Mobile Health Application for Family Caregivers in Home Palliative Care (CARE-Mobile)
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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Serkan Budak, PhD / RN
- Telefonnummer: +905385430616
- E-post: serkan.budak@ksbu.edu.tr
Studiesteder
-
-
Kütahya
-
Simav, Kütahya, Tyrkia (Türkiye), 43500
- Rekruttering
- Simav Doc. Dr. Ismail Karakuyu State Hospital
-
Ta kontakt med:
- Serkan Budak
- Telefonnummer: 905385430616
- E-post: serkan.budak@ksbu.edu.tr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Care Competency Scale for Family Caregivers in Home Palliative Care
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Zarit Burden Interview
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mobile Application Login Frequency
Tidsramme: 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.
|
During the 6-week intervention period
|
|
Mobile Application Use Duration
Tidsramme: 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.
|
During the 6-week intervention period
|
|
Educational Module Completion Rate
Tidsramme: 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.
|
During the 6-week intervention period
|
|
Monitoring Activity Completion Rate
Tidsramme: 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.
|
During the 6-week intervention period
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Yang 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.
- Yu 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KSBU-MHEALTH-PC-2026-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .