An interventional study of Pharmacist-Led HBM-Based Educational Intervention in Medication Adherence, Quality of Life and Cost, sponsored by Rabia Hussain. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Rabia Hussain · Not applicable, Interventional, and Health services research
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.
The Health Belief Model (HBM) will guide the content and delivery of the pharmacist-led educational intervention. The intervention will address six core HBM constructs: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. The purpose of applying the HBM is to improve patients' understanding of chronic obstructive pulmonary disease (COPD) and promote positive behavioural changes, particularly improved medication adherence.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's planned enrollment of 140 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Rabia Hussain is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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The criteria were revised on the registry on Sep 25, 2026. See what changed
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Participants must:
Exclusion Criteria:
Participants will be excluded if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
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).
Time frame: Baseline and 6 months after initiation of the educational intervention.
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.
Time frame: Baseline and 6 months after initiation of the educational intervention.
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.
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.
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.
Time frame: Baseline and 6 months after initiation of the educational intervention.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 11 months is below that.
Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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