AI-Based Personalized Self-Management for Patients With Heart Failure
Effectiveness of AI-Based Personalized Self-Management Intervention on Self-Care Behaviors and Health-Related Quality of Life Among Patients With Heart Failure
This study aims to evaluate the effectiveness of an AI-based personalized self-management intervention on self-care behaviors and health-related quality of life among patients with chronic heart failure. Using a two-phase sequential explanatory mixed-methods design, Phase I consists of a randomized controlled trial comparing a 12-week AI-guided self-management intervention plus usual care with usual care alone. Self-care behaviors and health-related quality of life will be assessed at baseline, 6 weeks, and 12 weeks. Phase II will involve semi-structured interviews with a purposively selected subgroup of intervention participants to explore their experiences with the AI-based intervention and to explain the quantitative findings. The study seeks to generate evidence on the effectiveness and patient acceptability of AI-supported self-management in heart failure care.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mohamed Fakhry Salem, PhD
- 电话号码：01286038014
- 邮箱：Mohamed.Fakhry@alexu.edu.eg
研究联系人备份
- 姓名：Salem
- 邮箱：Mohamed.Fakhry@alexu.edu.eg
学习地点
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Alexandria、埃及、21511
- Faculty of Nursing, Alexandria University
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接触：
- Mohamed Fakhry Salem, PhD
- 电话号码：01286038014
- 邮箱：Mohamed.Fakhry@alexu.edu.eg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Eligibility Criteria
Inclusion Criteria:
Adults aged 18 years or older. Confirmed diagnosis of chronic heart failure (NYHA Class II or III). Clinically stable for at least 1 month before enrollment. Able to read and understand Arabic. Own or have regular access to a smartphone compatible with the AI-based application.
Willing and able to provide informed consent and participate throughout the 12-week study period.
Exclusion Criteria:
NYHA Class IV or end-stage heart failure. Severe cognitive impairment or any condition preventing reliable self-reporting or informed consent.
Severe psychiatric illness that may interfere with study participation. Participation in another heart failure self-management or behavioral intervention program during the study period.
Inability to use a smartphone or the study application despite orientation and support.
Any serious medical condition deemed by the investigators to make participation inappropriate or unsafe.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Experimental: AI-Based Personalized Self-Management Intervention
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Participants receive a smartphone-based AI application delivering personalized self-management support for 12 weeks, including symptom monitoring, individualized self-care recommendations, medication and lifestyle reminders, educational content, and real-time guidance alongside usual care. |
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有源比较器：Active Comparator: Usual Care
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Participants receive routine heart failure care, including standard education, outpatient follow-up, and prescribed treatment, without access to the AI-based application. |
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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Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)
大体时间：Time Frame: Baseline, Week 6, and Week 12
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Description: Change in self-care behavior measured using the 9-item European Heart Failure Self-Care Behaviour Scale (EHFScBS-9). Scores are transformed to a 0-100 scale, with higher scores indicating better self-care behavior. |
Time Frame: Baseline, Week 6, and Week 12
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Primary Outcome Measure 2: Health-Related Quality of Life (RAND-36)
大体时间：Time Frame: Baseline, Week 6, and Week 12
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Description: Change in health-related quality of life measured using the RAND 36-Item Health Survey (RAND-36). Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. |
Time Frame: Baseline, Week 6, and Week 12
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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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Secondary Outcome Measure 1: Technology Acceptance of the AI-Based Intervention
大体时间：Time Frame: Week 12
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Description: Technology acceptance measured using an adapted AI Technology Acceptance Questionnaire based on the Modified Technology Acceptance Model (mTAM). The instrument consists of 16 items assessing Perceived Usefulness, Perceived Ease of Use, Behavioral Intention, and User Satisfaction. Items are rated on a 7-point Likert scale, with higher scores indicating greater acceptance of the AI-based intervention. |
Time Frame: Week 12
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Secondary Outcome Measure 2: Participants' Experiences With the AI-Based Intervention
大体时间：Time Frame: after completion of the 12-week intervention.
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Description: Participants' experiences, perceived benefits, barriers, facilitators, and recommendations regarding the AI-based personalized self-management intervention, assessed through semi-structured interviews and analyzed using thematic analysis. |
Time Frame: after completion of the 12-week intervention.
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合作者和调查者
调查人员
- 首席研究员：Mohamed Fakhry Salem, PHD、Alexandria University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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