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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 870
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and outcome assessors will remain blind regarding group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe psychiatric illness
- •Terminal illness
- •Severe cognitive impairment
- •End-stage renal disease
- •Participation in another intervention trial
研究组 & 干预措施
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.
干预措施: RE-AIM-informed autonomy-competence intervention (Behavioral)
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
研究者
Arshed Muhammad
Principal Investigator
Universiti Putra Malaysia