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Family FINGER: Lifestyle Intervention Among Older Caregivers

6 de julio de 2026 actualizado 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:

  1. What is the efficacy of the Family FINGER intervention on mental health?
  2. What is the efficacy of the Family FINGER intervention on secondary outcome measures: dementia risk, cognition, and lifestyles?

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

100

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: Tarja Välimäki, PhD
  • Número de teléfono: +358 40 355 2267
  • Correo electrónico: tarja.valimaki@uef.fi

Copia de seguridad de contactos de estudio

  • Nombre: Tiia Ngandu, MD, PhD
  • Número de teléfono: 0295247716
  • Correo electrónico: tiia.ngandu@thl.fi

Ubicaciones de estudio

  • Finlandia
      • Kuopio, Finlandia, 70210
        • Reclutamiento
        • Department of Nursing Science
        • Contacto:
          • Tarja Välimäki, PhD
          • Número de teléfono: +358 40 355 2267
          • Correo electrónico: tarja.valimaki@uef.fi
        • Investigador principal:
          • Tarja Välimäki, PhD
        • Investigador principal:
          • Tiia Ngandu, MD, PhD

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

Sí

Descripción

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.

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Cuidado estándar
Experimental: Healthy Lifestyle Intervention
Conductual: a multidomain 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.
Otros nombres:
  • Family FINGER

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Periodo de tiempo: 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.
Baseline, 6 months, 12 months, and 18 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in healthy lifestyle
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Change from baseline in cognitive function (MoCA score)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Baseline and 12 months
Number of moderate-to-vigorous physical activity sessions per week. Higher values indicate greater physical activity.
Baseline and 12 months
Change from baseline in physical activity
Periodo de tiempo: Baseline and 12 months
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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility (retention rate)
Periodo de tiempo: 12 months
Proportion of randomized participants completing the 12-month assessment. Higher percentages indicate better retention.
12 months
Feasibility (qualitative evaluation)
Periodo de tiempo: Baseline and 12 months
Qualitative interviews assessing feasibility and acceptability of the intervention.
Baseline and 12 months
Change from baseline in objectively measured physical activity (Actigraph)
Periodo de tiempo: 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
Change from baseline in instrumental activities of daily living (IADL score)
Periodo de tiempo: 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
Change from baseline in activities of daily living (Barthel Index score)
Periodo de tiempo: 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
Change from baseline in physical performance (SPPB score)
Periodo de tiempo: Baseline and 12 months
Short Physical Performance Battery (SPPB) total score (range 0-12). Higher scores indicate better lower extremity function.
Baseline and 12 months
Change from baseline in hand-grip strength (kg)
Periodo de tiempo: Baseline and 12 months
Hand-grip strength measured using a dynamometer. Higher values indicate greater muscle strength.
Baseline and 12 months
Number of falls
Periodo de tiempo: 12 months
Total number of falls recorded using a falls diary.
12 months
Change from baseline in cortisol levels
Periodo de tiempo: Baseline and 12 months
Cortisol concentration measured from hair samples (pg/mg). Lower levels indicate better outcome.
Baseline and 12 months
Change from baseline in systolic blood pressure, mmHg.
Periodo de tiempo: Baseline and 12 months
Lower systolic blood pressure indicates a better outcome.
Baseline and 12 months
Change from baseline in diastolic blood pressure, mmHg.
Periodo de tiempo: 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.
Periodo de tiempo: Baseline and 12 months
Lower BMI value indicates a better outcome.
Baseline and 12 months
Change from baseline in waist circumference, cm.
Periodo de tiempo: Baseline and 12 months
Lower value indicates a better outcome.
Baseline and 12 months
Change from baseline in blood lipids - Total Cholesterol, mmol/L.
Periodo de tiempo: Baseline and 12 months
Measured from serum with lower cholesterol value indicating a better outcome.
Baseline and 12 months
Change from baseline in blood lipids - HDL Cholesterol, mmol/L.
Periodo de tiempo: Baseline and 12 months
Measured from serum with higher HDL cholesterol value indicating a better outcome.
Baseline and 12 months
Change from baseline in blood lipids - LDL Cholesterol, mmol/L.
Periodo de tiempo: 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.
Periodo de tiempo: Baseline and 12 months
Measured from serum with lower triglycerides value indicating a better outcome.
Baseline and 12 months
Change from baseline in glycated haemoglobin (HbA1c), %
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Baseline and 12 months
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
Baseline and 12 months
Change from baseline in physical functioning - Timed Up and Go (TUG)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Change from baseline in social well-being - Experiences of Social Inclusion Scale
Periodo de tiempo: 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
Change from baseline in health-related quality of life - RAND-36 Health Survey
Periodo de tiempo: Baseline and 12 months
The scale values are ranging 0-100, with higher scores indicating a better outcome.
Baseline and 12 months
Change from baseline in stress-related symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Change from baseline in depressive symptoms
Periodo de tiempo: Baseline and 12 months
Geriatric Depression Scale (GDS). Values ranging 0-15, with lower scores indicating a better outcome.
Baseline and 12 months
Change from baseline in nutrition - Mini-Nutritional Assessment (MNA)
Periodo de tiempo: Baseline and 12 months
Mini Nutritional Assessment (0-14). Higher scores indicate better nutritional status.
Baseline and 12 months
Change from baseline in nutrition - Global Leadership Initiative on Malnutrition (GLIM) criteria
Periodo de tiempo: Baseline and 12 months
Categorical classification (no malnutrition / moderate / severe).
Baseline and 12 months
Comorbidity (Functional Comorbidity Index score)
Periodo de tiempo: 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

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

Patrocinador

Tarja Välimäki

Colaboradores

Karolinska Institutet
University of California, Davis
Tampere University
Finnish Institute for Health and Welfare
Carers Finland
Alzheimer Society of Finland

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)

22 de junio de 2026

Finalización primaria (Estimado)

30 de abril de 2028

Finalización del estudio (Estimado)

30 de abril de 2028

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

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

6 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 6/13.00/2026
  • 362628 (Otro identificador: Research Council of Finland)
  • 362706 (Otro identificador: Research Council of Finland)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

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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