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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed Fakhry Salem, PhD
- Número de teléfono: 01286038014
- Correo electrónico: Mohamed.Fakhry@alexu.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Salem
- Correo electrónico: Mohamed.Fakhry@alexu.edu.eg
Ubicaciones de estudio
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Alexandria, Egipto, 21511
- Faculty of Nursing, Alexandria University
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Contacto:
- Mohamed Fakhry Salem, PhD
- Número de teléfono: 01286038014
- Correo electrónico: Mohamed.Fakhry@alexu.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Secondary Outcome Measure 1: Technology Acceptance of the AI-Based Intervention
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamed Fakhry Salem, PHD, Alexandria University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AIHF-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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