SUPPORT-HEART-PK: Effectiveness, Implementation, and Economic Evaluation of Implementation, and Theory-Based Digital Self-Management Intervention for Heart Failure Management
2026年7月8日 更新者：Arshed Muhammad、Universiti Putra Malaysia
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
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.
研究概览
详细说明
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).
研究类型
介入性
注册 (估计的)
870
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Muhammad Arshed, Ph.D.
- 电话号码：00923337474464
- 邮箱：drarshedchaudhary@gmail.com
学习地点
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Karachi、巴基斯坦、74600
- Civil Hospital Karachi, Dr. Ruth K. M. Pfau Civil Hospital Karachi
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接触：
- Muhammad Arshed
- 电话号码：03337474464
- 邮箱：drarshedchaudhary@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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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, problem-solving for adherence barriers, WhatsApp reminders, monthly telephonic follow-up, and reinforcement counselling.
Family involvement will be encouraged where appropriate.
Intervention fidelity will be monitored using delivery checklists, supervision, and periodic review.
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无干预：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
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Medication adherence (self-efficacy) in heart failure patients
大体时间：3 months
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The first primary outcome will be medication adherence (self-efficacy) in heart failure patients, measured using the Self-Efficacy for Appropriate Medication Use Scale Urdu version (SEAMS-U) and pill count adherence assessment.
The Self-Efficacy for Appropriate Medication Use Scale (SEAMS) is a 13-item tool measuring patient confidence in medication adherence.
It typically uses a 3-point Likert scale (1=not confident, 2=fairly confident, 3=extremely confident).
Scores range from 13 to 39, with higher scores indicating higher self-efficacy.
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3 months
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Medication adherence (objective adherence rate)
大体时间：3 months
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The second primary outcome is medication adherence (objective adherence rate), will also be assessed using pill count methodology.
Adherence rate will be calculated as the proportion of pills taken divided by the number of pills prescribed over the previous 30 days, expressed as a percentage.
An adherence rate ≥80% will be considered adequate adherence.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Heart Failure (HF)-specific Health-Related Quality of Life (HRQoL)
大体时间：3 months
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The Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used.
It consists of 21 items, each scored on a 6-point Likert scale ranging from 0 to 5, where 0 indicates no impact, and 5 indicates a very severe impact of heart failure on the patient's life.
The total score ranges from 0 to 105, with higher scores indicating poorer health-related quality of life.
The questionnaire also includes two major subscales: the physical dimension (8 items; score range 0-40) and the emotional dimension (5 items; score range 0-25), with higher scores indicating poorer HRQoL.
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3 months
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Implementation outcomes (RE-AIM domains)
大体时间：3 months
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Measured under the RE-AIM framework: Reach (% participants enrolled) Effectiveness (clinical + adherence outcomes) Adoption (provider uptake) Implementation (fidelity, dose, acceptability, feasibility) Validated tools: Acceptability of Intervention Measure (AIM) Feasibility of Intervention Measure (FIM) Intervention Appropriateness Measure (IAM). Higher scores indicate better measures |
3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月25日
初级完成 (估计的)
2026年8月24日
研究完成 (估计的)
2026年9月15日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月8日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- BMUUU
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.
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研究美国 FDA 监管的药品
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研究美国 FDA 监管的设备产品
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.