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Recruiting NCT07634406

Nurse-Led Telehealth Frailty Management in Older Adults

No phase Interventional Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program.
Who it may be relevant to
Registry conditions: Frailty. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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 f

Primary outcome measures

  • Frailty Level Assessed by the FRAIL Scale [Time frame: Baseline, 6 weeks, and 18 weeks]
Secondary outcome measures (5)
  • Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale [Time frame: Baseline, 6 weeks, and 18 weeks]
  • Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale [Time frame: Baseline, 6 weeks, and 18 weeks]
  • Number of Falls During the Study Period [Time frame: From baseline to 18 weeks]
  • Number of Emergency Department Visits During the Study Period [Time frame: From baseline to 18 weeks]
  • Number of Hospitalizations During the Study Period [Time frame: From baseline to 18 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit — Simav

Publications

  • 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. PMID 33402043
  • 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. PMID 26947059
  • 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. PMID 11253156

Identifiers

NCT: NCT07634406 · KSBU-FRAIL-RCT-2026-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗