Mobile Health Application for Family Caregivers in Home Palliative Care (CARE-Mobile)

June 12, 2026 updated by: Kutahya Health Sciences University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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 in addition to routine home palliative care services.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Care Competency Scale for Family Caregivers in Home Palliative Care
Time Frame: 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.
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zarit Burden Interview
Time Frame: 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.
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
General Self-Efficacy Scale
Time Frame: 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.
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version
Time Frame: 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.
Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
Emergency Department Visits
Time Frame: 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.
During the 18-week study period
Hospitalizations
Time Frame: 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.
During the 18-week study period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobile Application Usage and Adherence
Time Frame: During the 6-week intervention period
Application usage and intervention adherence will be assessed using the Mobile Application Usage and Monitoring Form and system-generated log data. Measures will include login frequency, duration of use, module utilization, completion of monitoring activities, and overall engagement with the mobile application during the intervention period.
During the 6-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSBU-MHEALTH-PC-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected during the study will not be made publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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