## Protocol Section
### Identification Module
**NCT ID:** NCT06417931

**Brief Title:** Medication Adherence and Use of Inhaler Devices in Patients With Asthma or COPD

**Official Title:** A Pharmacist-Led Intervention on Medication Adherence and Inhaler Usage on Clinical Outcomes Among Patients With Asthma and Chronic Obstructive Pulmonary Disease in Ibadan, Nigeria

#### Organization Study ID Info
**ID:** Medication adherence
#### Organization
**Class:** OTHER
**Full Name:** University of Ibadan
### Status Module
#### Completion Date
**Date:** 2024-02-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-02-28

**Type:** ACTUAL

#### Start Date
**Date:** 2023-10-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Ibadan

#### Responsible Party

**Investigator Affiliation:** University of Ibadan

**Investigator Full Name:** Uyiose Fortress Ufuah

**Investigator Title:** Graduate Student

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study aims to evaluate the impact of a pharmacist-led intervention programme on medication adherence and use of inhaler devices on clinical outcomes of patients with asthma and COPD attending a tertiary health facility in Nigeria.

**Detailed Description:** Medication non-adherence in asthma and COPD patients have been established to be very high, and along-side poor knowledge of proper use of inhaler devices, results in suboptimal disease control among these patients. Studies evaluating the impact of a comprehensive intervention on medication adherence and inhaler usage on disease control are scare in developing countries. This study was a prospective single-blind quasi-randomized-controlled study among asthma and COPD patients attending the chest out-patient clinic of the University College Hospital, Ibadan. The baseline questionnaire was administered to consenting patients to explore demographic and specific clinical characteristics, knowledge of the disease, current medications, medication adherence, knowledge of use of metered dose (MDIs) and diskus inhalers, and asthma/COPD control status using the asthma control test (ACT) and COPD assessment test (CAT) scales. Subsequently, patients were assigned into intervention or control groups using odd or even number assignation. Patients in the intervention group were followed up for two months via face to face interviews, short message services, and phone calls at one-weekly intervals, so as to provide education and counseling to resolve the identified gaps during the baseline interaction. Descriptive statistics were used to summarize the data, while chi-square, t-test, Fishers exact test and Wilcoxon-signed ranked tests were used as appropriate to test for associations at p \< 0.05.

### Conditions Module

**Conditions:**

- Asthma COPD

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Quasi-randomised control trial

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 130

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Patients in the intervention group received education and counselling tips about their disease condition and medications

**Intervention Names:**

- Behavioral: Patient education and counselling

**Label:** Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** The pharmacist intervention was aimed at identifying and addressing barriers to treatment adherence through tailored strategies

**Name:** Patient education and counselling

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The difference between the intervention and control groups with respect to the changes in the medication adherence score from baseline to a 2-month follow-up.

**Measure:** Medication adherence

**Time Frame:** Two months

**Description:** The difference between the intervention and control groups with respect to the changes in knowledge of the use of inhaler devices from baseline to a 2-month follow-up.

**Measure:** Use of inhaler devices

**Time Frame:** Two months

#### Secondary Outcomes

**Description:** The difference in asthma or Chronic obstructive pulmonary disease (COPD) control among patients in control and intervention groups from baseline to 2-months follow-up

**Measure:** disease control

**Time Frame:** Two months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patients 18 years of age and older with a primary diagnosis of asthma or COPD by a physician who are willing to complete the study and have telephone access

Exclusion Criteria:

All non-consenting patients and patients who are not on any medications at any point in the study

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ibadan

**Country:** Nigeria

**Facility:** University College Hospital

**State:** Oyo State

**Zip:** 200212

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

- Version Holder: 2024-05-31
