Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Nurse-Led Telehealth Frailty Management in Older Adults

24. juli 2026 oppdatert av: Kutahya Health Sciences University

The Effect of a Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program on Frailty and Functional Status in Older Adults Living at Home: A Randomized Controlled Trial

Frailty is an important geriatric syndrome associated with reduced physiological reserve, functional decline, falls, hospitalization, and increased health care use among older adults. This randomized controlled trial aims to evaluate the effect of a nurse-led telehealth-supported multicomponent frailty management program on frailty level and functional status in older adults living at home.

The study will be conducted as a single-center, two-arm, parallel-group randomized controlled trial. A total of 100 older adults aged 65 years and older who are living at home and are frail or at risk of frailty will be randomly assigned to either the intervention group or the control group in a 1:1 ratio.

Participants in the intervention group will receive an 6-week nurse-led telehealth-supported frailty management program, including weekly telephone counseling and individualized follow-up. Participants in the control group will continue usual care. Data will be collected at baseline, at 6 weeks, and at 18 weeks. The primary outcome is frailty level measured using the FRAIL Scale. Secondary outcomes include functional status, depressive symptoms, number of falls, emergency department visits, and hospitalizations.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The intervention includes frailty awareness, physical activity and mobility support, nutrition and fluid intake counseling, fall prevention and home safety, sleep and fatigue management, self-management, and healthy lifestyle behaviors. The program will be delivered by a nurse through an initial face-to-face assessment and weekly telephone counseling sessions lasting approximately 20 to 25 minutes over 6 weeks. Intervention fidelity will be monitored using a standardized checklist.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Kütahya
      • Simav, Kütahya, Tyrkia (Türkiye), 43500
        • Rekruttering
        • Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Aged 65 years or older
  • Living at home and not receiving institutional care
  • Frail or at risk of frailty
  • Having sufficient hearing and cognitive ability to communicate by telephone
  • Able to read, understand, and communicate in Turkish
  • Providing written informed consent

Exclusion Criteria:

  • Having advanced cognitive impairment such as dementia
  • Having hearing or speech problems that prevent communication
  • Being bedridden
  • Being in the terminal stage of illness
  • Participating in another intervention or education program at the same time
  • Having a serious physical or psychiatric condition that may prevent regular participation in the intervention

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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: Nurse-Led Telehealth-Supported Frailty Management Program
Participants in this arm will receive an 6-week nurse-led telehealth-supported multicomponent frailty management program in addition to usual care. The program includes an initial face-to-face assessment and weekly telephone counseling sessions focused on frailty awareness, physical activity and mobility support, nutrition and fluid intake counseling, fall prevention and home safety, sleep and fatigue management, self-management, and healthy lifestyle behaviors.
Atferdsmessig: Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program
The intervention is a structured 6-week multicomponent program delivered by a nurse. Following baseline assessment and individualized goal setting, participants will receive weekly telephone counseling sessions lasting approximately 20 to 25 minutes. The intervention covers frailty awareness, physical activity and mobility support, nutrition and fluid intake counseling, fall prevention and home safety, sleep and fatigue management, self-management, and healthy lifestyle behaviors. Intervention fidelity will be monitored using a standardized checklist.
Ingen inngripen: Usual Care
Participants in this arm will continue their routine daily life and usual health care services. No structured frailty management intervention will be provided during the study period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Frailty Level Assessed by the FRAIL Scale
Tidsramme: Baseline, 6 weeks, and 18 weeks
Frailty level will be assessed using the FRAIL Scale. The FRAIL Scale consists of five components: fatigue, resistance, ambulation, illnesses, and weight loss. Total scores range from 0 to 5. Higher scores indicate greater frailty. A score of 0 indicates robust status, scores of 1 to 2 indicate pre-frailty, and scores of 3 to 5 indicate frailty.
Baseline, 6 weeks, and 18 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale
Tidsramme: Baseline, 6 weeks, and 18 weeks
Functional status will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Scale. Total scores range from 0 to 8. Higher scores indicate greater independence in instrumental activities of daily living.
Baseline, 6 weeks, and 18 weeks
Number of Falls During the Study Period
Tidsramme: From baseline to 18 weeks
The number of falls experienced by participants during the study period will be recorded using a fall and health care utilization form developed by the researchers. Data will be based on participant self-report. A higher number indicates more falls.
From baseline to 18 weeks
Number of Emergency Department Visits During the Study Period
Tidsramme: From baseline to 18 weeks
The number of emergency department visits during the study period will be recorded using a health care utilization form developed by the researchers. Data will be based on participant self-report. A higher number indicates greater emergency health care utilization.
From baseline to 18 weeks
Number of Hospitalizations During the Study Period
Tidsramme: From baseline to 18 weeks
The number of hospitalizations during the study period will be recorded using a health care utilization form developed by the researchers. Data will be based on participant self-report. A higher number indicates greater hospital utilization.
From baseline to 18 weeks
Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale
Tidsramme: Baseline, 6 weeks, and 18 weeks
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale. Total scores range from 0 to 15. Higher scores indicate more severe depressive symptoms. Scores of 0 to 4 indicate no depression, 5 to 8 indicate mild depression, 9 to 11 indicate moderate depression, and 12 to 15 indicate severe depression.
Baseline, 6 weeks, and 18 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kutahya Health Sciences University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2026

Primær fullføring (Antatt)

15. oktober 2026

Studiet fullført (Antatt)

15. oktober 2026

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KSBU-FRAIL-RCT-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared because the study involves older adults and contains sensitive health-related information. De-identified aggregate results may be reported in scientific publications.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Abonnere