- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07661472
The FINGER Model - Preventing Cognitive Decline and Promoting Health of Older People.
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.
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)?
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Annakarin Olsson, Associate professor, PhD
- Phone Number: 0046730552625
- Email: annakarin.olsson@hig.se
Study Contact Backup
- Name: Maria Engström, Professor, PhD
- Phone Number: 004626648215
- Email: maria.engstrom@hig.se
Study Locations
-
-
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Gävle, Sweden
- University of Gävle
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Contact:
- Annakarin Olsson, Associate professor, PhD
- Phone Number: 0046730552625
- Email: annakarin.olsson@hig.se
-
Contact:
- Maria Engström, Professor, PhD
- Phone Number: 004626648215
- Email: maria.engstrom@hig.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Brain Group
The FINGER model, based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors:
|
The FINGER model, based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors:
|
|
No Intervention: The Brain Fellowship
The 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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).]
|
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.
|
[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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Older peoples' rating of their health/wellbeing
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).]
|
Survey, scale for health EUROQOL VISUAL ANALOGUE SCALE (EQ-VAS), scores 0-100, higher scores better health.
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[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).]
|
|
Older peoples' rating of their health/wellbeing - Loneliness
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).]
|
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).
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[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).]
|
|
Older peoples' rating of their health/wellbeing - Depression and anxiety
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).]
|
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").
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[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).]
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Older peoples' rating of their cognitive function
Time Frame: [Time Frame: Data collection at baseline (T(time)0, before)) intervention and 6 months after T0 (T3).]
|
Clock test, The person draws the clock face themselves, and then adds the numbers and hands. The time shown by the hands should be 10 minutes past 11. Different scoring methods have been described. One common way of scoring is 0-4 points, as follows:
|
[Time Frame: Data collection at baseline (T(time)0, before)) intervention and 6 months after T0 (T3).]
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Annakarin Olsson, Associate professor, PhD, University of Gävle
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIG-FORSK 2026/35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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