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

NCT07841665 | Not Yet Recruiting

• 1 other identifier: AIHF-2026-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• 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: 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: Baseline, Week 6, and Week 12

Secondary Outcomes (2)

• 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.

Study Arms (2)

Experimental: AI-Based Personalized Self-Management Intervention

EXPERIMENTAL

Device: Experimental: AI-Based Personalized Self-Management Intervention

Active Comparator: Usual Care

ACTIVE COMPARATOR

Behavioral: Behavioral: AI-Based Personalized Self-Management Intervention

Interventions

Experimental: AI-Based Personalized Self-Management Intervention DEVICE

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.

Experimental: AI-Based Personalized Self-Management Intervention

Behavioral: AI-Based Personalized Self-Management Intervention BEHAVIORAL

Participants receive routine heart failure care, including standard education, outpatient follow-up, and prescribed treatment, without access to the AI-based application.

Active Comparator: Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Faculty of Nursing, Alexandria University

Alexandria, 21511, Egypt

Location

Faculty of Nursing, Alexandria University

Alexandria, 21511, Egypt

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mohamed Fakhry Salem, PHD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Fakhry Salem, PhD

CONTACT

01286038014; Mohamed.Fakhry@alexu.edu.eg

Salem

CONTACT

Mohamed.Fakhry@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)