Cancer, Caregiver, Palliative Care
Conditions
Keywords
Mobile Health, Family Caregiver, Home Palliative Care, Caregiver Competence, Caregiver Burden
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALMobile 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 in addition to routine home palliative care services.
Sponsors
Kutahya Health Sciences University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the mobile health intervention, participants and investigators cannot be blinded to group assignment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving access to the mobile health application in addition to usual home palliative care services or a control group receiving usual home palliative care services alone. Outcomes will be assessed at baseline, Week 6, and Week 18.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Care Competency Scale for Family Caregivers in Home Palliative Care | Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview | Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks | 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. |
| General Self-Efficacy Scale | Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks | 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. |
| Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version | Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks | 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. |
| Emergency Department Visits | During the 18-week study period | Emergency department visits will be assessed as the number of emergency department admissions occurring during the study period. Higher values indicate greater healthcare utilization. |
| Hospitalizations | During the 18-week study period | Hospitalizations will be assessed as the number of inpatient hospital admissions occurring during the study period. Higher values indicate greater healthcare utilization. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSerkan Budak, PhD / RN
Outcome results
None listed