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

16 de junio de 2026 actualizado 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)?

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

180

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Annakarin Olsson, Associate professor, PhD
  • Número de teléfono: 0046730552625
  • Correo electrónico: annakarin.olsson@hig.se

Copia de seguridad de contactos de estudio

  • Nombre: Maria Engström, Professor, PhD
  • Número de teléfono: 004626648215
  • Correo electrónico: maria.engstrom@hig.se

Ubicaciones de estudio

      • Gävle, Suecia
        • University of Gävle
        • Contacto:
          • Annakarin Olsson, Associate professor, PhD
          • Número de teléfono: 0046730552625
          • Correo electrónico: annakarin.olsson@hig.se
        • Contacto:
          • Maria Engström, Professor, PhD
          • Número de teléfono: 004626648215
          • Correo electrónico: maria.engstrom@hig.se

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Sin intervención: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Older peoples' rating of their health, well-being, and functional ability in everyday life.
Periodo de tiempo: [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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Older peoples' rating of their health/wellbeing
Periodo de tiempo: [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
Periodo de tiempo: [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
Periodo de tiempo: [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).]

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Older peoples' rating of their cognitive function
Periodo de tiempo: [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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de marzo de 2028

Finalización del estudio (Estimado)

31 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HIG-FORSK 2026/35

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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