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

N/ANot Yet RecruitingNCT07815353

Rabia Hussain140 enrolled

Overview

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.

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.

Interventions

Pharmacist-Led HBM-Based Educational InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 6 months after initiation of the educational intervention.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.