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

perjantai 24. heinäkuuta 2026 päivittänyt: 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).

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

120

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Turkki (Türkiye)
    • Kütahya
      • Simav, Kütahya, Turkki (Türkiye), 43500
        • Rekrytointi
        • Simav Doc. Dr. Ismail Karakuyu State Hospital
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Tukevaa hoitoa
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Käyttäytyminen: 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.
Ei väliintuloa: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Care Competency Scale for Family Caregivers in Home Palliative Care
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Zarit Burden Interview
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Mobile Application Login Frequency
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Kutahya Health Sciences University

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Ensimmäinen lähetetty

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Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 12. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 17. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 27. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 24. heinäkuuta 2026

Viimeksi vahvistettu

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Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • KSBU-MHEALTH-PC-2026-01

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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

Lääke- ja laitetiedot, tutkimusasiakirjat

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Ei

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