FrailtyNCT07634406
Nurse-Led Telehealth Frailty Management in Older Adults
A study testing Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program in people with Frailty, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Frailty can make older adults more vulnerable to loss of independence, falls, and hospitalization. This study evaluated whether a six-week nurse-led telephone education and counseling program could improve frailty and daily functioning in older adults living at home. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2026to 22 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit
Simav, Kütahya, 43500
About this study
Official 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
Frailty can make older adults more vulnerable to loss of independence, falls, and hospitalization. This study evaluated whether a six-week nurse-led telephone education and counseling program could improve frailty and daily functioning in older adults living at home.
This single-center, two-arm, parallel-group randomized controlled trial included 122 adults aged 65 years or older who were frail or at risk of frailty and received home care services. Participants were randomly assigned to the intervention group or the usual care group, with 61 participants in each group.
Read more
Both groups continued to receive routine monthly home care. In addition, the intervention group received an initial face-to-face session followed by weekly telephone education and counseling sessions lasting approximately 20 to 25 minutes for six weeks. No additional intervention education or counseling was provided during weeks 7 to 18.
The primary outcome was frailty measured using the FRAIL Scale. Secondary outcomes included ability to perform instrumental activities of daily living, depressive symptoms, falls, emergency department visits, and hospitalizations. Frailty, daily functioning, and depressive symptoms were assessed at baseline, week 6, and week 18. Falls and health care use were recorded during the 18-week follow-up period. Outcome assessment and statistical analysis were conducted with treatment-group masking.
Read the detailed description
The study was conducted through a hospital-based home care unit in Kütahya, Türkiye.
The intervention was delivered by a nurse with a master's degree. It began with an individual face-to-face assessment and education session lasting approximately 20 to 25 minutes, followed by one telephone education and counseling session per week for six weeks. Each telephone session lasted approximately 20 to 25 minutes.
The program addressed frailty awareness, safe physical activity and mobility, nutrition and fluid intake, fall prevention and home safety, medication and chronic disease self-management, sleep and fatigue management, social support, and healthy daily routines. Education and counseling were individualized to participants' needs and supported by an educational booklet and an individual action plan. A standardized checklist was used to document delivery of the intervention content and completion of the sessions. No additional intervention education or counseling was provided during weeks 7 to 18.
Participants in both groups continued routine monthly hospital-based home care services, including assessment of general health, blood pressure, pulse, body temperature, and pressure injuries. Adverse events were monitored weekly in both groups. Reports of deaths were obtained from relatives and reviewed alongside available health records.
Face-to-face outcome assessments were performed at baseline, week 6, and week 18 by a researcher who was unaware of group allocation. Frailty was assessed with the FRAIL Scale, functional status with the Lawton-Brody Instrumental Activities of Daily Living Scale, and depressive symptoms with the 15-item Geriatric Depression Scale. Falls, emergency department visits, and hospitalizations were recorded during follow-up.
Randomization and statistical analysis were performed by different researchers. The statistical analyst received groups coded as A and B and remained unaware of the intervention and control labels during the main analyses. Measurements obtained before withdrawal or death were retained; no measurements were imputed after death.
- Conditions
- Frailty
- Being tested
- Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program
- Keywords
- Older adults, Telehealth, Nursing intervention, Frailty management, Functional status, Home care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Telehealth-Supported Multicomponent Frailty Management ProgramBehavioural
A six-week individualized education and counseling program delivered by a nurse with a master's degree. An initial face-to-face session and weekly telephone sessions each lasted approximately 20 to 25 minutes. Content addressed frailty awareness, safe physical activity and mobility, nutrition and fluid intake, fall prevention and home safety, medication and chronic disease self-management, sleep and fatigue management, social support, and healthy daily routines. An educational booklet and an individual action plan supported delivery. A standardized checklist documented session completion and content delivery. No additional intervention education or counseling was provided during weeks 7 to 18.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Telehealth-Supported Frailty Management Program | Experimental | Participants received a six-week nurse-led telehealth-supported frailty management program in addition to routine monthly home care. A nurse with a master's degree delivered an initial face-to-face assessment and education session, followed by weekly telephone education and counseling sessions lasting approximately 20 to 25 minutes. An educational booklet and an individual action plan supported the intervention. Session completion and content delivery were documented using a standardized checklist. No additional intervention education or counseling was provided during weeks 7 to 18. Receives: Behavioral: Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program |
| Usual Care | No intervention | Participants continued routine monthly hospital-based home care, including assessment of general health, blood pressure, pulse, body temperature, and pressure injuries. They did not receive the structured frailty education and telephone counseling program. Outcome assessments and weekly adverse event monitoring followed the same schedule as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, and 18 weeks
Secondary outcomes (5)
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.
Measured: Baseline, 6 weeks, and 18 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start5 Jun 2026
- Primary completion22 Oct 2026
- Study completion22 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a single-center, two-arm, parallel-group randomized superiority trial with 1:1 allocation. A computer-generated allocation sequence used fixed blocks of four and was prepared by a researcher distinct from the recruiter. The recruiter had no access to the allocation list and did not know the block size. Sequentially numbered, sealed opaque envelopes were opened after eligibility assessment and written informed consent, before baseline data collection. A total of 122 participants were randomized to the intervention or usual care group, with 61 participants in each group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634406
- Sponsor's protocol ID
- KSBU-FRAIL-RCT-2026-01
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the findings reported in the main publication, together with the associated data dictionary, will be made available to researchers upon reasonable request to the corresponding author for 5 years following publication of the main study article. The data will not be posted publicly to protect participant privacy. Access will be subject to applicable ethical and participant-consent requirements.
Publications
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.
PubMed 33402043Tarazona-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.
PubMed 26947059Fried 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.
PubMed 11253156
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07634406
- Acronym / sponsor ID
- KSBU-FRAIL-RCT-2026-01
- Conditions
- Frailty
- Keywords
- Older adults, Telehealth, Nursing intervention, Frailty management, Functional status, Home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 22 Oct 2026 (actual)
- Study completion
- 22 Oct 2026 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frailty can make older adults more vulnerable to loss of independence, falls, and hospitalization. This study evaluated whether a six-week nurse-led telephone education and counseling program could improve frailty and daily functioning in older adults living at home.
This single-center, two-arm, parallel-group randomized controlled trial included 122 adults aged 65 years or older who were frail or at risk of frailty and received home care services. Participants were randomly assigned to the intervention group or the usual care group, with 61 participants in each group.
Both groups continued to receive routine monthly home care. In addition, the intervention group received an initial face-to-face session followed by weekly telephone education and counseling sessions lasting approximately 20 to 25 minutes for six weeks. No additional intervention education or counseling was provided during weeks 7 to 18.
The primary outcome was frailty measured using the FRAIL Scale. Secondary outcomes included ability to perform instrumental activities of daily living, depressive symptoms, falls, emergency department visits, and hospitalizations. Frailty, daily functioning, and depressive symptoms were assessed at baseline, week 6, and week 18. Falls and health care use were recorded during the 18-week follow-up period. Outcome assessment and statistical analysis were conducted with treatment-group masking.
Detailed description
The study was conducted through a hospital-based home care unit in Kütahya, Türkiye.
The intervention was delivered by a nurse with a master's degree. It began with an individual face-to-face assessment and education session lasting approximately 20 to 25 minutes, followed by one telephone education and counseling session per week for six weeks. Each telephone session lasted approximately 20 to 25 minutes.
The program addressed frailty awareness, safe physical activity and mobility, nutrition and fluid intake, fall prevention and home safety, medication and chronic disease self-management, sleep and fatigue management, social support, and healthy daily routines. Education and counseling were individualized to participants' needs and supported by an educational booklet and an individual action plan. A standardized checklist was used to document delivery of the intervention content and completion of the sessions. No additional intervention education or counseling was provided during weeks 7 to 18.
Participants in both groups continued routine monthly hospital-based home care services, including assessment of general health, blood pressure, pulse, body temperature, and pressure injuries. Adverse events were monitored weekly in both groups. Reports of deaths were obtained from relatives and reviewed alongside available health records.
Face-to-face outcome assessments were performed at baseline, week 6, and week 18 by a researcher who was unaware of group allocation. Frailty was assessed with the FRAIL Scale, functional status with the Lawton-Brody Instrumental Activities of Daily Living Scale, and depressive symptoms with the 15-item Geriatric Depression Scale. Falls, emergency department visits, and hospitalizations were recorded during follow-up.
Randomization and statistical analysis were performed by different researchers. The statistical analyst received groups coded as A and B and remained unaware of the intervention and control labels during the main analyses. Measurements obtained before withdrawal or death were retained; no measurements were imputed after death.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This was a single-center, two-arm, parallel-group randomized superiority trial with 1:1 allocation. A computer-generated allocation sequence used fixed blocks of four and was prepared by a researcher distinct from the recruiter. The recruiter had no access to the allocation list and did not know the block size. Sequentially numbered, sealed opaque envelopes were opened after eligibility assessment and written informed consent, before baseline data collection. A total of 122 participants were randomized to the intervention or usual care group, with 61 participants in each group.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Telehealth-Supported Frailty Management Program | Experimental | Behavioral: Nurse-Led Telehealth-Supported Multicomponent Frailty Management ProgramParticipants received a six-week nurse-led telehealth-supported frailty management program in addition to routine monthly home care. A nurse with a master's degree delivered an initial face-to-face assessment and education session, followed by weekly telephone education and counseling sessions lasting approximately 20 to 25 minutes. An educational booklet and an individual action plan supported the intervention. Session completion and content delivery were documented using a standardized checklist. No additional intervention education or counseling was provided during weeks 7 to 18. |
| Usual Care | No intervention | –Participants continued routine monthly hospital-based home care, including assessment of general health, blood pressure, pulse, body temperature, and pressure injuries. They did not receive the structured frailty education and telephone counseling program. Outcome assessments and weekly adverse event monitoring followed the same schedule as in the intervention group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Telehealth-Supported Multicomponent Frailty Management ProgramA six-week individualized education and counseling program delivered by a nurse with a master's degree. An initial face-to-face session and weekly telephone sessions each lasted approximately 20 to 25 minutes. Content addressed frailty awareness, safe physical activity and mobility, nutrition and fluid intake, fall prevention and home safety, medication and chronic disease self-management, sleep and fatigue management, social support, and healthy daily routines. An educational booklet and an individual action plan supported delivery. A standardized checklist documented session completion and content delivery. No additional intervention education or counseling was provided during weeks 7 to 18. | Behavioural | Nurse-Led Telehealth-Supported Frailty Management Program |
Primary outcome
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.
5 secondary outcomes
Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale
Time frame: Baseline, 6 weeks, and 18 weeks
Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale
Time frame: Baseline, 6 weeks, and 18 weeks
Number of Falls During the Study Period
Time frame: From baseline to 18 weeks
Number of Emergency Department Visits During the Study Period
Time frame: From baseline to 18 weeks
Number of Hospitalizations During the Study Period
Time frame: From baseline to 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 33402043Esfandiari 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.
- Background: PubMed 26947059Tarazona-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.
- Background: PubMed 11253156Fried 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the findings reported in the main publication, together with the associated data dictionary, will be made available to researchers upon reasonable request to the corresponding author for 5 years following publication of the main study article. The data will not be posted publicly to protect participant privacy. Access will be subject to applicable ethical and participant-consent requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program in people with Frailty, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Level Assessed by the FRAIL Scale (time frame: Baseline, 6 weeks, and 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07634406, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.