SUPPORT-HEART-PK: Effectiveness, Implementation, and Economic Evaluation of Implementation, and Theory-Based Digital Self-Management Intervention for Heart Failure Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RE-AIM-informed autonomy-competence intervention.
- Who it may be relevant to
- Registry conditions: Heart Failure, Chronic Heart Failure (CHF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SUPPORT-HEART-PK: Effectiveness, Implementation, and Economic Evaluation of a RE-AIM-Informed, Theory-Based Digital Self-Management Intervention for Heart Failure Management-A Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial
Overview
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.
Detailed description
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).
Interventions
- Behavioral RE-AIM-informed autonomy-competence intervention
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, pro
Primary outcome measures
- Medication adherence (self-efficacy) in heart failure patients [Time frame: 3 months]
- Medication adherence (objective adherence rate) [Time frame: 3 months]
Secondary outcome measures (2)
- Heart Failure (HF)-specific Health-Related Quality of Life (HRQoL) [Time frame: 3 months]
- Implementation outcomes (RE-AIM domains) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Diagnosed heart failure for at least 6 months
- Prescribed ≥2 heart failure medications
- Documented medication non-adherence
- Able to provide informed consent
- Access to a smartphone
Exclusion criteria
- Severe psychiatric illness
- Terminal illness
- Severe cognitive impairment
- End-stage renal disease
- Participation in another intervention trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Pakistan · 1 center
- Civil Hospital Karachi, Dr. Ruth K. M. Pfau Civil Hospital Karachi — Karachi
Identifiers
NCT: NCT07580508 · BMUUU