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NCT Number: NCT07654998

Mobile Health Application for Family Caregivers in Home Palliative Care

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Simav Doc. Dr. Ismail Karakuyu State Hospital

Simav, Kütahya, 43500, Turkey (Türkiye)

Location status: Recruiting

Location contact

Serkan Budak

CONTACT

[email protected]

905385430616

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Health Application

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. Mobile Application Login Frequency

    Time frame: During the 6-week intervention period

    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.

  2. Mobile Application Use Duration

    Time frame: During the 6-week intervention period

    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.

  3. Educational Module Completion Rate

    Time frame: During the 6-week intervention period

    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.

  4. Monitoring Activity Completion Rate

    Time frame: During the 6-week intervention period

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Serkan Budak, PhD / RN

CONTACT

[email protected]

+905385430616

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Acronym: CARE-Mobile

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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