AI-Based Personalized Self-Management for Patients With Heart Failure
Effectiveness of AI-Based Personalized Self-Management Intervention on Self-Care Behaviors and Health-Related Quality of Life Among Patients With Heart Failure
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Mohamed Fakhry Salem, PhD
- 전화번호: 01286038014
- 이메일: Mohamed.Fakhry@alexu.edu.eg
연구 연락처 백업
- 이름: Salem
- 이메일: Mohamed.Fakhry@alexu.edu.eg
연구 장소
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Alexandria, 이집트, 21511
- Faculty of Nursing, Alexandria University
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연락하다:
- Mohamed Fakhry Salem, PhD
- 전화번호: 01286038014
- 이메일: Mohamed.Fakhry@alexu.edu.eg
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Experimental: AI-Based Personalized Self-Management Intervention
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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. |
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활성 비교기: Active Comparator: Usual Care
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Participants receive routine heart failure care, including standard education, outpatient follow-up, and prescribed treatment, without access to the AI-based application. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)
기간: Time Frame: Baseline, Week 6, and Week 12
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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
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Primary Outcome Measure 2: Health-Related Quality of Life (RAND-36)
기간: Time Frame: Baseline, Week 6, and Week 12
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary Outcome Measure 1: Technology Acceptance of the AI-Based Intervention
기간: Time Frame: Week 12
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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: Week 12
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Secondary Outcome Measure 2: Participants' Experiences With the AI-Based Intervention
기간: Time Frame: after completion of the 12-week intervention.
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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: after completion of the 12-week intervention.
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Mohamed Fakhry Salem, PHD, Alexandria University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- AIHF-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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