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NCT07580508
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
Conditions: Heart Failure, Chronic Heart Failure (CHF)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 870
Sponsor: Universiti Putra Malaysia
Location: Civil Hospital Karachi, Dr. Ruth K. M. Pfau Civil Hospital Karachi Karachi
Summary
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.
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
Source: ClinicalTrials.gov (NCT07580508). StuddyBuddy aggregates publicly available trial information.