NCT07634406

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

June 4, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 5, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

June 8, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

June 4, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

Older adultsTelehealthNursing interventionFrailty managementFunctional statusHome care

Outcome Measures

Primary Outcomes (1)

  • Frailty Level Assessed by the FRAIL Scale

    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

Secondary Outcomes (5)

  • Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale

    Baseline, 6 weeks, and 18 weeks

  • Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale

    Baseline, 6 weeks, and 18 weeks

  • Number of Falls During the Study Period

    From baseline to 18 weeks

  • Number of Emergency Department Visits During the Study Period

    From baseline to 18 weeks

  • Number of Hospitalizations During the Study Period

    From baseline to 18 weeks

Study Arms (2)

Nurse-Led Telehealth-Supported Frailty Management Program

EXPERIMENTAL

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.

Behavioral: Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program

Usual Care

NO INTERVENTION

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.

Interventions

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.

Nurse-Led Telehealth-Supported Frailty Management Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit

Simav, Kütahya, 43500, Turkey (Türkiye)

Location

Related Publications (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.

    PMID: 33402043BACKGROUND
  • 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.

    PMID: 26947059BACKGROUND
  • 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: 11253156BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Serkan Budak, PhD / RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to either the nurse-led telehealth-supported frailty management program group or the usual care group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 8, 2026

Study Start

June 5, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

June 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations