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Nurse-Led Caregiver Support Program in Home Palliative Care (CARE-PAL)

4. juni 2026 opdateret af: Kutahya Health Sciences University

Effect of a Nurse-Led Caregiver Support Program on Caregiver Competency and Healthcare Utilization Among Family Caregivers in Home Palliative Care: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of a nurse-led caregiver support program on caregiver competency and healthcare utilization among family caregivers of patients receiving home palliative care. Family caregivers in the intervention group will receive a structured 6-week nurse-led support program including face-to-face education, weekly telephone coaching, caregiver guidance materials, and decision support for symptom management and healthcare utilization. The control group will continue to receive routine home palliative care services. Primary outcome is caregiver competency. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Palliative care aims to improve quality of life for individuals with life-threatening illnesses through symptom management and holistic care. In home palliative care settings, family caregivers play a critical role in providing daily care and symptom monitoring. However, caregiving responsibilities may lead to increased burden, stress, and inappropriate healthcare utilization.

This study is designed as a single-center, parallel-group, randomized controlled trial to evaluate the effectiveness of a nurse-led caregiver support program among family caregivers of patients receiving home palliative care services.

A total of 150 family caregivers will be recruited and randomized into intervention and control groups in a 1:1 ratio using computer-generated block randomization. Participants in the intervention group will receive a structured 6-week nurse-led caregiver support program consisting of an initial face-to-face educational session and weekly telephone coaching. Intervention content includes symptom management, daily care skills, medication management, complication recognition, caregiver self-care, stress management, and healthcare utilization decision support. Caregivers will also receive a caregiver guidebook and crisis management decision algorithm.

Participants in the control group will continue receiving routine home palliative care services without additional structured support.

Outcome assessments will be conducted at baseline (T0), post-intervention (T1), and 3-month follow-up (T2). The primary outcome is caregiver competency measured using the Care Competency Scale for Family Caregivers in Home Palliative Care. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations.

The study is expected to provide evidence regarding the effectiveness of nurse-led caregiver support interventions in home palliative care settings.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

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:

  • Adult family caregivers of patients receiving home palliative care services
  • Age 18 years or older
  • Being the primary caregiver responsible for the patient's daily care
  • Ability to communicate in Turkish
  • Willingness to participate in the study

Exclusion Criteria:

  • Professional or paid caregivers
  • Caregivers with severe cognitive impairment or severe psychiatric disorders
  • Inability to participate in follow-up assessments

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nurse-Led Caregiver Support Program
Participants will receive a structured nurse-led caregiver support program in addition to routine home palliative care services.
Adfærdsmæssigt: Nurse-Led Caregiver Support Program
Participants in the intervention group will receive a structured 6-week nurse-led caregiver support program including face-to-face education, weekly telephone coaching, caregiver guidance materials, symptom management support, medication management education, stress management strategies, and healthcare utilization decision support in addition to routine home palliative care services.
Ingen indgriben: Routine Home Palliative Care
Participants will receive routine home palliative care services.

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 3-month follow-up
Caregiver competency will be assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care. The scale includes 29 items scored on a 1-5 Likert scale. Total scores range from 29 to 145, with higher scores indicating greater caregiver competency.
Baseline, post-intervention at 6 weeks, and 3-month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Zarit Burden Interview
Tidsramme: Baseline, post-intervention at 6 weeks, and 3-month follow-up
Caregiver burden will be assessed using the Zarit Burden Interview. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Baseline, post-intervention at 6 weeks, and 3-month follow-up
General Self-Efficacy Scale
Tidsramme: Baseline, post-intervention at 6 weeks, and 3-month follow-up
Caregiver self-efficacy will be assessed using the General Self-Efficacy Scale. Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.
Baseline, post-intervention at 6 weeks, and 3-month follow-up
Integrated Palliative Care Outcome Scale
Tidsramme: Baseline, post-intervention at 6 weeks, and 3-month follow-up
Patient symptom burden will be assessed using the Integrated Palliative Care Outcome Scale proxy version. Total scores range from 0 to 68, with higher scores indicating greater symptom burden and unmet needs.
Baseline, post-intervention at 6 weeks, and 3-month follow-up
Emergency Department Visits
Tidsramme: Baseline, post-intervention at 6 weeks, and 3-month follow-up
Emergency department visits will be assessed as the number of emergency department visits during the follow-up period. Higher values indicate greater emergency healthcare utilization.
Baseline, post-intervention at 6 weeks, and 3-month follow-up
Hospitalizations
Tidsramme: During the 3-month follow-up period
Hospitalizations will be assessed as the number of hospital admissions during the follow-up period. Higher values indicate greater inpatient healthcare utilization.
During the 3-month follow-up 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)

12. maj 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KSBU-HPC-RCT-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Individual participant data sharing plans have not yet been determined. Data sharing decisions will be made after study completion in accordance with institutional policies and ethical considerations.

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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