SUPPORT-HEART-PK: Effectiveness, Implementation, and Cost-Effectiveness of a Theory-Based, RE-AIM-Informed Digital Self-Management Intervention for Heart Failure in Pakistan-A Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Aug 24, 2026 → Feb 24, 2027
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Record History

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  1. Primary completion pushed from Aug 24, 2026 to Feb 24, 2027 Show 5 more changesShow less
    • Start date: Jul 25, 2026 to Oct 15, 2026
    • Study completion pushed from Sep 15, 2026 to Feb 25, 2027
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study title expanded, about 7 words
  2. Start date: May 15, 2026 to Jul 25, 2026
    • Study title shortened, about 2 words
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07580508
Lead Sponsor Universiti Putra Malaysia
Conditions
(from sponsor)		 Heart Failure, Chronic Heart Failure (CHF)
Related terms Heart Failure, Medication Adherence
Enrollment 870 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov