ECHO-COPD: Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention Among COPD Patients (ECHO-COPD)

Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention on Medication Adherence, Quality of Life, and Direct Cost Among COPD Patients at Buraidah Central Hospital in Al-Qassim Region, Saudi Arabia: A Quasi-Experimental Design

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.

A quantitative, quasi-experimental pretest-posttest control-group design will be used. 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 continue to receive standard care without additional educational input. Baseline assessments will include medication adherence using the 8-item Morisky Medication Adherence Scale (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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Medication Adherence; Chronic Obstructive Pulmonary Disease (COPD); Cost; Health Belief Model
• Intervention / Treatment: Behavioral: Pharmacist-Led HBM-Based Educational Intervention

Detailed Description

The HBM will guide the content and delivery of the pharmacist-led educational intervention. The intervention will address the six core constructs of the HBM:

1. Perceived susceptibility
2. Perceived severity
3. Perceived benefits
4. Perceived barriers
5. Cues to action
6. Self-efficacy The purpose of applying the HBM is to influence patients' understanding of COPD and promote positive behavioural changes, particularly improvements in medication adherence. The study will then examine the relationship between these improvements and quality of life, healthcare utilisation, and direct healthcare costs.

The intervention will consist of structured face-to-face educational sessions conducted in the designated counselling room of the Pulmonary Department at BCH. Sessions will incorporate printed educational materials, lectures, counselling, practical demonstrations, motivational support, problem-solving strategies, and reinforcement of behavioural changes.

The educational programme will cover aspects of COPD management, medication adherence and appropriate medication use, COPD risk factors and complications, nutrition and preventive care, smoking cessation, barriers to recommended behaviours, cues to action, and strategies to improve patients' confidence in managing COPD.

Participants in the intervention and control groups will undergo pre-intervention assessments. Participants in the intervention group will subsequently receive the structured educational programme, while the control group will continue to receive standard care without additional educational input. Post-intervention assessments will use the same measurement instruments to allow within-group and between-group comparisons.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bander S Alshammeri, MSc; Phone Number: +966509466669; Email: bandershe3@gmail.com
• Study Contact Backup: Name: Rabia Hussain, PhD, Lecturer; Phone Number: +6046534085; Email: rabia.hussain@usm.my

Study Locations

• Saudi Arabia
  • Al-Qassim Region
    • Buraidah, Al-Qassim Region, Saudi Arabia, 52391
      • Bander S Alshammeri
      • Contact: Bander S Alshammeri, MSc; Phone Number: +966509466669; Email: bandershe3@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must:

1. Be adults aged 18-65 years.
2. Be diagnosed with COPD stages I-III according to GOLD guidelines.
3. Have visited or been admitted for a COPD exacerbation and be receiving care at BCH in Al-Qassim Region, Saudi Arabia.
4. Be Arabic-speaking and capable of understanding study instructions.
5. Be willing and able to provide written informed consent.

Exclusion Criteria:

Participants will be excluded if they:

1. Are diagnosed with COPD stage IV.

2. Have another significant pulmonary disease, including:

   • Asthma
   • Bronchiectasis
   • Pneumonia
   • Cystic fibrosis

3. Have a serious systemic illness, severe comorbidity, or central organ dysfunction, including:

   • Hepatic dysfunction
   • Renal dysfunction
   • Psychiatric impairment
   • Sensory impairment
4. Are immunocompromised or receiving immunosuppressive treatment.
5. Have psychological, sensory, or cognitive impairment that prevents meaningful participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HBM-Based Educational Intervention; 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; 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.
No Intervention: Standard Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	Change in medication adherence Measurement Tool 8-item Morisky Medication Adherence Scale (MMAS-8), prevalidated Arabic version Medication adherence will be assessed using MMAS-8 at baseline and following completion of the intervention.	Baseline and 6 months after initiation of the educational intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life and Health Status	Change in quality of life/health status Measurement Tool COPD Assessment Test (CAT), prevalidated Arabic version The CAT will be administered to participants in both groups at baseline and after completion of the intervention.	Baseline and 6 months after initiation of the educational intervention.
Direct Healthcare Costs	Change in direct medical costs associated with COPD Direct medical cost data will be obtained from the clinical cost centre of BCH. The costing analysis will include direct COPD-related healthcare resources such as: Medications; Laboratory tests; Chest X-rays; Oxygen therapy Other direct medical resources documented within the approved data-collection instrument will be included as applicable. Important Costing Specification The cost of delivering the educational intervention will not be included in the costing analysis. The economic component of this study focuses on the direct cost of illness associated with COPD rather than the cost of implementing the educational intervention.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBM Constructs	Changes in patients' health beliefs will be assessed using a structured, prevalidated Arabic HBM questionnaire. The questionnaire assesses: Perceived susceptibility; Perceived severity; Perceived benefits; Perceived barriers; Cues to action; Self-efficacy	Baseline and 6 months after initiation of the educational intervention.

Collaborators and Investigators

• Sponsor: Rabia Hussain
• Collaborators: Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 7, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 7, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Quality of life; Medication adherence; Chronic Obstructive Pulmonary Disease; Patient education; Self-management; Health Belief Model; Saudi Arabia; Behaviour change; COPD Assessment Test; HBM; Pharmacist-led education; Direct medical costs
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Pulmonary Disease, Chronic Obstructive; Medication Adherence
• Other Study ID Numbers: USM-DSAP-2026-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No