Mobile Health Application for Family Caregivers in Home Palliative Care

Официальное название

Effectiveness of a Mobile Health Application for Family Caregivers of Patients Receiving Home Palliative Care: A Randomized Controlled Trial

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое Mobile Health Application
  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 i

Первичные конечные точки

• Care Competency Scale for Family Caregivers in Home Palliative Care [Срок оценки: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks]

Вторичные конечные точки (5)

• Zarit Burden Interview [Срок оценки: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks]
• General Self-Efficacy Scale [Срок оценки: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks]
• Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version [Срок оценки: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks]
• Emergency Department Visits [Срок оценки: During the 18-week study period]
• Hospitalizations [Срок оценки: During the 18-week study period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Simav Doc. Dr. Ismail Karakuyu State Hospital — Simav

Публикации

• 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. PMID 38781588
• 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. PMID 38602303
• 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. PMID 40982976

Идентификаторы

NCT: NCT07654998 · KSBU-MHEALTH-PC-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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