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Medication non-adherence leads to recurrent admissions, worsening symptoms, poor quality of life, and increased healthcare costs in an already overburdened health system. Existing adherence interventions in Pakistan are limited, mostly educational, and rarely guided by behavioural theory, implementation science, or economic evaluation.
Therefore, a culturally appropriate, RE-AIM-informed autonomy-competence intervention is needed to improve medication adherence and quality of life among heart failure patients in Pakistan, while also assessing implementation feasibility and cost-effectiveness for future scale-up.
This study will employ a type 1 hybrid effectiveness-implementation randomized controlled trial to evaluate the clinical effectiveness, implementation outcomes, and cost-effectiveness of a RE-AIM-informed autonomy-competence intervention designed to improve medication adherence and quality of life among patients with heart failure. A parallel two-arm superiority trial design with a 1:1 allocation ratio will be used, in which participants will be randomly assigned to either the intervention group or the usual care group. The trial is theoretically grounded in the Self-Determination Theory, particularly the constructs of autonomy support and competence enhancement, while implementation evaluation will be guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Participants in the intervention arm will receive a digital RE-AIM-informed autonomy-competence intervention over four months. The intervention will aim to improve medication adherence by enhancing patients' autonomy, motivation, self-management confidence, and treatment competence. |
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| Control arm | No Intervention | Participants in the control group will receive standard routine cardiology care, including physician consultation, medication prescription, and usual counselling, without additional digital adherence support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RE-AIM-informed autonomy-competence intervention | Behavioral | Participants in the intervention arm will receive a digital RE-AIM-informed autonomy-competence intervention over four months. The intervention will aim to improve medication adherence by enhancing patients' autonomy, motivation, self-management confidence, and treatment competence. It will include individualized medication planning, shared decision-making, motivational counselling, adherence goal setting, structured medication education, pill-management support, symptom-monitoring guidance, problem-solving for adherence barriers, WhatsApp reminders, monthly telephonic follow-up, and reinforcement counselling. Family involvement will be encouraged where appropriate. Intervention fidelity will be monitored using delivery checklists, supervision, and periodic review. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence (self-efficacy) in heart failure patients | The first primary outcome will be medication adherence (self-efficacy) in heart failure patients, measured using the Self-Efficacy for Appropriate Medication Use Scale Urdu version (SEAMS-U) and pill count adherence assessment. The Self-Efficacy for Appropriate Medication Use Scale (SEAMS) is a 13-item tool measuring patient confidence in medication adherence. It typically uses a 3-point Likert scale (1=not confident, 2=fairly confident, 3=extremely confident). Scores range from 13 to 39, with higher scores indicating higher self-efficacy. | 3 months |
| Medication adherence (objective adherence rate) | The second primary outcome is medication adherence (objective adherence rate), will also be assessed using pill count methodology. Adherence rate will be calculated as the proportion of pills taken divided by the number of pills prescribed over the previous 30 days, expressed as a percentage. An adherence rate ≥80% will be considered adequate adherence. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure (HF)-specific Health-Related Quality of Life (HRQoL) | The Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used. It consists of 21 items, each scored on a 6-point Likert scale ranging from 0 to 5, where 0 indicates no impact, and 5 indicates a very severe impact of heart failure on the patient's life. The total score ranges from 0 to 105, with higher scores indicating poorer health-related quality of life. The questionnaire also includes two major subscales: the physical dimension (8 items; score range 0-40) and the emotional dimension (5 items; score range 0-25), with higher scores indicating poorer HRQoL. |
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Inclusion Criteria:
Age ≥18 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Arshed, Ph.D. | Contact | 00923337474464 | drarshedchaudhary@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Civil Hospital Karachi, Dr. Ruth K. M. Pfau Civil Hospital Karachi | Karachi | 74600 | Pakistan |
The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.
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It will be a two-arm randomized controlled trial
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Investigators and outcome assessors will remain blind regarding group allocation
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| 3 months |
| Implementation outcomes (RE-AIM domains) | Measured under the RE-AIM framework: Reach (% participants enrolled) Effectiveness (clinical + adherence outcomes) Adoption (provider uptake) Implementation (fidelity, dose, acceptability, feasibility) Validated tools: Acceptability of Intervention Measure (AIM) Feasibility of Intervention Measure (FIM) Intervention Appropriateness Measure (IAM). Higher scores indicate better measures | 3 months |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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