About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Having advanced cognitive impairment such as dementia
Having hearing or speech problems that prevent communication
Being bedridden
Being in the terminal stage of illness
Trial design
Parallel
Treatments tested in this trial
Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale
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.
Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale
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.
Number of Falls During the Study Period
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.
Number of Emergency Department Visits During the Study Period
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.
Sponsors and contacts
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