AI-Based Personalized Self-Management for Patients With Heart Failure

N/ANot Yet RecruitingNCT07841665

Alexandria University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

150

Conditions

Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 12

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 12

Secondary Outcomes

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 12

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.