=0.001). There was a lower rate of medication nonadherence and health care use for the education group, but the differences were not significant. QOL indices did not change. Significant correlations were found for increased health care use in patients with poorer medication adherence (P=0.01) and lower perceived health (P=0.05).
                Formal IBD patient education improves knowledge, perceived knowledge and patient satisfaction. Further study of long-term effects may better demonstrate potential benefits for QOL, medication adherence and health care use. The aim of this study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, could improve adherence and metabolic control and decrease rates of hospital utilization among adolescents with chronically poorly controlled type 1 diabetes.
                A randomized controlled trial was conducted with 127 adolescents with type 1 diabetes and chronically poor metabolic control (HbA(1c) [A1C] > or =8% for the past year) who received their diabetes care in a children's hospital located in a major Midwestern city. Participants randomly assigned to MST received treatment for approximately 6 months. Data were collected at baseline and at 7 months posttest (i.e., treatment termination). Changes in A1C adherence, as measured by semistructured interviews and blood glucose meters and hospital admissions and emergency department visits, were assessed.
                In intent-to-treat analyses, participation in MST was associated with significant improvements in the frequency of blood glucose testing as assessed by blood glucose meter readings (F[1,125] = 16.75, P = 0.001) and 24-h recall interviews (F[1,125] = 6.70, P = 0.011). Participants in MST also had a decreasing number of inpatient admissions, whereas the number of inpatient admissions increased for control subjects (F[1,125] = 6.25, P = 0.014). Per protocol analyses replicated intent-to-treat analyses but also showed a significant improvement in metabolic control for adolescents receiving MST compared with control subjects (F[1,114] = 4.03, P = 0.047).
                Intensive, home-based psychotherapy improves the frequency of blood glucose testing and metabolic control and decreases inpatient admissions among adolescents with chronically poorly controlled type 1 diabetes. The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients.
                We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At M0, the study enrolled 244 HAART-treated patients who attended a medical consultation between September and December 1999 who were not included in another protocol. Patients in the intervention group (IG) were offered three individual sessions by trained nurses. The proportions of adherent patients at 6 months followup (M6) and the change in HIV RNA between M0 and M6 were measured.
                Between M0 and M6, HIV RNA significantly decreased in the 123 patients of the IG (mean difference = -0.22 log [+/-0.86], p =.013), while it increased (+0.12 log [+/-0.90], p =.14) in the 121 patients of the control group. However, the proportion of patients with HIV RNA <40 copies/mL remained similar in both groups. In an intent-to-treat analysis, the only significant predictor of 100% adherence at M6 was the intervention group (p =.05) after adjustment for baseline adherence (p =.001). Among the 202 patients with available data on adherence, the proportion of adherent patients was similar in both groups at M0 (58% vs. 63%, p =.59) but became higher in the IG at M6 (75% vs. 61%, p =.04).
                The educational and counseling intervention was efficient for increasing adherence to HAART and could be implemented in most clinical settings. To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems.
                A randomized controlled trial (SMART Couples Study) conducted between August 2000 and January 2004.
                Two HIV/AIDS outpatient clinics in New York City.
                Heterosexual and homosexual HIV-serodiscordant couples (n = 215) in which the HIV-seropositive partner had < 80% adherence at baseline. The sample was predominantly lower-income racial/ethnic minorities.
                Participants were randomly assigned to a four-session couple-focused adherence intervention or usual care. The intervention consisted of education about treatment and adherence, identifying adherence barriers, developing communication and problem-solving strategies, optimizing partner support, and building confidence for optimal adherence.
                Medication adherence at week 8 (2 weeks after the intervention) compared with baseline, assessed with a Medication Event Monitoring System cap.
                Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken (76% versus 60%) or doses taken within specified time parameters (58% versus 35%). Also, participants in the intervention arm were significantly more likely to achieve high levels of adherence (> 80%, > 90%, or > 95%) when compared with controls. However, in most cases, effects diminished with time, as seen at follow-up at 3 and 6 months.
                The SMART Couples program significantly improved medication adherence over usual care, although the level of improved adherence, for many participants, was still suboptimal and the effect was attenuated over time. To test repeatability and relative validity of a computerized and interviewer administered assessment.
                Using a context-based case-control trial, 41 adults with type 2 diabetes mellitus were randomized into four groups to complete dietary assessments (computerized or interviewer administered) at 0, 2 and 8 weeks and food records at 0 and 2 weeks. Repeatability of reported energy, total fat, saturated, polyunsaturated and monounsaturated fatty acids between the computerized and interviewer administered methods were assessed using repeated measures ANOVA. Paired t-tests and Pearson's correlations determined relative validity of the assessments.
                Thirty-one patients completed all visits. Statistically significant differences were found between computerized and interviewer administered data for total fat (p=0.048) and saturated fatty acids (p=0.019) between 0 and 2 weeks. Computerized assessments correlated better with food records (r=0.16-0.52) compared with interviewer administered assessments (r=-0.02 to 0.51).
                Computerized assessments saw a learning effect with repeated use indicating that users were becoming more familiar with the website with repeated use. Relative validity suggests that the website may capture more foods though this requires further investigation.
                By allowing patients to self-report their intakes on a computer, dietitians will have the ability to spend increased time with their patients counseling them toward change. This study compared the effects of a theoretically focused audiotape and a standard educational booklet on asthma preventive medication adherence and other asthma outcomes. Forty-six adult asthmatics were randomly assigned to receive either an experimental audiotape incorporating components of protection motivation theory, a standard asthma management booklet, both, or no educational materials. Outcomes were assessed at baseline, 3 months, and 6 months. Mean pharmacy-verified adherence improved 15% to 19% in the intervention groups and declined 22% in the control group at 6 months. Using analysis of covariance (ANCOVA) to control for baseline adherence, these changes were significant between the control and booklet group (t = 2.47; p = .02) and between control and combined group (t = 2.07; p = .04). Providing a minimal educational intervention can have a beneficial effect on asthma medication adherence that persists at least 6 months. To further validate and assess the reliability and validity of the Trust in Physician Scale.
                Consecutive adult patients (n = 414) from 20 community-based, primary care practices were enrolled in a prospective, 6-month study. At enrollment, subjects completed the 11-item Trust in Physician Scale plus measures of demographics, preferences for care, and satisfaction with care received from the physician. Continuity, satisfaction with care, and self-reported adherence to treatment were measured at 6 months. Reliability, construct validity, and predictive validity were assessed using correlation coefficients and analysis of variance techniques.
                The Trust in Physician Scale showed high internal consistency (Cronbach's alpha = .89) and good 1-month test-retest reliability (intraclass correlation coefficient = .77). As expected, trust increased with the length of the relationship and was higher among patients who actively chose their physician, who preferred more physician involvement, and who expected their physician to care for a larger proportion of their problems (P < 0.001 for all associations). Baseline trust predicted continuity with the physician, self-reported adherence to medication, and satisfaction at 6 months after adjustment for gender, age, education, length of the relationship, active choice of the physician, and preferences for care. After additional adjustment for baseline satisfaction with physician care, trust remained a significant predictor of continuity, adherence, and satisfaction.
                The Trust in Physician Scale has desirable psychometric characteristics and demonstrates construct and predictive validity. It appears to be related to, but still distinct from, patient satisfaction with the physician and, thus, provides a valuable additional measure for assessment of the quality of the patient-physician relationship. Despite formal recommendations for dietary change to reduce the incidence of ischaemic heart disease, the acceptability and effectiveness of the proposed diets have not been well investigated in population based studies. In this preliminary investigation of nutritional advice in a well population, subjects in one group practice were randomized to receive either dietary instruction or simple follow up without instruction. The dietary recommendations were well received, and a substantial proportion of subjects reported altering their diets in accordance with them. There were modest beneficial changes in plasma lipid levels among men. Thus, using general practice as an avenue for promoting dietary change is feasible, and may be effective among men. Current cancer prevention recommendations include reducing consumption of fat and increasing consumption of fruits and vegetables.
                Healthy women health maintenance organization members (n = 616) ages 40-70 were randomly assigned to either a nutrition intervention or a control intervention unrelated to diet. Intervention included two 45-min counseling sessions plus two brief follow-up telephone contacts. Counseling sessions included a 20-min, interactive, computer-based intervention using a touch-screen format. Intervention goals were reducing dietary fat and increasing fruit and vegetable consumption. Outcome measures included a food frequency questionnaire and the Fat and Fiber Behavior Questionnaire (FFBQ). Total serum cholesterol was also measured at baseline and 12 months.
                Twelve-month follow-up data showed improvements on all dietary outcome variables. Compared to the control, intervention participants reported significantly less fat consumption (3.75 points less for percentage of energy from fat), significantly greater consumption of fruit and vegetables combined (0.93 more servings per day), and a significant reduction in a behavioral measure of fat consumption (0.20 point change in the FFBQ). Group differences in total serum cholesterol, while in the desired direction, were not significant.
                In appropriate circumstances, moderate-intensity dietary interventions can show significant effects for periods of at least 1 year. This report describes a pilot study of a nursing intervention to increase adherence to combination therapy. The intervention was based on motivational interviewing (MI). Participants completed a baseline assessment using the computer-administered self-interview with audio (ACASI) data collection method and then were randomly assigned to the MI intervention or control condition. Nurse counselors met with participants in the MI intervention group for three adherence sessions. Two months following baseline, participants completed a follow-up assessment. Mean scores on ratings of missed medications were lower for participants in the intervention group than those in the control group. Although there were no significant differences in the number of medications missed during the past 4 days, participants in the MI group reported being more likely to follow the medication regimen as prescribed by their health care provider. The pilot study provided useful information about the acceptability of ACASI and the adequacy of intervention procedures. The results of this pilot study show promise for the use of MI as an intervention to promote adherence to antiretroviral medications. Affordable and effective antiretroviral therapy (ART) adherence interventions are needed for many patients to promote positive treatment outcomes and prevent viral resistance. We conducted a two-arm randomized trial (n = 40 men and women receiving and less than 95% adherent to ART) to test a single office session followed by four biweekly cell phone counseling sessions that were grounded in behavioral self-management model of medication adherence using data from phone-based unannounced pill counts to provide feedback-guided adherence strategies. The control condition received usual care and matched office and cell phone/pill count contacts. Participants were baseline assessed and followed with biweekly unannounced pill counts and 4-month from baseline computerized interviews (39/40 retained). Results showed that the self-regulation counseling delivered by cell phone demonstrated significant improvements in adherence compared to the control condition; adherence improved from 87% of pills taken at baseline to 94% adherence 4 months after baseline, p < 0.01. The observed effect sizes ranged from moderate (d = 0.45) to large (d = 0.80). Gains in adherence were paralleled with increased self-efficacy (p < 0.05) and use of behavioral strategies for ART adherence (p < 0.05). We conclude that the outcomes from this test of concept trial warrant further research on cell phone-delivered self-regulation counseling in a larger and more rigorous trial.
There is a need for further, long-term, good-quality studies using more standardized and validated measures of adherence to identify the interventions that should be used in practice to enhance adherence to dietary advice in the context of a variety of chronic diseases.