AI-Based Personalized Self-Management for Patients With Heart Failure
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: AI-Based Personalized Self-Management Intervention
DeviceParticipants 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.
Behavioral: AI-Based Personalized Self-Management Intervention
BehavioralParticipants receive routine heart failure care, including standard education, outpatient follow-up, and prescribed treatment, without access to the AI-based application.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Experimental: AI-Based Personalized Self-Management InterventionExperimental treatment 1 intervention
Group B: Active Comparator: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)
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
Time Frame: Baseline, Week 6, and Week 122
Primary Outcome Measure 2: Health-Related Quality of Life (RAND-36)
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
Time Frame: Baseline, Week 6, and Week 12Secondary outcomes
1
Secondary Outcome Measure 1: Technology Acceptance of the AI-Based Intervention
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
Time Frame: Week 122
Secondary Outcome Measure 2: Participants' Experiences With the AI-Based Intervention
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
Time Frame: after completion of the 12-week intervention.Sponsors and contacts
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Source ClinicalTrials.gov
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