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

12. juni 2026 opdateret af: 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Mobile Application Usage and Adherence
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kutahya Health Sciences University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juni 2026

Primær færdiggørelse (Anslået)

30. oktober 2026

Studieafslutning (Anslået)

30. oktober 2026

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KSBU-MHEALTH-PC-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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