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Life sciences · Interventional Study
ClinicalTrials.gov · September 25, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07841665). This is a study registration, not published results. Lead sponsor: Alexandria University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DEVICE: Experimental: AI-Based Personalized Self-Management Intervention; BEHAVIORAL: Behavioral: AI-Based Personalized Self-Management Intervention. Primary outcome measures: Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9) , Time Frame: Baseline, Week 6, and Week 12; Primary Outcome Measure 2: Health-Related Quality of Life (RAND-36) , Time Frame: Baseline, Week 6, and Week 12. Brief summary: 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.