Mobile Health Application for Family Caregivers in Home Palliative Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKutahya Health Sciences University
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile Health Application
BehavioralParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Mobile Health Application Plus Usual CareExperimental treatment 1 intervention
Group B: Usual Care AloneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Care Competency Scale for Family Caregivers in Home Palliative Care
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.
Time frame
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeksSecondary outcomes
1
Zarit Burden Interview
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.
Time frame
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks2
General Self-Efficacy Scale
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.
Time frame
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks3
Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version
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.
Time frame
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks4
Emergency Department Visits
Emergency department visits will be assessed as the number of emergency department admissions occurring during the study period. Higher values indicate greater healthcare utilization.
Time frame
During the 18-week study periodOther outcomes
1
Mobile Application Login Frequency
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.
Time frame
During the 6-week intervention period2
Mobile Application Use Duration
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.
Time frame
During the 6-week intervention period3
Educational Module Completion Rate
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.
Time frame
During the 6-week intervention period4
Monitoring Activity Completion Rate
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.
Time frame
During the 6-week intervention periodSponsors and contacts
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Source ClinicalTrials.gov
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