Effectiveness of a Mobile Health Application for Family Caregivers of Patients Receiving Home Palliative Care: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the mobile health intervention, participants and investigators cannot be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Mobile Health Application (Behavioral)
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.