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Older PeopleNCT07661472

The FINGER Model - Preventing Cognitive Decline and Promoting Health of Older People.

A study testing FINGER model in people with Older People, run by University of Gavle at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Cognitive impairment and dementia can cause considerable suffering, both for the person affected and for next of kin. They also pose major challenges for health and social care. At the same time, research shows that many risk factors for cognitive decline can, in fact, be influenced. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Older People
What is being tested?
FINGER model
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSweden
Study dates
1 Jun 2026to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • older person is 65 years or older, registered as a resident in Bollnäs Municipality, and responds to questions about lifestyle habits, well-being, memory, and cardiovascular diseases. Participants must also be able to take responsibility for their own transport to and from physical meetings, have access to their own digital device, such as a smartphone, computer, or iPad, and have the time and opportunity to attend weekly sessions over a period of nine months. For participation in the research study, participants must also be able to take part in an interview in Swedish, complete a questionnaire, and provide informed consent. For participants who are only included in the questionnaire-based part of the study, the criteria are the ability to complete a questionnaire and provide informed consent.

Who cannot join

  • if the person has cognitive impairment or dementia to such an extent that an interview is not considered possible or ethically appropriate, has pronounced communication difficulties that make an interview impossible, and/or requires an interpreter.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Annakarin Olsson, Associate professor, PhD contact

0046730552625

annakarin.olsson@hig.se

Maria Engström, Professor, PhD contact

004626648215

maria.engstrom@hig.se

Sweden1 site
  • University of Gävle

    Gävle

    Annakarin Olsson, Associate professor, PhD, 0046730552625, annakarin.olsson@hig.se

    Maria Engström, Professor, PhD, 004626648215, maria.engstrom@hig.se

Other trials in Sweden

About this study

Official title: The FINGER Model for Preventing Cognitive Decline and Promoting Health - Older Peoples' Perspectives on Participating in the Projects "Hjärngänget" and "Hjärncellskapet" - a Pathway to Better Health.

Cognitive impairment and dementia can cause considerable suffering, both for the person affected and for next of kin. They also pose major challenges for health and social care. At the same time, research shows that many risk factors for cognitive decline can, in fact, be influenced. This is particularly the case when several areas are addressed simultaneously, such as physical activity, healthy eating habits, mental stimulation, social connectedness, and good cardiovascular health. A well-known model for such a multidomain preventive intervention is the FINGER model: the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability. In the randomized controlled FINGER study, the results showed that a two-year programme comprising diet, exercise, cognitive training, social activity, and structured monitoring of vascular risk factors could improve and maintain cognitive function among older people at increased risk of cognitive decline. However, the research evidence is not unequivocal. Other randomized studies found no effect on cognitive outcomes over three years in the studied population, and in a cluster-randomized study reported no clear effects on the incidence of dementia in the older population. In addition, studies are needed that follow changes when the model is implemented in clinical practice. In recent years, the FINGER model has also been adapted and tested in several countries through the FINGER network, with the aim of developing and evaluating interventions that work in different contexts, while also strengthening knowledge and enabling comparisons of results between countries. A recently published qualitative study showed that participants were often motivated by an expectation of personal benefit, both for brain health and physical health, but also by concerns about cognitive decline. Social aspects also played an important role, as did the need for the interventions to feel understandable and for lifestyle changes to be perceived as realistic and feasible in everyday life.

The overall aim of the project is to evaluate a municipality-initiated, health-promoting multicomponent programme, based on the FINGER model, for older people, with a focus on health, health-related quality of life, well-being, and lifestyle habits (group A), and to compare it with a programme with fewer components (group B) implemented in the municipality. Furthermore, the aim is to explore older people's experiences of participating in the project, as well as how older people in the study rate their health and well-being before, during, and after completing their participation in the project.

Read more

The main research questions are:

  • How do older people rate their health, health-related quality of life, well-being, and lifestyle habits before, during, and after participation in the municipality's project (groups A and B)?
  • What cognitive and physical functional ability do older people have before, during, and after participation in the municipality's project (group A)?
  • Are there any differences over time within each group (A and B), and are there any differences over time between the groups in the project?
  • Do self-rated health and health-related quality of life in this study population differ from the values reported in a previously published study?
  • How do older people experience participating in the project (group A)?
Read the detailed description

Quasi-experimental design with two groups (A and B), including baseline measurements (T0) and follow-up measurements (T1-T3), as well as a descriptive qualitative interview study in group A (the FINGER model).

Group A*, referred to by the municipality as "Hjärngänget": The municipality's project, which is inspired by the FINGER model, is based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors. This part is carried out entirely by the municipality, on its own initiative regardless of whether research is conducted or not, and is not influenced in any way by the researchers. A more detailed description of the programme for group A is provided below:

Physical activity: one instructor-led group exercise session per week and one individual exercise session per week, a lecture on physical activity and brain health, and individual programme planning.

Cognitive training: home-based training three times per week for approximately 15 minutes, two practical workshops, and a lecture on cognitive training and brain health.

Diet: a lecture on diet and two practical workshops. Social interaction: a coffee/social gathering in connection with the group exercise session, as well as support in finding associations and activities.

Cardiovascular health: blood sampling and health checks at the start and end of the programme, as well as a lecture on cardiovascular health, including oral health, hearing, and vision.

Supportive counselling: advisory health conversations and three individual sessions with a health educator focusing on behaviour change and motivation.

Group B*, referred to by the municipality as "Hjärncellskapet": Group B will be recruited from the same target population, through the same channels and using the same selection criteria, but will receive a less extensive intervention. Group B will be offered participation in five lectures related to the five FINGER components.

The selection of participants for group A will comprise approximately 15 people who are assessed as having the highest number of risk factors for cognitive decline. Others who have expressed interest will be invited to participate in group B. In addition to the municipality's inclusion criteria, the research study requires that participants in group A are able to take part in an interview in Swedish, complete a questionnaire, and provide informed consent. For group B, participants must be able to complete a questionnaire and provide informed consent. FINGER model, group A: round 1, approximately 15 participants (2026); round 2, approximately 15 participants (2027); and round 3, approximately 15 participants (2027). Group B: round 1, approximately 55 participants (2026); round 2, approximately 40 participants (2027); and round 3, approximately 40 participants (2027).

Data analysis: Quantitative data will be analyzed using descriptive statistics and analytical statistics. Effects between groups will be analyzed using ANCOVA and, where appropriate, GEE. Comparisons with published reference data will be conducted using one-sample t-tests. For non-normally distributed data, corresponding non-parametric methods will be used. Analyses will be performed in IBM SPSS Statistics. Interview data will be analyzed using qualitative inductive content analysis. The analysis aims to identify categories that describe experiences of participation, involvement, barriers and facilitators, and perceived meaning.

Conditions
Older People
Being tested
FINGER model
Keywords
Physical activity, Health, health-related quality of life, well-being, lifestyle habits, cognitive and physical functional ability
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FINGER modelOther

    The FINGER model, based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors:

    • Physical activity: one instructor-led group exercise session per week and one individual exercise session per week, a lecture on physical activity and brain health, and individual programme planning.
    • Cognitive training: home-based training three times per week for approximately 15 minutes, two practical workshops, and a lecture on cognitive training and brain health.
    • Diet: a lecture on diet and two practical workshops.
    • Social interaction: a social gathering in connection with the group exercise session, as well as support in finding associations and activities.
    • Cardiovascular health: blood sampling and health checks at the start and end of the programme, as well as a lecture on cardiovascular health, including oral health, hearing, and vision
    • Supportive counselling
Study groups in NCT07661472
Study groupRoleWhat they receive
The Brain GroupExperimentalThe FINGER model, based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors: * Physical activity: one instructor-led group exercise session per week and one individual exercise session per week, a lecture on physical activity and brain health, and individual programme planning. * Cognitive training: home-based training three times per week for approximately 15 minutes, two practical workshops, and a lecture on cognitive training and brain health. * Diet: a lecture on diet and two practical workshops. * Social interaction: a social gathering in connection with the group exercise session, as well as support in finding associations and activities. * Cardiovascular health: blood sampling and health checks at the start and end of the programme, as well as a lecture on cardiovascular health, including oral health, hearing, and vision * Supportive counselling
Receives: Other: FINGER model
The Brain FellowshipNo interventionThe Brain Fellowship (group B) will be offered participation in five lectures related to the five FINGER components (physical activity, cognitive training, diet, social interaction and supportive counselling).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Older peoples' rating of their health, well-being, and functional ability in everyday life.

    Survey, RAND-36 with 8 dimensions: Physical Function, Role Physical, Role mental, Vitality, Mental Health, Social Function, Bodily Pain, and General Health with scores 0-100, higher scores a more desirable outcome for wellbeing.

    Measured: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

Secondary outcomes (3)
  1. Older peoples' rating of their health/wellbeing

    Survey, scale for health EUROQOL VISUAL ANALOGUE SCALE (EQ-VAS), scores 0-100, higher scores better health.

    Measured: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

  2. Older peoples' rating of their health/wellbeing - Loneliness

    The UCLA 3-item loneliness scale will be used to measure loneliness. Higher scores indicating more loneliness. Each item rated on a 3-popint scale 1)hardly ever 2) some of the time, 3) often. Total score of the scale is the sum of the three items ( scale range 3-9).

    Measured: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

  3. Older peoples' rating of their health/wellbeing - Depression and anxiety

    Survey, the Patient Health Questionnaire PHQ-4 will be used that gives a score for nervous, worried or stressed, not being able to stop worrying or control your worries, little interest or joy of doing things and felt low, depressed, or experienced feelings of hopelessness, scored between 0-3, higher score more depressive symptoms, each item rated from 0 ( "not at all") to 3 ( "nearly every day").

    Measured: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07661472
Sponsor's protocol ID
HIG-FORSK 2026/35
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data set with individual data are not available to share due to general data protection regulations (GDPR), and in line with the ethics application.

Publications

  • Shulman KI. Clock-drawing: is it the ideal cognitive screening test? Int J Geriatr Psychiatry. 2000 Jun;15(6):548-61. doi: 10.1002/1099-1166(200006)15:63.0.co;2-u.

    PubMed 10861923
  • Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

    PubMed 18504506
  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777
  • Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

    PubMed 8275167
  • Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

    PubMed 14769454

Questions about this trial

What is this clinical trial studying?

A study testing FINGER model in people with Older People, run by University of Gavle at 1 site in Sweden.

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Jun 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 Sweden. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annakarin Olsson, Associate professor, PhD (0046730552625, annakarin.olsson@hig.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Older peoples' rating of their health, well-being, and functional ability in everyday life. (time frame: [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]). 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 NCT07661472, which also lists 5 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 22 Jun 2026.

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