ECHO-COPD: Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention Among Chronic Obstructive Pulmonary Disease Patients

NCT07815353 | Not Yet Recruiting DMC

• 1 other identifier: USM-DSAP-2026-002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease associated with substantial morbidity and mortality, impaired quality of life, and healthcare costs. Medication adherence and appropriate self-management are important components of COPD management; however, patients' health beliefs and perceptions may influence their adherence to treatment and engagement in recommended health behaviours. This study aims to evaluate the impact of a pharmacist-led educational intervention based on the Health Belief Model (HBM) on medication adherence, quality of life, and direct healthcare costs among patients with COPD receiving care at Buraidah Central Hospital (BCH) in Al-Qassim Region, Saudi Arabia. This study will use a quantitative, quasi-experimental pretest-posttest control-group design. Eligible COPD patients will be non-randomly assigned to either an intervention group or a control group. The intervention group will receive structured, pharmacist-led HBM-based educational sessions in addition to routine care. In contrast, the control group will receive standard care without additional education. Baseline assessments will include medication adherence using the Morisky Medication Adherence Scale-8 (MMAS-8); quality of life and health status using the COPD Assessment Test (CAT); health beliefs using a structured HBM questionnaire; and direct medical costs obtained from the hospital clinical cost centre. The educational intervention will be delivered over six months, followed by post-intervention assessment using the same outcome measures.

Conditions

Chronic Obstructive Pulmonary Disease; Medication Adherence; Quality of Life; Cost; Health Belief Model

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Health Belief Model; HBM; Medication adherence; Pharmacist-led education; Patient education; Quality of life; COPD Assessment Test; Direct medical costs; Self-management; Behaviour change; Saudi Arabia

Outcome Measures

Primary Outcomes (1)

• Medication Adherence

  Outcome Measure: Change in Medication Adherence Assessed by the Morisky Medication Adherence Scale-8. Measurement Tool: Morisky Medication Adherence Scale-8 (MMAS-8), prevalidated Arabic version. The MMAS-8 is an 8-item self-reported measure of medication-taking behaviour, with a total score ranging from 0 to 8. Higher scores indicate better medication adherence, whereas lower scores indicate poorer adherence. Scores are commonly classified as low adherence (\<6), medium adherence (6 to \<8), and high adherence (8).

  Baseline and 6 months after initiation of the educational intervention.

Secondary Outcomes (2)

• Quality of Life and Health Status

  Baseline and 6 months after initiation of the educational intervention.

• Direct Healthcare Costs

  Direct medical costs assessed during the pre-intervention baseline period and during the post-intervention follow-up period after completion of the six-month intervention.

Other Outcomes (1)

• HBM Constructs

  Baseline and 6 months after initiation of the educational intervention.

Study Arms (2)

HBM-Based Educational Intervention

EXPERIMENTAL

Participants in the intervention group will receive routine care together with structured pharmacist-led educational sessions based on the HBM. The educational intervention will be conducted face-to-face during scheduled outpatient appointments in the designated counselling room of the Pulmonary Department. The programme will be delivered from study months 4 to 9. Educational sessions will include: * Printed educational materials * Lectures * Individual counselling * Practical demonstrations * Personalised feedback * Problem-solving strategies * Motivational support * Interactive activities * Peer group discussions * Reinforcement of behavioural changes The six HBM constructs will guide the educational content.

Behavioral: Pharmacist-Led HBM-Based Educational Intervention

Standard Care

NO INTERVENTION

Participants in the control group will continue to receive routine/standard care provided by BCH. They will not receive the additional structured pharmacist-led HBM-based educational intervention. Both intervention and control participants will undergo the same baseline and post-intervention assessments.

Interventions

Pharmacist-Led HBM-Based Educational Intervention BEHAVIORAL

Participants in the intervention group will receive routine care together with structured pharmacist-led educational sessions based on the HBM. The educational intervention will be conducted face-to-face during scheduled outpatient appointments in the designated counselling room of the Pulmonary Department. The programme will be delivered from study months 4 to 9. Educational sessions will include: * Printed educational materials * Lectures * Individual counselling * Practical demonstrations * Personalised feedback * Problem-solving strategies * Motivational support * Interactive activities * Peer group discussions * Reinforcement of behavioural changes The six HBM constructs will guide the educational content.

HBM-Based Educational Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must:
• Be adults aged 18-65 years.
• Be diagnosed with chronic obstructive pulmonary disease (COPD) stages I-III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
• Have visited or been admitted for a COPD exacerbation and are receiving care at Buraidah Central Hospital (BCH) in Al-Qassim Region, Saudi Arabia.
• Be Arabic-speaking and capable of understanding study instructions.
• Be willing and able to provide written informed consent.

You may not qualify if:

• Participants will be excluded if they:
• Are diagnosed with COPD stage IV.
• Have another significant pulmonary disease, including: Asthma, bronchiectasis, pneumonia, or cystic fibrosis.
• Have a serious systemic illness, severe comorbidity, or central organ dysfunction, including: Hepatic dysfunction, renal dysfunction, psychiatric impairment or sensory impairment.
• Are immunocompromised or receiving immunosuppressive treatment.
• Have psychological, sensory, or cognitive impairment that prevents meaningful participation in the study.

Sponsors & Collaborators

• Rabia Hussain: lead
• Universiti Sains Malaysia: collaborator

Study Sites (1)

Bander S Alshammeri

Buraidah, Al-Qassim Region, 52391, Saudi Arabia

Location

MeSH Terms

Conditions

Medication Adherence; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bander S Alshammeri, MSc

CONTACT

+966509466669; bandershe3@gmail.com

Rabia Hussain, PhD, Lecturer

CONTACT

+6046534085; rabia.hussain@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the educational intervention, participants and the pharmacist delivering the intervention will be aware of group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR. Rabia Hussain, Principal Investigator

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)