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.
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.
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.
Parallel
Pharmacist-Led HBM-Based Educational Intervention
BehavioralParticipants 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.
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).
Quality of Life and Health Status
Outcome Measure: Change in Health Status Assessed by the COPD Assessment Test (CAT). Description: The prevalidated Arabic COPD Assessment Test (CAT) will be used to assess health status in patients with chronic obstructive pulmonary disease. The CAT contains 8 items, each scored from 0 to 5, giving a total score range of 0-40. Higher scores indicate a greater impact of COPD on health status and therefore a worse outcome; lower scores indicate better health status.
Direct Healthcare Costs
Change in direct medical costs associated with COPD Direct healthcare cost data will be obtained from the clinical cost centre of Buraidah Central Hospital (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.
HBM Constructs
Outcome Measure: Change in Health Beliefs Assessed by the Health Belief Model (HBM) Questionnaire. Description: A prevalidated Arabic Health Belief Model (HBM) questionnaire will assess six constructs using a 3-point Likert scale (Disagree=0, Neutral=1, Agree=2). Perceived susceptibility: 3 items, range 0-6; severity: 5 items, 0-10; benefits: 3 items, 0-6; barriers: 5 items, 0-10; cues to action: 5 items, 0-10; self-efficacy: 5 items, 0-10. Higher scores indicate greater levels of the respective construct. For perceived barriers, higher scores indicate more barriers and therefore a less favourable outcome.
Click on the lead sponsor to view all of their trials.
Rabia Hussain
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
Universiti Sains Malaysia
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
