## Protocol Section
### Identification Module
**NCT ID:** NCT04154579

**Brief Title:** Arts & Health Education to Improve Health, Resilience, and Well-Being

**Official Title:** A Randomized Controlled Trial Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Chronic Health Conditions in Underserved Neighborhoods

#### Organization Study ID Info
**ID:** IRB#19-854
#### Organization
**Class:** OTHER
**Full Name:** The Cleveland Clinic
### Status Module
#### Completion Date
**Date:** 2020-06-23

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-09

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-06

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2020-06-23

**Type:** ACTUAL

#### Start Date
**Date:** 2019-07-01

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2019-11-06
**Type:** ACTUAL
**Study First Submit Date:** 2019-10-02
**Study First Submit QC Date:** 2019-11-04
**Why Stopped:** COVID-19 pandemic. Unable to restart as had hoped.
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** National Endowment for the Arts, United States

**Class:** UNKNOWN

**Name:** Cuyahoga Arts and Culture

**Class:** OTHER

**Name:** The Cleveland Clinic

#### Lead Sponsor

**Class:** OTHER

**Name:** Lisa Gallagher

#### Responsible Party

**Investigator Affiliation:** The Cleveland Clinic

**Investigator Full Name:** Lisa Gallagher

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is an 8-week randomized controlled trial to help address health, resilience, and well-being. Participants are randomized into either a health education group or an arts-based health education group. Both groups will attend for 8 weeks and various study assessments will be conducted in order to measure the experience and impact of the program. Anyone 18 years and older with a chronic health condition (for example, diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disorder, asthma, weight, anxiety, depression, cardiac, arthritis, multiple sclerosis, and many more) are eligible to participate.

**Detailed Description:** Within the healthcare field today there is an increased concern with public health, population health, wellness, and prevention, all of which include focusing on physical health, obesity, chronic health conditions, unhealthy lifestyles, aging, and mental health issues. As healthcare professionals attempt to improve individuals' health outcomes, quality of life, well-being, coping skills, and health indicators, they also must try to promote behavior change that helps keep patients out of the hospital. These are concerns faced by individuals of all ages, genders, ethnicities, cultural backgrounds, socioeconomic statuses, and diagnoses. Therefore, it is important to find multiple means of addressing these concerns with the various populations as it is likely that no one particular method would be effective for every individual.

Programs and interventions have been created to address health, resilience, and well-being at the individual and the social level. They demonstrate the importance of providing support, encouraging behavior changes, and reinforcing objectives determined by the healthcare system. Many of these programs have focused on improving resilience and increasing participants' ability to thrive or recover from the illnesses and challenges they face.

The broad problem to be addressed by this study is to assess if arts-based programs are superior to non-arts-based health education programs at improving individuals' physical and mental health outcomes, quality of life, well-being, resilience, coping skills, stress, and health indicators while promoting behavior change and keeping them out of the hospital. Previous programs have focused on improving resilience. Individual arts interventions such as music, art, craft, choir singing, writing, theater, and movement have been utilized and in many cases found to be helpful in addressing resilience, coping, health, and well-being; however, it is not known what effect a program utilizing multiple arts-based interventions would have on adults with chronic health conditions. The primary benefit of conducting research into the effectiveness of different arts-based programs is the identification of the specific benefits of programs aimed at influencing health, resilience, and well-being in individuals with a variety of chronic health conditions.

The purpose of this randomized controlled study is to determine the outcomes of an 8-week arts-based program on the health, resilience, and well-being of individuals with chronic health conditions in an outpatient underserved community setting as compared to outcomes from individuals participating in a separate 8-week-non-arts-based health education program in the same setting. The purpose of including a variety of arts experiences is so that individuals will hopefully find at least one art form to which they can relate and will utilize in their lives to assist with their health, resilience, and well-being. The non-arts-based program will include educational topics related to health, resilience, and well-being.

### Conditions Module

**Conditions:**

- Hypertension

- Diabetes

- Obesity

- COPD

- CHF

- High Cholesterol

- Asthma

- Chronic Pain

- Multiple Sclerosis

- Depression

- Anxiety

- Heart Diseases

- Stroke

**Keywords:**

- Chronic health conditions

- Arts-based program

- Health education program

- Health

- Resilience

- Well-being

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This is a randomized controlled trial utilizing a mixed methods, pre-post intervention, and parallel group analysis.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This is an 8 week, arts-based session that includes educational \& experiential components. Topics include: Introduction to Arts \& Health; Music, Well-Being, \& Resilience; Movement \& Physical Activity; Art \& Well-Being; Writing \& Communication/Self-Expression; Theater \& Socialization; Art Appreciation \& a Healthy Brain; \& Summary/Integration of the Arts into Daily Lives.

**Intervention Names:**

- Behavioral: HeRe We Arts

**Label:** HeRe We Arts

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** This is an 8 week, non-arts-based health education session that includes educational \& some experiential components. Topics include: Introduction to Health, Resilience, \& Well-Being; Nutrition \& Healthy Eating; Exercise, Chair Yoga, \& Sleep; Mental Health, Stress Management, \& Life Satisfaction; Holistic Approaches: Wellness, Integrative Medicine, \& Complementary \& Alternative Medicine; Chronic Illnesses \& Chronic Pain; Health \& Behaviors; Summary \& Navigating the Healthcare System.

**Intervention Names:**

- Behavioral: HeRe We Ed

**Label:** HeRe We Ed (Health Education Group)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HeRe We Arts

**Description:** Art Therapy interventions to promote health, resilience \& well-being will discussed; \& experiences such as key chain making, collaging on journal covers, creating sculpture garden will be utilized. Music therapy interventions such as lyric discussion, singing, instrument playing, \& music-assisted relaxation techniques will be utilized; \& discussion of use of music to elicit positive physical \& emotional responses will be held. Drums Alive (drumming \& movement) will be used to promote physical activity. Art appreciation will include discussion of public art forms. Journaling will include different techniques for journaling, writing poetry, etc. Theater games such as Password, Press Conference, Props Only, \& Draw What You Hear will be utilized. Chair yoga will be introduced as a form of exercise. Education will be provided on the various topics.

**Name:** HeRe We Arts

**Other Names:**

- Music Therapy

- Drums Alive

- Art Appreciation

- Journaling

- Theater Games

- Art Therapy

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- HeRe We Ed (Health Education Group)

**Description:** Educational components and some experiential components will be utilized to educate the participants on health, resilience, well-being, nutrition, healthy eating, weight management, eating disorders, obesity, exercise, physical activity, sleep hygiene and the importance of sleep, mental health, stress management, the importance of improving life satisfaction, holistic approaches, wellness, integrative medicine, complementary and alternative medicine, chronic illness, chronic pain, methods for dealing with chronic versus acute illnesses, changing behaviors and/or maintaining healthy behaviors in order to promote health and stay out of the hospital, and navigating the healthcare system. Specific experiential components will include Chair Yoga and Stress Management Techniques.

**Name:** HeRe We Ed

**Other Names:**

- Health Education

- Chair Yoga

- Stress Management Techniques

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Participants will identify a goal each week, and the next week they will report on whether or not they completed their goal. This does not include a scale. It is merely a Yes or No.

**Measure:** Weekly Take-Away Goals

**Time Frame:** Weeks 1-8

**Description:** Phenomenological interviews will be conducted in order to gather qualitative information regarding participants' experience with the program, as well as its impact and meaning in their lives. This does not include a scale. It involves open-ended, qualitative information that is shared.

**Measure:** Phone Interview

**Time Frame:** Week 9

**Description:** Survey to determine progress, maintenance, and/or follow through at Week 16 (2 months after completion of the program). This does not involve a scale. It seeks to determine if skills are still being used 16 weeks after the start of the program via the use of open-ended and multiple choice questions.

**Measure:** HeRe We Arts Week 16 Survey

**Time Frame:** Week 16

**Description:** Survey to determine progress, maintenance, and/or follow through at Week 16 (2 months after completion of the program). This does not involve a scale. It seeks to determine if skills are still being used 16 weeks after the start of the program via the use of open-ended and multiple choice questions.

**Measure:** HeRe We Ed Week 16 Survey

**Time Frame:** Week 16

#### Primary Outcomes

**Description:** Means of assessing change in mood. Contains 6 items, 3 negative \& 3 positive. Participants think about how they felt in the past 7 days \& rate the frequency of each item on a 4-point scale. Scale ranges include scores between 0 and 18. Higher scores indicate higher levels of happiness.

**Measure:** Change in Short Depression-Happiness Scale from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** Means of assessing change in mood. Contains 6 items, 3 negative \& 3 positive. Participants think about how they felt in the past 7 days \& rate the frequency of each item on a 4-point scale. Scale ranges include scores between 0 and 18. Higher scores indicate higher levels of happiness.

**Measure:** Change in Short Depression-Happiness Scale from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** Means of assessing change in mood. Contains 6 items, 3 negative \& 3 positive. Participants think about how they felt in the past 7 days \& rate the frequency of each item on a 4-point scale. Scale ranges include scores between 0 and 18. Higher scores indicate higher levels of happiness.

**Measure:** Change in Short Depression-Happiness Scale from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

**Description:** Participants answer 7 questions by choosing the answer that best describes their experience over the last 2 weeks. Designed to measure the feeling and functioning aspects of positive mental well-being. Scores range from 7 to 35. Higher scores represent higher positive mental well-being.

**Measure:** Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** Participants answer 7 questions by choosing the answer that best describes their experience over the last 2 weeks. Designed to measure the feeling and functioning aspects of positive mental well-being. Scores range from 7 to 35. Higher scores represent higher positive mental well-being.

**Measure:** Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** Participants answer 7 questions by choosing the answer that best describes their experience over the last 2 weeks. Designed to measure the feeling and functioning aspects of positive mental well-being. Scores range from 7 to 35. Higher scores represent higher positive mental well-being.

**Measure:** Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

**Description:** A 4-item measure designed to identify participants' abilities to cope with stress. It may be helpful for recognizing those who may need to learn techniques to help improve their coping skills and resilience. Scores range from 4-20. Scores of 4-13 represent low resilient copers, those of 14-16 represent medium resilient copers, and those of 17-20 represent high resilient copers.

**Measure:** Change in Brief Resilient Coping Scale from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** A 4-item measure designed to identify participants' abilities to cope with stress. It may be helpful for recognizing those who may need to learn techniques to help improve their coping skills \& resilience. Scores range from 4-20. Scores of 4-13 represent low resilient copers, those of 14-16 represent medium resilient copers, and those of 17-20 represent high resilient copers.

**Measure:** Change in Brief Resilient Coping Scale from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** A 4-item measure designed to identify participants' abilities to cope with stress. It may be helpful for recognizing those who may need to learn techniques to help improve their coping skills \& resilience. Scores range from 4-20. Scores of 4-13 represent low resilient copers, those of 14-16 represent medium resilient copers, and those of 17-20 represent high resilient copers.

**Measure:** Change in Brief Resilient Coping Scale from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

**Description:** Measures amount of physical activity. Asks participants how many times on average, over a 7-day period, they engage in strenuous, moderate, or mild exercise for more than 15 minutes, and the average frequency of activity that leads to increased heart rate. Scores range from 0-24. Higher scores indicate higher levels of physical activity.

**Measure:** Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** Measures amount of physical activity. Asks participants how many times on average, over a 7-day period, they engage in strenuous, moderate, or mild exercise for more than 15 minutes, and the average frequency of activity that leads to increased heart rate. Scores range from 0-24. Higher scores indicate higher levels of physical activity.

**Measure:** Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** Measures amount of physical activity. Asks participants how many times on average, over a 7-day period, they engage in strenuous, moderate, or mild exercise for more than 15 minutes, and the average frequency of activity that leads to increased heart rate. Scores range from 0-24. Higher scores indicate higher levels of physical activity.

**Measure:** Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

**Description:** A self-report measure to identify symptoms, feelings, behaviors, \& functions in the areas of physical, mental, \& social health. Raw scores for mental health and for physical health are translated into T-scores. The mean for the T-score is 50 and there is a standard deviation of 10. Therefore, a higher T-score represents higher physical health or higher mental health.

**Measure:** Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** A self-report measure to identify symptoms, feelings, behaviors, \& functions in the areas of physical, mental, \& social health. Raw scores for mental health and for physical health are translated into T-scores. The mean for the T-score is 50 and there is a standard deviation of 10. Therefore, a higher T-score represents higher physical health or higher mental health.

**Measure:** Change in PROMIS Scale v1.2 - Global Health from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** A self-report measure to identify symptoms, feelings, behaviors, \& functions in the areas of physical, mental, \& social health. Raw scores for mental health and for physical health are translated into T-scores. The mean for the T-score is 50 and there is a standard deviation of 10. Therefore, a higher T-score represents higher physical health or higher mental health.

**Measure:** Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

**Description:** At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.

**Measure:** Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.

**Measure:** Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** At the start of each session an investigator will take and document each participants' systolic and diastolic blood pressure.

**Measure:** Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

**Description:** At the start of each session an investigator will take and document each participant's heart rate.

**Measure:** Change in Heart Rate from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** At the start of each session an investigator will take and document each participant's heart rate.

**Measure:** Change in Heart Rate from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** At the start of each session an investigator will take and document each participant's heart rate.

**Measure:** Change in Heart Rate from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

**Description:** At the start of each session an investigator will take and document each participant's pulse oximetry.

**Measure:** Change in Pulse Oximetry from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** At the start of each session an investigator will take and document each participant's pulse oximetry.

**Measure:** Change in Pulse Oximetry from Week 8 to Week 16

**Time Frame:** Weeks 8 and 16

**Description:** At the start of each session an investigator will take and document each participant's pulse oximetry.

**Measure:** Change in Pulse Oximetry from Week 1 to Week 16

**Time Frame:** Weeks 1 and 16

#### Secondary Outcomes

**Description:** A pre-test/post-survey utilized to test knowledge on arts and well-being, as well as satisfaction at endpoints. This is not a standardized measure and does not include a scale. It involves changes in knowledge and use of arts techniques, as well as satisfaction with the program via the use of open-ended and multiple choice questions.

**Measure:** Change in HeRe We Arts Survey from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** A pre-test/post-test utilized to test knowledge on health education \& well-being, as well as satisfaction, at endpoints. This is not a standardized measure and does not include a scale. It involves changes in knowledge and use of arts techniques, as well as satisfaction with the program via the use of open-ended and multiple choice questions.

**Measure:** Change in HeRe We Ed Survey from Week 1 to Week 8

**Time Frame:** Weeks 1 and 8

**Description:** Completed by participants at the end of each session in order to obtain information on learning and satisfaction. This is not a standardized measure and does not include a scale. It involves changes in knowledge and use of arts techniques, as well as satisfaction with the program via the use of open-ended and multiple choice questions.

**Measure:** Weekly Post-Session Survey

**Time Frame:** Weeks 1-8

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* At least 18 years old
* Diagnosed with at least one chronic health condition (as reported by the participant)
* Able to participate safely in all program sessions
* Proficient in English
* Cognitively able to consent to participate

Exclusion Criteria:

* Severe visual or auditory impairment
* Severe and/or uncontrolled comorbidity precluding safe participation in the program

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Euclid

**Country:** United States

**Facility:** Cleveland Clinic Euclid Hospital

**State:** Ohio

**Zip:** 44119

#### Overall Officials

**Official 1:**

**Affiliation:** The Cleveland Clinic

**Name:** Lisa M Gallagher, MA

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000006949

- Term: Hyperlipidemias

- ID: D000050171

- Term: Dyslipidemias

- ID: D000052439

- Term: Lipid Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M15415

- Name: Sclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M4556

- Name: Asthma

- Relevance: LOW

- As Found: Unknown

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M9988

- Name: Hypercholesterolemia

- Relevance: HIGH

- As Found: High Cholesterol

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M10000

- Name: Hyperlipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M10002

- Name: Hyperlipoproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M26181

- Name: Dyslipidemias

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27029

- Name: Lipid Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000006331

- Term: Heart Diseases

- ID: D000006937

- Term: Hypercholesterolemia

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-24
