Effectiveness of AI-Based Personalized Self-Management Intervention on Self-Care Behaviors and Health-Related Quality of Life Among Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: AI-Based Personalized Self-Management Intervention
干预措施: Experimental: AI-Based Personalized Self-Management Intervention (Device)
Active Comparator: Usual Care
干预措施: Behavioral: AI-Based Personalized Self-Management Intervention (Behavioral)
结局指标
主要结局
Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)
时间窗: Time Frame: Baseline, Week 6, and Week 12
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.
Primary Outcome Measure 2: Health-Related Quality of Life (RAND-36)
时间窗: Time Frame: Baseline, Week 6, and Week 12
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.
次要结局
- Secondary Outcome Measure 1: Technology Acceptance of the AI-Based Intervention(Time Frame: Week 12)
- Secondary Outcome Measure 2: Participants' Experiences With the AI-Based Intervention(Time Frame: after completion of the 12-week intervention.)
研究者
Mohamed Fakhry Ahmed Salem
Dr
Alexandria University