Palliative CareCARE-MobileNCT07654998
Mobile Health Application for Family Caregivers in Home Palliative Care
A study testing Mobile Health Application in people with Palliative Care and Cancer, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Cancer, Caregiver
- What is being tested?
- Mobile Health Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Simav Doc. Dr. Ismail Karakuyu State Hospital
Simav, Kütahya, 43500
Serkan Budak, 905385430616, serkan.budak@ksbu.edu.tr
About this study
Official title: 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).
Read the 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.
- Conditions
- Palliative Care, Cancer, Caregiver
- Being tested
- Mobile Health Application
- Keywords
- Mobile Health, Family Caregiver, Home Palliative Care, Caregiver Competence, Caregiver Burden
- Medical subject headings
- Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health Application Plus Usual Care | Experimental | 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. Receives: Behavioral: Mobile Health Application |
| Usual Care Alone | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
Secondary outcomes (5)
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.
Measured: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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.
Measured: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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.
Measured: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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.
Measured: During the 18-week study period
Hospitalizations
Hospitalizations will be assessed as the number of inpatient hospital admissions occurring during the study period. Higher values indicate greater healthcare utilization.
Measured: During the 18-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654998
- Sponsor's protocol ID
- KSBU-MHEALTH-PC-2026-01
- Acronym
- CARE-Mobile
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be made publicly available.
Publications
Kelley MM, Powell T, Camara D, Shah N, Norton JM, Deitelzweig C, Vaidy N, Hsiao CJ, Wang J, Bierman AS. Mobile Health Apps, Family Caregivers, and Care Planning: Scoping Review. J Med Internet Res. 2024 May 23;26:e46108. doi: 10.2196/46108.
PubMed 38781588Yang X, Li X, Jiang S, Yu X. Effects of Telemedicine on Informal Caregivers of Patients in Palliative Care: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Apr 8;12:e54244. doi: 10.2196/54244.
PubMed 38602303Yu Y, Xue H, Suo C, Wang H, Pang Y, Ji C, Hou W, Lu Y, Lu D, Sang L, Xu J, Li C, Jin L, Shi L, Zhang J, Liang J, Zhao W, Chen X. Palliative Care Educational App for Family Caregivers of Homebound Patients With Incurable Cancer : A Single-Center Randomized Trial. Ann Intern Med. 2025 Dec;178(12):1737-1751. doi: 10.7326/ANNALS-25-02346. Epub 2025 Sep 23.
PubMed 40982976
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Health Application for Family Caregivers of Patients Receiving Home Palliative Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07654998
- Acronym / sponsor ID
- CARE-Mobile / KSBU-MHEALTH-PC-2026-01
- Conditions
- Palliative Care, Cancer, Caregiver
- Keywords
- Mobile Health, Family Caregiver, Home Palliative Care, Caregiver Competence, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Application Plus Usual Care | Experimental | Behavioral: Mobile Health ApplicationParticipants 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. |
| Usual Care Alone | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health ApplicationParticipants 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. | Behavioural | Mobile Health Application Plus Usual Care |
Primary outcome
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.
5 secondary outcomes
Zarit Burden Interview
Time frame: 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
Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version
Time frame: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
Emergency Department Visits
Time frame: During the 18-week study period
Hospitalizations
Time frame: During the 18-week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 38781588Kelley MM, Powell T, Camara D, Shah N, Norton JM, Deitelzweig C, Vaidy N, Hsiao CJ, Wang J, Bierman AS. Mobile Health Apps, Family Caregivers, and Care Planning: Scoping Review. J Med Internet Res. 2024 May 23;26:e46108. doi: 10.2196/46108.
- Background: PubMed 38602303Yang X, Li X, Jiang S, Yu X. Effects of Telemedicine on Informal Caregivers of Patients in Palliative Care: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Apr 8;12:e54244. doi: 10.2196/54244.
- Background: PubMed 40982976Yu Y, Xue H, Suo C, Wang H, Pang Y, Ji C, Hou W, Lu Y, Lu D, Sang L, Xu J, Li C, Jin L, Shi L, Zhang J, Liang J, Zhao W, Chen X. Palliative Care Educational App for Family Caregivers of Homebound Patients With Incurable Cancer : A Single-Center Randomized Trial. Ann Intern Med. 2025 Dec;178(12):1737-1751. doi: 10.7326/ANNALS-25-02346. Epub 2025 Sep 23.
- Individual participant dataSharing planned: No. Individual participant data collected during the study will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Application in people with Palliative Care and Cancer, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serkan Budak, PhD / RN (+905385430616, serkan.budak@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Competency Scale for Family Caregivers in Home Palliative Care (time frame: Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07654998, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.