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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Medication adherence (self-efficacy) in heart failure patients [Срок оценки: 3 months]
• Medication adherence (objective adherence rate) [Срок оценки: 3 months]

Вторичные конечные точки (2)

• Heart Failure (HF)-specific Health-Related Quality of Life (HRQoL) [Срок оценки: 3 months]
• Implementation outcomes (RE-AIM domains) [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Severe psychiatric illness
• Terminal illness
• Severe cognitive impairment
• End-stage renal disease
• Participation in another intervention trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Пакистан · 1 центр

• Civil Hospital Karachi, Dr. Ruth K. M. Pfau Civil Hospital Karachi — Karachi

Идентификаторы

NCT: NCT07580508 · BMUUU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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