SUPPORT-HEART-PK: Effectiveness, Implementation, and Economic Evaluation of Implementation, and Theory-Based Digital Self-Management Intervention for Heart Failure Management

Sponsor
Universiti Putra Malaysia
Study ID
NCT07580508
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
May 12, 2026
Start date
Jul 25, 2026
Status verified
Jul 2026
Primary completion
Aug 24, 2026
Completion
Sep 15, 2026

Study Design

Enrollment
870 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention arm
    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.
  • No Intervention: Control arm
    Participants in the control group will receive standard routine cardiology care, including physician consultation, medication prescription, and usual counselling, without additional digital adherence support

Primary Outcome Measure

Medication adherence (self-efficacy) in heart failure patients [ Time Frame: 3 months ]

Central Contacts

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