Brain health in very old people, long-term time trends and associated social and health-related factors – the Gerontological Database study

ISRCTN ISRCTN14955279
DOI https://doi.org/10.1186/ISRCTN14955279
Submission date
23/04/2025
Registration date
28/04/2025
Last edited
25/04/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
As people live longer, dementia and depression are affecting an increasing number of those aged 85 years and older. The risk of brain-related health conditions, such as dementia and depression, rises with age, posing a threat to overall health and well-being while also placing significant strain on societal and healthcare systems. However, most research has focused on younger, healthier groups, leaving many questions about brain health among the oldest adults unanswered. This project aims to study brain health in very old adults living in Västerbotten (Sweden), Österbotten (Finland), and Åland (Finland). This project will investigate cognitive function (how one thinks and remembers things) and mental well-being (how one feels emotionally), as well as various factors that might affect these aspects of health.

Who can participate?
People aged 85, 90, and 95 years and older living in Umeå, Malå, Sorsele, Storuman, Vilhelmina and Dorotea in Sweden, and those aged 85, 90 or 95 years and older living in Vaasa, Korsholm, Malax, Korsnäs or the Åland islands in Finland.

What does the study involve?
A trained assessor will visit participants at home, including aged care facilities, to conduct structured interviews and assessments. The interview consists of questions pertaining to social relationships, health and mood, and the assessments include, but are not limited to, cognitive tests, vision and hearing tests, gait speed evaluations and physical assessments such as blood pressure measurements and capillary blood tests.

What are the possible benefits and risks of participating?
The benefits of participating in the study include contributing towards research aiming to promote the health and quality of life of very old adults, as well as potentially gaining increased insight into one’s own health status. As the study population consists of older adults, many of whom may be vulnerable, there is a risk of psychological distress when participating in the study. This risk has been minimized by providing contact details to the research team, including medical doctors, who will provide support and referrals as necessary.

Where is the study run from?
Umeå University (Sweden)

When is the study starting and how long is it expected to run for?
Sepetember 2023 to December 2030

Who is funding the study?
1. Demensfonden (Sweden)
2. BAS-ALF medel (Region Västerbotten) (Sweden)

Who is the main contact?
Prof.r Birgitta Olofsson, birgitta.olofsson@umu.se

Study website

Contact information

Prof Birgitta Olofsson
Public, Scientific, Principal Investigator

Department Of Nursing, Umeå University
Umeå
901 87
Sweden

Phone +46 (0)706616463
Email birgitta.olofsson@umu.se

Study information

Study designObservational study (longitudinal and cross-sectional)
Primary study designObservational
Secondary study designLongitudinal and cross-sectional
Study setting(s)Care home, Home, Medical and other records
Study typeDiagnostic, Other, Prevention, Quality of life, Screening, Treatment, Safety, Efficacy
Participant information sheet Not available in web format, please use contact details to request a participation information
Scientific titleBiopsychosocial correlates, regional variations and long-term trends of brain health in very old adults, the BRAIN HEALTH project
Study acronymGERDA= GERontological DAtabase
Study objectivesExplore brain health by investigating cognitive functioning and mental well-being in very old adults (aged 85-, 90-, and ≥95-year) including prevalence, interconnections, long-term temporal trends, associated social and health-related factors and blood biomarkers, in three Nordic regions (Västerbotten, Sweden; Österbotten, Finland and Åland, Finland).
Ethics approval(s)

1. Approved 19/03/2025, Swedish Ethical Review Authority (Box 2110, Uppsala, 750 02, Sweden; +46 (0)10 475 08 00; registrator@etikprovning.se), ref: Dnr 2025-01089-01

2. Not yet submitted, Ethics committee name not provided (Address not provided, Wasa, Zip/postal code not provided, Finland; Telephone number not provided; Email not provided), ref: Reference number not provided

3. Not yet submitted, Ethics committee name not provided (Address not provided, Mariehamn, Zip/postal code not provided, Åland Islands; Telephone number not provided; Email not provided), ref: Reference number not provided

Health condition(s) or problem(s) studiedParticipants' health and well-being, living conditions, etc, are studied in relation to brain health (cognitive function and mental well-being)
InterventionHome visits will be conducted using structured interviews with validated assessments in 2025-2027 in Umeå and five rural municipalities in Västerbotten, in Vasa and three rural municipalities in Osterbotten and Åland. Assessors will receive comprehensive training and supervision to ensure consistency and data quality. Interviews will take place at participants’ homes, residential care facilities, or, if preferred, in a clinic or hospital. Additional interviews with next of kin and caregivers, along with medical record reviews (when approved), will complement the assessments. This approach ensures participation regardless of physical or cognitive impairments and maintains high data quality.
Intervention typeOther
Primary outcome measure1. Dementia disorders measured using the Mini Mental State Examination (MMSE), the Frontal Assessment Battery (FAB), and the Organic Brain Scale (OBS) during the home visits
2. Depressive disorders measured using the Geriatric Depression Scale 15-item version (GDS-15), the Life Orientation Scale (LOS), the Philadelphia Geriatric Center Morale Scale (PGCMS), the Hospital Anxiety and Depression Scale (HAD) and the Organic Brain Syndrome Scale (OBS) during the home visits

Measured at home visits in 2000/2002 and every 5 years (except in 2020/2022 due to the COVID-19 pandemic) until 2025/2027
Secondary outcome measures1. Health-related factors measured using self-rated health, the Mini Nutritional Assessment (MNA), the Global Leadership Initiative on Malnutrition (GLIM) criteria, the Katz Activities of Daily Living (KATZ-ADL) staircase (Personal and Instrumental ADL), the BARTHEL ADL index, the International Physical Activity Questionnaire Expanded Version (IPAQE-80+), the Frändin Grimby activity scale (summer/winter), and by collecting data on diseases, medications, hospitalization, vision, hearing, pain, sleep, tobacco, alcohol, dizziness, biomarkers and immunomarkers, different aids, outdoor activities, 30 sec chair stand test, gait speed, handgrip (isometric handgrip strength), body composition, height, weight, blood pressure, pulse, oral health, dental status, falls and fear of falling during the home visits
2. Psychosocial factors measured by collecting data on leisure activities, social interactions, loneliness, number of contacts, informal caregiving, pets, inner strength, life crises, ageism, safety, and digital technology use during the home visits

Measured at home visits in 2000/2002 and every 5 years (except in 2020/2022 due to the COVID-19 pandemic) until 2025/2027
Overall study start date01/09/2023
Completion date31/12/2030

Eligibility

Participant type(s)Population, Other
Age groupSenior
Lower age limit85 Years
Upper age limit120 Years
SexBoth
Target number of participantsIn Sweden about 700 and Finland about 500
Key inclusion criteria1. Being 85 years old, 90 years old or 95 years or older
2. Living in the municipality of Umeå (Sweden 2025-2026), Vasa (+ three municipalities in Österbotten) and Åland (Finland 2025-2026) and five rural municipalities in Sweden (Sorsele, Malå, Storuman, Vilhelmina and Dorotea) in 2027
Key exclusion criteriaDoes not meet the inclusion criteria
Date of first enrolment30/04/2025
Date of final enrolment31/12/2027

Locations

Countries of recruitment

  • Finland
  • Sweden
  • Åland Islands

Study participating centres

Department of Nursing
Umeå Universitet
Umeå
901 87
Sweden
Ab Yrkeshögskolan vid Åbo Akademi/Yrkeshögskolan Novia
Wolffskavägen 33
Vasa
652 00
Finland
Högskolan på Åland
PB 1010
Mariehamn
221 11
Åland Islands

Sponsor information

Umeå University
University/education

Department Of Nursing
Umeå
901 87
Sweden

Phone +46 (0)907865000
Email forskning.omvardnad@umu.se
Website https://www.umu.se/en/department-of-nursing/
ROR logo "ROR" https://ror.org/05kb8h459

Funders

Funder type

Charity

Demensfonden
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Dementia Fund, Stiftelsen Demensfonden
Location
Sweden
BAS ALF-medel (Region Västerbotten)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe maintain a dedicated homepage (https://www.gerdacenter.com/) where we continuously update the progress of our project. This serves as a central platform for stakeholders and researchers to stay informed about our activities and findings. In addition to updating the website, we issue press releases in local and/or national media to announce major findings and events.

Our aim is to publish our research findings in highly ranked international peer-reviewed journals (at least eight articles). This ensures that our work undergoes rigorous scrutiny and reaches a global audience, contributing to advancing knowledge in our field. We actively participate in national and international conferences where we present our research findings to fellow academics, professionals, and stakeholders. This platform enables us to engage in discussions, receive feedback, and forge collaborations with others in the field. We also support the development of two dissertations based on the project, one at Umeå University and one at Åbo Akademi University. To effectively reach policymakers, we publish a policy brief in the project's final year, which will be presented to a broad audience, including policymakers and politicians. The policy brief will be uploaded to the GERDA website and communicated in local media.
IPD sharing planThe project involves sensitive data from the Gerontological Regional Database (GERDA) and newly collected datasets. In compliance with legal and ethical standards, including the GDPR and Biobank Act, all data will be pseudonymized, encrypted, and stored in access-controlled environments. Personal identifiers will be removed before data access is granted. Pseudonymized data will only be shared upon request and under strict protocols, ensuring that only authorized researchers can access it. All reported findings will be presented in aggregate form to prevent individual identification. Metadata will be published at researchdata.se according to FAIR principles through the Swedish National Data Service (SND), enabling future research and ensuring transparency.

Editorial Notes

25/04/2025: Study's existence confirmed by the Swedish Ethical Review Authority.