Family FINGER: Lifestyle Intervention Among Older Caregivers
6 de julho de 2026 atualizado por: Tarja Välimäki
Family FINGER: a Pilot Randomised Controlled Trial of Healthy Lifestyle Intervention Versus Standard Care Among Older Caregivers
The Family FINGER study enrolls caregivers aged 65 or older who live with and care for a spouse with cognitive impairment in North Savo, Finland (estimated n=100). This intervention builds on the FINGER study, which showed improved cognitive performance and health benefits, including better health-related quality of life. The intervention will be tailored to meet caregivers' specific needs.
The overall aim of the Family FINGER trial is to assess the efficacy of this intervention on the positive mental health of spousal caregivers.
Specific research questions are as follows:
- What is the efficacy of the Family FINGER intervention on mental health?
- What is the efficacy of the Family FINGER intervention on secondary outcome measures: dementia risk, cognition, and lifestyles?
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
Background:
This study applies the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) intervention model among family caregivers.
Study design:
Randomised, controlled, parallel-group, single-centre pilot trial testing the efficacy of the multidomain Family FINGER lifestyle intervention on positive mental health versus standard care.
Recruitment:
Up to 100 spousal family caregivers aged 65 and older who are caring for a spouse with cognitive impairment and live in the same household will be recruited from Northern Savo, Finland. Interested participants will be screened for eligibility. Eligible participants will undergo baseline assessments and will be randomised 1:1 to either the Family FINGER intervention (intervention group) or standard care (control group).
The aim and outcomes:
The primary aim of the Family FINGER trial is to test a multimodal lifestyle intervention and evaluate its effect on positive mental health. Primary comparison time point for positive mental health is at 12 months.
Secondary outcomes will focus on broader effects, including dementia risk and cognitive functioning, and various assessments of lifestyle, diet, physical activity, cognitive and social activities. In addition, the trial will assess factors including stress levels, general health, depressive symptoms, social inclusion, and quality of life. Medical history, health status, and nutrition will also be evaluated.
Furthermore, anthropometric measurements and other lifestyle-related dementia risk factors such as smoking, alcohol consumption, cholesterol levels, HbA1c, physical activity, and performance will be considered. Other assessments include feasibility (i.e., recruitment rate, retention, intervention adherence) and qualitative interviews.
Intervention:
The intervention includes physical activities, social activities, cognitive training, cardiovascular risk management, and nutritional guidance. The dietary intervention will be based on Finnish national guidelines and include individual and group visits. The exercise intervention includes at least weekly supervised and independent aerobic, strength, and balance training. The training will be progressive in resistance level, duration, and frequency. Cognitive training includes individual and/or group-based sessions and independent digital cognitive training. Vascular risk management intervention includes assessment and consultation regarding diet, blood pressure, blood lipids, glucose levels, body weight, smoking, and alcohol consumption. All interventions will be delivered by trained study staff. Interventions are tailored according to the participant's health status and/or functional limitations, and both in-person and remote options are considered for intervention delivery.
Tipo de estudo
Intervencional
Inscrição (Estimado)
100
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: Tarja Välimäki, PhD
- Número de telefone: +358 40 355 2267
- E-mail: tarja.valimaki@uef.fi
Estude backup de contato
- Nome: Tiia Ngandu, MD, PhD
- Número de telefone: 0295247716
- E-mail: tiia.ngandu@thl.fi
Locais de estudo
-
-
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Kuopio, Finlândia, 70210
- Recrutamento
- Department of Nursing Science
-
Contato:
- Tarja Välimäki, PhD
- Número de telefone: +358 40 355 2267
- E-mail: tarja.valimaki@uef.fi
-
Investigador principal:
- Tarja Välimäki, PhD
-
Investigador principal:
- Tiia Ngandu, MD, PhD
-
-
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
Sim
Descrição
Inclusion Criteria:
- Aged 65 and older.
- Caregiver for a spouse with cognitive impairment.
- Live in the same household with the care recipient.
- The presence of modifiable risk factors for health: at least one self-reported lifestyle-related risk factor, or self-reported CAIDE dementia risk scores of 6 or higher, or a self-reported burdensome caregiving situation.
Exclusion Criteria:
- A medication for Alzheimer's disease or diagnosis of dementia or suspected dementia (such as referral to or ongoing assessment process at memory clinic, or MoCa < 18 points).
- Any health condition affecting safe engagement in the intervention, or the caregiving situation is such that specialised social or health care services are needed before safe engagement in the intervention can be ensured, according to clinical judgement.
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: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Cuidados Padrão
|
|
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Experimental: Healthy Lifestyle Intervention
|
The intervention includes physical activities, social activities, cognitive training, cardiovascular health management, and dietary guidance.
The exercise intervention includes at least weekly supervised and independent training in aerobic, strength, and balance exercises, along with social activities.
The training will be progressive in resistance level, duration, and frequency.
Cognitive training encompasses individual and/or group-based sessions, as well as independent digital cognitive training.
Vascular risk management interventions include assessments and consultations regarding blood pressure, blood lipids, glucose levels, body weight, smoking, and alcohol consumption.
The dietary intervention will be based on national guidelines and include individual and group visits.
All interventions will be delivered by trained study staff.
Interventions are tailored according to the participant's health status, caregiving situation, and/or functional limitations.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Primary comparison at 12-months with extended 6-month follow-up.
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Baseline, 6 months, 12 months, and 18 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in healthy lifestyle
Prazo: Baseline, 12 months and 18 months
|
Composite Healthy Lifestyle Index score (range 0-24), including diet, physical activity, smoking, alcohol use, and cognitive/social activities.
Higher scores indicate a healthier lifestyle.
Primary comparison at 12-months with extended 6-month follow-up.
|
Baseline, 12 months and 18 months
|
|
Change from baseline in dementia risk (LIBRA score)
Prazo: Baseline and 12 months
|
Lifestyle for Brain Health (LIBRA) index score (theoretical range -5.9 to +12.7).
Lower scores indicate a healthy lifestyle and lower estimated dementia risk.
|
Baseline and 12 months
|
|
Change from baseline in dementia risk (CAIDE score)
Prazo: Baseline and 12 months
|
Cardiovascular Risk Factors, Aging and Dementia (CAIDE) score (range 0-15 points).
Lower scores indicate lower dementia risk.
|
Baseline and 12 months
|
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Change from baseline in cognitive function (MoCA score)
Prazo: Baseline and 12 months
|
Montreal Cognitive Assessment (MoCA) total score (range 0-30).
Higher scores indicate better cognitive function.
|
Baseline and 12 months
|
|
Change from baseline in dietary intake
Prazo: Baseline and 12 months
|
Dietary quality assessed using the adapted FINGER Diet Index (range 0-9).
Higher scores indicate better adherence to dietary recommendations.
|
Baseline and 12 months
|
|
Change from baseline in physical activity frequency (sessions/week)
Prazo: Baseline and 12 months
|
Number of moderate-to-vigorous physical activity sessions per week.
Higher values indicate greater physical activity.
|
Baseline and 12 months
|
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Change from baseline in physical activity
Prazo: Baseline and 12 months
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Self-reported physical exercise in the previous two weeks, using a modified version of the Minnesota Leisure Time Physical Activity Questionnaire, expressed as total duration of physical activity (minutes/week).
Higher levels of physical activity indicate a better outcome.
|
Baseline and 12 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility (retention rate)
Prazo: 12 months
|
Proportion of randomized participants completing the 12-month assessment.
Higher percentages indicate better retention.
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12 months
|
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Feasibility (qualitative evaluation)
Prazo: Baseline and 12 months
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Qualitative interviews assessing feasibility and acceptability of the intervention.
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Baseline and 12 months
|
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Change from baseline in objectively measured physical activity (Actigraph)
Prazo: Baseline and 12 months
|
Physical activity measured using a wrist-worn accelerometer over 7 consecutive days, reported as time spent in physical activity (e.g., minutes/day).
Higher values indicate greater physical activity.
|
Baseline and 12 months
|
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Change from baseline in instrumental activities of daily living (IADL score)
Prazo: Baseline, 12 months and 18 months
|
Instrumental Activities of Daily Living (IADL) score (range 0-8).
Higher scores indicate greater independence.
|
Baseline, 12 months and 18 months
|
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Change from baseline in activities of daily living (Barthel Index score)
Prazo: Baseline, 12 months and 18 months
|
Barthel Index score (range 0-100).
Higher scores indicate greater independence in daily activities.
|
Baseline, 12 months and 18 months
|
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Change from baseline in physical performance (SPPB score)
Prazo: Baseline and 12 months
|
Short Physical Performance Battery (SPPB) total score (range 0-12).
Higher scores indicate better lower extremity function.
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Baseline and 12 months
|
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Change from baseline in hand-grip strength (kg)
Prazo: Baseline and 12 months
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Hand-grip strength measured using a dynamometer.
Higher values indicate greater muscle strength.
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Baseline and 12 months
|
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Number of falls
Prazo: 12 months
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Total number of falls recorded using a falls diary.
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12 months
|
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Change from baseline in cortisol levels
Prazo: Baseline and 12 months
|
Cortisol concentration measured from hair samples (pg/mg).
Lower levels indicate better outcome.
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Baseline and 12 months
|
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Change from baseline in systolic blood pressure, mmHg.
Prazo: Baseline and 12 months
|
Lower systolic blood pressure indicates a better outcome.
|
Baseline and 12 months
|
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Change from baseline in diastolic blood pressure, mmHg.
Prazo: Baseline and 12 months
|
Lower diastolic blood pressure indicates a better outcome.
|
Baseline and 12 months
|
|
Change from baseline in Body Mass Index (BMI), kg/m2.
Prazo: Baseline and 12 months
|
Lower BMI value indicates a better outcome.
|
Baseline and 12 months
|
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Change from baseline in waist circumference, cm.
Prazo: Baseline and 12 months
|
Lower value indicates a better outcome.
|
Baseline and 12 months
|
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Change from baseline in blood lipids - Total Cholesterol, mmol/L.
Prazo: Baseline and 12 months
|
Measured from serum with lower cholesterol value indicating a better outcome.
|
Baseline and 12 months
|
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Change from baseline in blood lipids - HDL Cholesterol, mmol/L.
Prazo: Baseline and 12 months
|
Measured from serum with higher HDL cholesterol value indicating a better outcome.
|
Baseline and 12 months
|
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Change from baseline in blood lipids - LDL Cholesterol, mmol/L.
Prazo: Baseline and 12 months
|
Measured from serum with lower cholesterol value indicating a better outcome.
|
Baseline and 12 months
|
|
Change from baseline in blood triglycerides, mmol/L.
Prazo: Baseline and 12 months
|
Measured from serum with lower triglycerides value indicating a better outcome.
|
Baseline and 12 months
|
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Change from baseline in glycated haemoglobin (HbA1c), %
Prazo: Baseline and 12 months
|
Measured from fasting blood sample, with lower HbA1c value indicating a better outcome.
|
Baseline and 12 months
|
|
Complete blood count (CBC)
Prazo: Baseline and 12 months
|
Complete blood count measured from blood samples, including hemoglobin, leukocyte count, and platelet count.
|
Baseline and 12 months
|
|
Change from baseline in S-hsCRP (mg/l)
Prazo: Baseline and 12 months
|
Measured from serum with lower values indicating a better outcome.
|
Baseline and 12 months
|
|
Change from baseline in physical functioning - Activities-specific Balance Confidence (ABC) Scale
Prazo: Baseline and 12 months
|
Activities-specific Balance Confidence (ABC) Scale (0-100%).
Higher scores indicate greater confidence.
|
Baseline and 12 months
|
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Change from baseline in physical functioning - Timed Up and Go (TUG)
Prazo: Baseline and 12 months
|
Time required to complete the Timed Up and Go test.
Lower values indicate better mobility.
|
Baseline and 12 months
|
|
Change from baseline in physical functioning - Frailty (Fried's phenotype)
Prazo: Baseline and 12 months
|
Frailty score based on five criteria (range 0-5).
Lower scores indicate less frailty.
|
Baseline and 12 months
|
|
Change from baseline in quality of life - Care-related Quality of Life instrument (CarerQol)
Prazo: Baseline, 12 months and 18 months
|
The answers from Care-related Quality of Life instrument (CarerQol) are transformed into a single index score ranging from 0 (worst possible care situation) to 100 (best possible care situation).
Higher scores indicate better care-related quality of life.
Primary comparison at 12-months with extended 6-month follow-up.
|
Baseline, 12 months and 18 months
|
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Change from baseline in social well-being - Experiences of Social Inclusion Scale
Prazo: Baseline, 12 months and 18 months
|
The score ranges from 10 to 50, yielding a raw sum score, which is then converted to a scale of 0 to 100, with higher scores indicating greater social inclusion.
Primary comparison at 12-months with extended 6-month follow-up.
|
Baseline, 12 months and 18 months
|
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Change from baseline in health-related quality of life - RAND-36 Health Survey
Prazo: Baseline and 12 months
|
The scale values are ranging 0-100, with higher scores indicating a better outcome.
|
Baseline and 12 months
|
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Change from baseline in stress-related symptoms
Prazo: Baseline and 12 months
|
Perceived Stress Scale (PSS-10).
Values ranging 0-40, with lower scores indicating a better outcome.
|
Baseline and 12 months
|
|
Change from baseline in depressive symptoms
Prazo: Baseline and 12 months
|
Center for Epidemiological Studies Depression scale.
Values ranging 0-60, with lower scores indicating a better outcome.
|
Baseline and 12 months
|
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Change from baseline in depressive symptoms
Prazo: Baseline and 12 months
|
Geriatric Depression Scale (GDS).
Values ranging 0-15, with lower scores indicating a better outcome.
|
Baseline and 12 months
|
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Change from baseline in nutrition - Mini-Nutritional Assessment (MNA)
Prazo: Baseline and 12 months
|
Mini Nutritional Assessment (0-14).
Higher scores indicate better nutritional status.
|
Baseline and 12 months
|
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Change from baseline in nutrition - Global Leadership Initiative on Malnutrition (GLIM) criteria
Prazo: Baseline and 12 months
|
Categorical classification (no malnutrition / moderate / severe).
|
Baseline and 12 months
|
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Comorbidity (Functional Comorbidity Index score)
Prazo: Baseline and 12 months
|
List of diseases.
Measured as counts.
A lower number of diseases indicates a better outcome.
|
Baseline and 12 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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)
22 de junho de 2026
Conclusão Primária (Estimado)
30 de abril de 2028
Conclusão do estudo (Estimado)
30 de abril de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
15 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de maio de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 6/13.00/2026
- 362628 (Outro identificador: Research Council of Finland)
- 362706 (Outro identificador: Research Council of Finland)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The Family FINGER Trial Steering Group is open to requests from external researchers for data collected in this study.
Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required.
The Family FINGER Trial Steering Group will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing Family FINGER analyses, and other matters) on a case-by-case basis and provide the data or reject the request.
Shared data will encompass the data dictionary and de-identified data only.
Any analysis will be conducted in collaboration with the Family FINGER Trial Steering Group.
Access is subject to the applicable legal framework.
An access agreement will be prepared and signed by both parties.
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
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