Mobile Health Application for Family Caregivers in Home Palliative Care (CARE-Mobile)
Effectiveness of a Mobile Health Application for Family Caregivers of Patients Receiving Home Palliative Care: A Randomized Controlled Trial
Family caregivers play a central role in providing daily care for patients receiving home palliative care. However, caregiving responsibilities may lead to increased burden, stress, and difficulties in symptom management and care coordination. Mobile health (mHealth) interventions may provide accessible education, symptom monitoring, and decision-support resources to improve caregiver outcomes and patient care.
The aim of this randomized controlled trial is to evaluate the effectiveness of a mobile health application developed for family caregivers of patients receiving home palliative care. The primary outcome is caregiver competence. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations.
A total of 120 family caregivers will be randomly assigned to either the intervention group, which will use the mobile health application for 6 weeks in addition to usual care, or the control group, which will receive usual care alone. Outcomes will be assessed at baseline, post-intervention (Week 6), and follow-up (Week 18).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Home palliative care services increasingly rely on family caregivers to provide symptom management, daily care, medication support, and coordination of healthcare services. Although family caregivers play a critical role in maintaining patient well-being, they frequently experience caregiving burden, psychological distress, and challenges in managing complex care needs. Strengthening caregiver competence and self-management skills may improve both caregiver and patient outcomes.
Mobile health technologies offer an opportunity to deliver structured educational and supportive interventions independent of time and location. Despite growing interest in digital health interventions, evidence regarding mobile applications specifically designed for family caregivers in home palliative care remains limited.
This study is a single-center, parallel-group, randomized controlled trial conducted at the Home Care Unit of Simav Doc. Dr. Ismail Karakuyu State Hospital, Kutahya, Türkiye. A total of 120 family caregivers of patients receiving home palliative care will be recruited and randomly allocated in a 1:1 ratio to either an intervention group or a control group.
Participants in the intervention group will receive access to a mobile health application developed for family caregivers. The application includes educational modules on palliative care and symptom management, daily care skills, medication management, nutrition and hygiene, prevention of pressure injuries, caregiver self-care, stress management, problem-solving, and decision-making regarding healthcare utilization. Participants will receive a brief orientation session and will use the application for 6 weeks. Application usage data will be recorded to assess intervention adherence.
Participants in the control group will continue to receive routine home palliative care services without access to the mobile application.
The primary outcome is caregiver competence, measured using the Care Competency Scale for Family Caregivers in Home Palliative Care. Secondary outcomes include caregiver burden, caregiver self-efficacy, patient symptom burden, emergency department visits, and hospitalizations. Assessments will be conducted at baseline (Week 0), immediately after the intervention period (Week 6), and at follow-up (Week 18).
The study is expected to provide evidence regarding the effectiveness of a mobile health intervention for improving caregiver competence and supporting patient care in home palliative care settings.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Serkan Budak, PhD / RN
- Número de teléfono: +905385430616
- Correo electrónico: serkan.budak@ksbu.edu.tr
Ubicaciones de estudio
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Kütahya
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Simav, Kütahya, Turquía (Türkiye), 43500
- Reclutamiento
- Simav Doc. Dr. Ismail Karakuyu State Hospital
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Contacto:
- Serkan Budak
- Número de teléfono: 905385430616
- Correo electrónico: serkan.budak@ksbu.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Family caregiver of a patient receiving home palliative care services.
- Aged 18 years or older.
- Providing unpaid care to the patient for at least 3 months.
- Able to read and understand Turkish.
- Owns or has regular access to a smartphone compatible with the mobile application.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Professional or paid caregivers.
- Participation in another structured caregiver support program during the study period.
- Cognitive, visual, or hearing impairments that would prevent effective use of the mobile application.
- Inability to complete study assessments.
- Withdrawal of consent at any stage of the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Mobile Health Application Plus Usual Care
Participants will receive access to a mobile health application designed for family caregivers of patients receiving home palliative care in addition to routine home palliative care services.
The intervention will be delivered for 6 weeks and includes educational content, symptom management support, caregiver self-care resources, medication management guidance, and healthcare utilization decision support.
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Participants in the intervention group will receive access to a mobile health application developed for family caregivers of patients receiving home palliative care.
The application includes educational modules on palliative care and symptom management, daily care skills, medication management, nutrition and hygiene, pressure injury prevention, caregiver self-care, stress management, problem-solving, and healthcare utilization decision support.
Participants will use the application for 6 weeks in addition to routine home palliative care services.
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Sin intervención: Usual Care Alone
Participants will receive routine home palliative care services provided by the home care unit.
No mobile health application or additional structured intervention will be provided during the study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Care Competency Scale for Family Caregivers in Home Palliative Care
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Caregiver competence will be assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care.
The scale consists of 29 items scored on a 1-5 Likert scale and evaluates caregiving knowledge, skills, preparedness, relational competence, emotional competence, and support-seeking competence.
Total scores range from 29 to 145, with higher scores indicating greater caregiver competence.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Zarit Burden Interview
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Caregiver burden will be assessed using the Zarit Burden Interview.
The scale consists of 22 items scored on a 5-point Likert scale.
Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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General Self-Efficacy Scale
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Caregiver self-efficacy will be assessed using the General Self-Efficacy Scale.
The scale consists of 10 items scored on a 4-point Likert scale.
Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version
Periodo de tiempo: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Patient symptom burden will be assessed using the proxy version of the Integrated Palliative Care Outcome Scale (IPOS).
The scale evaluates physical symptoms, emotional concerns, communication, and practical needs.
Total scores range from 0 to 68, with higher scores indicating greater symptom burden and unmet needs.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Emergency Department Visits
Periodo de tiempo: During the 18-week study period
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Emergency department visits will be assessed as the number of emergency department admissions occurring during the study period.
Higher values indicate greater healthcare utilization.
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During the 18-week study period
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Hospitalizations
Periodo de tiempo: During the 18-week study period
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Hospitalizations will be assessed as the number of inpatient hospital admissions occurring during the study period.
Higher values indicate greater healthcare utilization.
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During the 18-week study period
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mobile Application Login Frequency
Periodo de tiempo: During the 6-week intervention period
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The total number of application logins during the intervention period will be recorded using system-generated log data.
Higher values indicate more frequent use of the mobile application.
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During the 6-week intervention period
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Mobile Application Use Duration
Periodo de tiempo: During the 6-week intervention period
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The total duration of application use, measured in minutes, will be recorded using system-generated log data during the intervention period.
Higher values indicate greater use of the mobile application.
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During the 6-week intervention period
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Educational Module Completion Rate
Periodo de tiempo: During the 6-week intervention period
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The percentage of educational modules completed during the intervention period will be recorded using system-generated log data.
Higher percentages indicate greater adherence to the educational intervention.
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During the 6-week intervention period
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Monitoring Activity Completion Rate
Periodo de tiempo: During the 6-week intervention period
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The percentage of scheduled monitoring activities completed during the intervention period will be recorded using the Mobile Application Usage and Monitoring Form and system-generated log data.
Higher percentages indicate greater adherence to monitoring activities.
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During the 6-week intervention period
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Kelley MM, Powell T, Camara D, Shah N, Norton JM, Deitelzweig C, Vaidy N, Hsiao CJ, Wang J, Bierman AS. Mobile Health Apps, Family Caregivers, and Care Planning: Scoping Review. J Med Internet Res. 2024 May 23;26:e46108. doi: 10.2196/46108.
- Yang X, Li X, Jiang S, Yu X. Effects of Telemedicine on Informal Caregivers of Patients in Palliative Care: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Apr 8;12:e54244. doi: 10.2196/54244.
- Yu Y, Xue H, Suo C, Wang H, Pang Y, Ji C, Hou W, Lu Y, Lu D, Sang L, Xu J, Li C, Jin L, Shi L, Zhang J, Liang J, Zhao W, Chen X. Palliative Care Educational App for Family Caregivers of Homebound Patients With Incurable Cancer : A Single-Center Randomized Trial. Ann Intern Med. 2025 Dec;178(12):1737-1751. doi: 10.7326/ANNALS-25-02346. Epub 2025 Sep 23.
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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Más información
Términos relacionados con este estudio
Palabras clave
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Otros números de identificación del estudio
- KSBU-MHEALTH-PC-2026-01
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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