FrailtyHEAT-YASAMNCT05993572
HEalthy Aging Team Supported Home-care Services (HEAT-YASAM)
An observational study of Frailty and Dementia, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Depending on the YASAM project which was established to home-visit evaluate community-dwelling older adults (80 years of age and over), we aimed to determine the prevalence (prevalence) of geriatric syndromes (dependence, frailty, malnutrition, depression, dementia, comorbidity burden, polypharmacy) in these… Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Dementia, Depression
- What is being tested?
- Comprehensive Geriatric Assessment
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 1 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: It is planned to include a total of 6000 individuals in the first phase, which is carried out in 20 centers throughout the province of Balıkesir (rural and central area) and whose coordination center is Balikesir Atatürk City Hospital. In the follow-ups, it is planned to include the whole cohort consisting of individuals over the age of 40 thousand 80, by increasing the number of teams.
Who may be able to join
- 80 years and over older adults
- individuals giving verbal and written consent for the YASAM project
Who cannot join
- <80 years older adults
- those who did not give verbal and written consent for the YASAM project
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir Ataturk City Hospital
Balıkesir, None Selected, 10100
About this study
Official title: Does Healthy Aging Team-supported Home-care Services Pilot Program Reduce ED Visits? A Prospective before-and After-intervention Study
Depending on the YASAM project which was established to home-visit evaluate community-dwelling older adults (80 years of age and over), we aimed to determine the prevalence (prevalence) of geriatric syndromes (dependence, frailty, malnutrition, depression, dementia, comorbidity burden, polypharmacy) in these individuals and to determine possible changes in the follow-up of the patients during the 2-year follow-up period. (HEAVEN trial)
Read the detailed description
Individuals over the age of 80 who will participate in the YASAM project will first be informed by phone and their appointments will be made. Subsequently, a home visit will be conducted after obtaining verbal and written consent from the patients and their relatives.
The chronic diseases and medications of the patients will be questioned and controlled from the electronic data set. To determine the level of frailty and dependency, the Katz, Lawton-Brody, and Clinical Frailty scales will be filled in, respectively, by the previously trained health personnel, by interviewing their relatives. Mini-Cog, Mini Mental Status Assessment, Mini Nutrition Assessment, and Geriatric Depression (Yesavage) Assessments will be planned. According to dependency status, individuals will be re-evaluated in the 1st or 2nd month. If the patients are fully independent, control follow-up is planned in the 3rd month. Written file records will be created by obtaining the consent of the patients and their relatives at each patient visit. Each team will be responsible for the follow-up of 300 patients. It is planned to include a total of 6000 individuals in the first phase, which is carried out in 20 centers throughout the province of Balıkesir and whose coordination center is Atatürk city hospital. In the follow-ups, it is planned to include the whole cohort consisting of 40 thousand individuals over the age of 80, by increasing the number of teams. The short-term results of the patient's follow-up (1st, 3rd, and 6th-month results), changes in mortality, addiction, frailty level, and changes in nutrition and cognitive functions within the specified period will be evaluated as short-term results. It is aimed to record the long-term outcomes (1st and 2nd year) of the same variables.
Since the whole population will be included in the study, sample size and power analysis were not performed.
- Conditions
- Frailty, Dementia, Depression, Malnutrition, Old Age; Debility, Drug Use
- Being tested
- Comprehensive Geriatric Assessment
- Medical subject headings
- Frailty, Dementia, Depression, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentDiagnostic test
Comprehensive Geriatric Assessments include functional status, fraility comorbidity, cognition, mental health, social support, nutrition, and geriatric syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term Healthy Aging status (mortality)
Outcomes were evaluated according to the national electronic database.
Measured: 1-,3-,6- month
Short term Healthy Aging status (changes dependency )
Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)
Measured: 1-,3-,6- month
Short term Healthy Aging status (changes in frailty level)
Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome).
Measured: 1-,3-,6- month
Short term Healthy Aging status (changes in nutrition)
Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 0 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).
Measured: 1-,3-,6- month
Short term Healthy Aging status (changes in cognitive functions)
Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome)
Measured: 1-,3-,6- month
Short term Healthy Aging status (changes in mood)
Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test ( Yesavage for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome)
Measured: 1-,3-,6- month
Short term Healthy Aging status (changes in mobility status)
Outcomes were evaluated according to the specific test (Chair stand test higher scores (>13,5 seconds) means a worse outcome for mobility status).
Measured: 1-,3-,6- month
Long term Healthy Aging status (mortality)
Outcomes were evaluated according to the national electronic database.
Measured: 1- and 2- year
Long term Healthy Aging status (changes dependency )
Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)
Measured: 1- and 2- year
Long term Healthy Aging status (changes in frailty level)
Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome.)
Measured: 1- and 2- year
Long term Healthy Aging status (changes in nutrition)
Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 1 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).
Measured: 1- and 2- year
Long term Healthy Aging status (changes in cognitive functions)
Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome).
Measured: 1- and 2- year
Long term Healthy Aging status (changes in mood)
Outcomes were evaluated according to the specific test ( Yesavage scale for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome).
Measured: 1- and 2- year
Long term Healthy Aging status (changes in mobility status)
Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test (Chair stand test higher scores (>13,5 seconds) means a worse outcome for mobility status).
Measured: 1- and 2- year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Jun 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Provincial Health Services Authority British Columbia
- Responsible party
- Principal investigator, Bilal Katipoglu, Gulhane Training and Research Hospital
- Investigators
- Bilal Katipoglu, Study director, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993572
- Sponsor's protocol ID
- 2023-3-24
- Acronym
- HEAT-YASAM
- Status last verified
- Nov 2023
- First submitted
- 21 Jul 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Katipoglu B, Kocyigit SE, Ergun U, Kocak AO, Aydeniz O, Mert I, Keskin SK. A Community-Based Integrated Healthy Aging Program at a Tertiary Hospital (YASAM) for the Oldest Old Participants May have the Potential to Reduce Emergency Admission: Preliminary Evidence from a Pre-Post-Intervention Study. J Emerg Med. 2025 May;72:112-120. doi: 10.1016/j.jemermed.2024.12.009. Epub 2024 Dec 31.
PubMed 40316458Katipoglu B, Kocyigit SE. Impact of geriatric syndrome burden on healthcare services utilization and mortality among community-dwelling older adults: is it still too late to do something? Eur Geriatr Med. 2025 Jun;16(3):1055-1061. doi: 10.1007/s41999-025-01189-w. Epub 2025 Mar 22.
PubMed 40120075
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Healthy Aging Team-supported Home-care Services Pilot Program Reduce ED Visits? A Prospective before-and After-intervention Study
- ClinicalTrials.gov ID
- NCT05993572
- Acronym / sponsor ID
- HEAT-YASAM / 2023-3-24
- Conditions
- Frailty, Dementia, Depression, Malnutrition, Old Age; Debility, Drug Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Collaborators
- Provincial Health Services Authority British Columbia
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
Depending on the YASAM project which was established to home-visit evaluate community-dwelling older adults (80 years of age and over), we aimed to determine the prevalence (prevalence) of geriatric syndromes (dependence, frailty, malnutrition, depression, dementia, comorbidity burden, polypharmacy) in these individuals and to determine possible changes in the follow-up of the patients during the 2-year follow-up period. (HEAVEN trial)
Detailed description
Individuals over the age of 80 who will participate in the YASAM project will first be informed by phone and their appointments will be made. Subsequently, a home visit will be conducted after obtaining verbal and written consent from the patients and their relatives.
The chronic diseases and medications of the patients will be questioned and controlled from the electronic data set. To determine the level of frailty and dependency, the Katz, Lawton-Brody, and Clinical Frailty scales will be filled in, respectively, by the previously trained health personnel, by interviewing their relatives. Mini-Cog, Mini Mental Status Assessment, Mini Nutrition Assessment, and Geriatric Depression (Yesavage) Assessments will be planned. According to dependency status, individuals will be re-evaluated in the 1st or 2nd month. If the patients are fully independent, control follow-up is planned in the 3rd month. Written file records will be created by obtaining the consent of the patients and their relatives at each patient visit. Each team will be responsible for the follow-up of 300 patients. It is planned to include a total of 6000 individuals in the first phase, which is carried out in 20 centers throughout the province of Balıkesir and whose coordination center is Atatürk city hospital. In the follow-ups, it is planned to include the whole cohort consisting of 40 thousand individuals over the age of 80, by increasing the number of teams. The short-term results of the patient's follow-up (1st, 3rd, and 6th-month results), changes in mortality, addiction, frailty level, and changes in nutrition and cognitive functions within the specified period will be evaluated as short-term results. It is aimed to record the long-term outcomes (1st and 2nd year) of the same variables.
Since the whole population will be included in the study, sample size and power analysis were not performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- It is planned to include a total of 6000 individuals in the first phase, which is carried out in 20 centers throughout the province of Balıkesir (rural and central area) and whose coordination center is Balikesir Atatürk City Hospital. In the follow-ups, it is planned to include the whole cohort consisting of individuals over the age of 40 thousand 80, by increasing the number of teams.
Key inclusion criteria (2 listed)
- 80 years and over older adults
- individuals giving verbal and written consent for the YASAM project
Key exclusion criteria (2 listed)
- <80 years older adults
- those who did not give verbal and written consent for the YASAM project
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 |
|---|---|---|
| Comprehensive Geriatric AssessmentComprehensive Geriatric Assessments include functional status, fraility comorbidity, cognition, mental health, social support, nutrition, and geriatric syndromes | Diagnostic test | – |
Primary outcome
Short term Healthy Aging status (mortality)
Time frame: 1-,3-,6- month
Outcomes were evaluated according to the national electronic database.
Short term Healthy Aging status (changes dependency )
Time frame: 1-,3-,6- month
Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)
Short term Healthy Aging status (changes in frailty level)
Time frame: 1-,3-,6- month
Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome).
Short term Healthy Aging status (changes in nutrition)
Time frame: 1-,3-,6- month
Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 0 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).
Short term Healthy Aging status (changes in cognitive functions)
Time frame: 1-,3-,6- month
Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome)
Short term Healthy Aging status (changes in mood)
Time frame: 1-,3-,6- month
Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test ( Yesavage for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome)
Short term Healthy Aging status (changes in mobility status)
Time frame: 1-,3-,6- month
Outcomes were evaluated according to the specific test (Chair stand test higher scores (>13,5 seconds) means a worse outcome for mobility status).
Long term Healthy Aging status (mortality)
Time frame: 1- and 2- year
Outcomes were evaluated according to the national electronic database.
Long term Healthy Aging status (changes dependency )
Time frame: 1- and 2- year
Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)
Long term Healthy Aging status (changes in frailty level)
Time frame: 1- and 2- year
Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome.)
Long term Healthy Aging status (changes in nutrition)
Time frame: 1- and 2- year
Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 1 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).
Long term Healthy Aging status (changes in cognitive functions)
Time frame: 1- and 2- year
Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome).
Long term Healthy Aging status (changes in mood)
Time frame: 1- and 2- year
Outcomes were evaluated according to the specific test ( Yesavage scale for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome).
Long term Healthy Aging status (changes in mobility status)
Time frame: 1- and 2- year
Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test (Chair stand test higher scores (>13,5 seconds) means a worse outcome for mobility status).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 40316458Katipoglu B, Kocyigit SE, Ergun U, Kocak AO, Aydeniz O, Mert I, Keskin SK. A Community-Based Integrated Healthy Aging Program at a Tertiary Hospital (YASAM) for the Oldest Old Participants May have the Potential to Reduce Emergency Admission: Preliminary Evidence from a Pre-Post-Intervention Study. J Emerg Med. 2025 May;72:112-120. doi: 10.1016/j.jemermed.2024.12.009. Epub 2024 Dec 31.
- Derived from this study: PubMed 40120075Katipoglu B, Kocyigit SE. Impact of geriatric syndrome burden on healthcare services utilization and mortality among community-dwelling older adults: is it still too late to do something? Eur Geriatr Med. 2025 Jun;16(3):1055-1061. doi: 10.1007/s41999-025-01189-w. Epub 2025 Mar 22.
- Individual participant dataSharing planned: Undecided
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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.
Bilal Katipoglu study director
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Dementia, run by Gulhane Training and Research Hospital 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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?
Results are not available in the source record.
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?
Short term Healthy Aging status (mortality) (time frame: 1-,3-,6- month). The study lists 14 primary outcomes in all. 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 NCT05993572, which also lists 2 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 6 Dec 2023.