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

16 de junho de 2026 atualizado por: Annakarin Olsson, University of Gavle

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)?

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

180

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Annakarin Olsson, Associate professor, PhD
  • Número de telefone: 0046730552625
  • E-mail: annakarin.olsson@hig.se

Estude backup de contato

Locais de estudo

      • Gävle, Suécia
        • University of Gävle
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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:

  • 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

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
Sem intervenção: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Older peoples' rating of their health, well-being, and functional ability in everyday life.
Prazo: [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).]

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Older peoples' rating of their health/wellbeing
Prazo: [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.
[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
Prazo: [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).
[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
Prazo: [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").
[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).]

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Older peoples' rating of their cognitive function
Prazo: [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:

  • Draws a clock face in the form of a closed circle: 1 point
  • Places the numbers in the correct positions: 1 point
  • Includes all 12 correct numbers: 1 point
  • Places the hands in the correct positions: 1 point A person with normal cognitive function should be able to draw the clock without difficulty and receive 4 points. Clinical judgement must be applied, but a low score, lower than 4, indicates the need for further assessment.
[Time Frame: Data collection at baseline (T(time)0, before)) intervention and 6 months after T0 (T3).]

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Annakarin Olsson, Associate professor, PhD, University of Gävle

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

31 de março de 2028

Conclusão do estudo (Estimado)

31 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

16 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • HIG-FORSK 2026/35

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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