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NCT Number: NCT07634406

Nurse-Led Telehealth Frailty Management in Older Adults

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Simav, Kütahya, 43500, Turkey (Türkiye)

Location status: Recruiting

Location contact

Serkan Budak, PhD / RN

CONTACT

[email protected]

+905385430616

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program

Behavioral

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.

Primary outcomes

  1. Frailty Level Assessed by the FRAIL Scale

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale

    Time frame: 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.

  3. Number of Falls During the Study Period

    Time frame: 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.

  4. Number of Emergency Department Visits During the Study Period

    Time frame: 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.

  5. Number of Hospitalizations During the Study Period

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Serkan Budak, PhD / RN

CONTACT

[email protected]

+905385430616

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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