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HEalthy Aging Team Supported Home-care Services (HEAT-YASAM) (HEAT-YASAM)

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ClinicalTrials.gov Identifier: NCT05993572
Recruitment Status : Enrolling by invitation
First Posted : August 15, 2023
Last Update Posted : December 6, 2023
Sponsor:
Collaborator:
Provincial Health Services Authority
Information provided by (Responsible Party):
Bilal Katipoglu, Gulhane Training and Research Hospital

Study Description
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Brief 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 individuals and to determine possible changes in the follow-up of the patients during the 2-year follow-up period. (HEAVEN trial)

Condition or disease Intervention/treatment
Frailty Dementia Depression Malnutrition Old Age; Debility Drug Use Diagnostic Test: Comprehensive Geriatric Assessment

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Does Healthy Aging Team-supported Home-care Services Pilot Program Reduce ED Visits? A Prospective before-and After-intervention Study
Actual Study Start Date : June 15, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Comprehensive Geriatric Assessment
    Comprehensive Geriatric Assessments include functional status, fraility comorbidity, cognition, mental health, social support, nutrition, and geriatric syndromes

Outcome Measures
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Primary Outcome Measures :
  1. Short term Healthy Aging status (mortality) [ Time Frame: 1-,3-,6- month ]
    Outcomes were evaluated according to the national electronic database.

  2. 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)

  3. 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).

  4. 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).

  5. 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)

  6. 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)

  7. 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).

  8. Long term Healthy Aging status (mortality) [ Time Frame: 1- and 2- year ]
    Outcomes were evaluated according to the national electronic database.

  9. 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)

  10. 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.)

  11. 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).

  12. 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).

  13. 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).

  14. 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).


Eligibility Criteria
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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 80 years and over older adults
  • individuals giving verbal and written consent for the YASAM project

Exclusion Criteria:

  • <80 years older adults
  • those who did not give verbal and written consent for the YASAM project
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05993572


Locations
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Turkey
Balikesir Ataturk City Hospital
Balikesir, None Selected, Turkey, 10100
Sponsors and Collaborators
Gulhane Training and Research Hospital
Provincial Health Services Authority
Investigators
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Study Director: Bilal Katipoglu Gulhane Training and Research Hospital
More Information
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Responsible Party: Bilal Katipoglu, Associate Professor, Gulhane Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05993572    
Other Study ID Numbers: 2023-3-24
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Frailty
Pathologic Processes
Nutrition Disorders