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Nurse-Led Telehealth Frailty Management in Older Adults

24 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Kütahya
      • Simav, Kütahya, Turquía (Türkiye), 43500
        • Reclutamiento
        • Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Frailty Level Assessed by the FRAIL Scale
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Kutahya Health Sciences University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de junio de 2026

Finalización primaria (Estimado)

15 de octubre de 2026

Finalización del estudio (Estimado)

15 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de julio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KSBU-FRAIL-RCT-2026-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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