Nurse-Led Telehealth Frailty Management in Older Adults
24. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
100
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Serkan Budak, PhD / RN
- Telefonnummer: +905385430616
- E-Mail: serkan.budak@ksbu.edu.tr
Studienorte
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Kütahya
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Simav, Kütahya, Türkei (türkiye), 43500
- Rekrutierung
- Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit
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Kontakt:
- Serkan Budak, PhD / RN
- Telefonnummer: +905385430616
- E-Mail: serkan.budak@ksbu.edu.tr
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
|
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.
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Kein Eingriff: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Frailty Level Assessed by the FRAIL Scale
Zeitfenster: Baseline, 6 weeks, and 18 weeks
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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.
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Baseline, 6 weeks, and 18 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale
Zeitfenster: Baseline, 6 weeks, and 18 weeks
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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.
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Baseline, 6 weeks, and 18 weeks
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Number of Falls During the Study Period
Zeitfenster: From baseline to 18 weeks
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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.
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From baseline to 18 weeks
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Number of Emergency Department Visits During the Study Period
Zeitfenster: From baseline to 18 weeks
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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.
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From baseline to 18 weeks
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Number of Hospitalizations During the Study Period
Zeitfenster: From baseline to 18 weeks
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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.
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From baseline to 18 weeks
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Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale
Zeitfenster: Baseline, 6 weeks, and 18 weeks
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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.
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Baseline, 6 weeks, and 18 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.
- Esfandiari E, Miller WC, Ashe MC. The Effect of Telehealth Interventions on Function and Quality of Life for Older Adults with Pre-Frailty or Frailty: A Systematic Review and Meta-Analysis. J Appl Gerontol. 2021 Nov;40(11):1649-1658. doi: 10.1177/0733464820983630. Epub 2021 Jan 6.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
5. Juni 2026
Primärer Abschluss (Geschätzt)
15. Oktober 2026
Studienabschluss (Geschätzt)
15. Oktober 2026
Studienanmeldedaten
Zuerst eingereicht
4. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Juni 2026
Zuerst gepostet (Tatsächlich)
8. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Juli 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KSBU-FRAIL-RCT-2026-01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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