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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks, and 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serkan Budak, PhD / RN | Contact | +905385430616 | serkan.budak@ksbu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit | Simav | Kütahya | 43500 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33402043 | Background | 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. | |
| 26947059 | Background | 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. |
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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.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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. | Baseline, 6 weeks, and 18 weeks |
| 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. | From baseline to 18 weeks |
| 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. | From baseline to 18 weeks |
| Number of Hospitalizations During the Study Period | 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 |
| 11253156 | Background | 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. |