- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07634406
Nurse-Led Telehealth Frailty Management in Older Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Serkan Budak, PhD / RN
- Phone Number: +905385430616
- Email: serkan.budak@ksbu.edu.tr
Study Locations
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Kütahya
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Simav, Kütahya, Turkey (Türkiye), 43500
- Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit
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Contact:
- Serkan Budak, PhD / RN
- Phone Number: +905385430616
- Email: serkan.budak@ksbu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
No Intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, 6 weeks, and 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6 weeks, and 18 weeks
|
|
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 depressi
|
Baseline, 6 weeks, and 18 weeks
|
|
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.
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From baseline to 18 weeks
|
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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.
|
From baseline to 18 weeks
|
|
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.
|
From baseline to 18 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSBU-FRAIL-RCT-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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