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NCT Number: NCT07627386

Family FINGER: Lifestyle Intervention 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?

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Key information

Conditions

Positive Mental Health

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nursing Science

Kuopio, 70210, Finland

Location status: Recruiting

Location contact

Tarja Välimäki, PhD

CONTACT

[email protected]

+358 40 355 2267

Tarja Välimäki, PhD

PRINCIPAL_INVESTIGATOR

Tiia Ngandu, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a multidomain lifestyle intervention

Behavioral

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.

Other names: Family FINGER

Primary outcomes

  1. Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

    Time frame: 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.

Secondary outcomes

  1. Change from baseline in healthy lifestyle

    Time frame: 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.

  2. Change from baseline in dementia risk (LIBRA score)

    Time frame: 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.

  3. Change from baseline in dementia risk (CAIDE score)

    Time frame: Baseline and 12 months

    Cardiovascular Risk Factors, Aging and Dementia (CAIDE) score (range 0-15 points). Lower scores indicate lower dementia risk.

  4. Change from baseline in cognitive function (MoCA score)

    Time frame: Baseline and 12 months

    Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function.

  5. Change from baseline in dietary intake

    Time frame: Baseline and 12 months

    Dietary quality assessed using the adapted FINGER Diet Index (range 0-9). Higher scores indicate better adherence to dietary recommendations.

  6. Change from baseline in physical activity frequency (sessions/week)

    Time frame: Baseline and 12 months

    Number of moderate-to-vigorous physical activity sessions per week. Higher values indicate greater physical activity.

  7. Change from baseline in physical activity

    Time frame: 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.

Other outcomes

  1. Feasibility (retention rate)

    Time frame: 12 months

    Proportion of randomized participants completing the 12-month assessment. Higher percentages indicate better retention.

  2. Feasibility (qualitative evaluation)

    Time frame: Baseline and 12 months

    Qualitative interviews assessing feasibility and acceptability of the intervention.

  3. Change from baseline in objectively measured physical activity (Actigraph)

    Time frame: 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.

  4. Change from baseline in instrumental activities of daily living (IADL score)

    Time frame: Baseline, 12 months and 18 months

    Instrumental Activities of Daily Living (IADL) score (range 0-8). Higher scores indicate greater independence.

  5. Change from baseline in activities of daily living (Barthel Index score)

    Time frame: Baseline, 12 months and 18 months

    Barthel Index score (range 0-100). Higher scores indicate greater independence in daily activities.

  6. Change from baseline in physical performance (SPPB score)

    Time frame: Baseline and 12 months

    Short Physical Performance Battery (SPPB) total score (range 0-12). Higher scores indicate better lower extremity function.

  7. Change from baseline in hand-grip strength (kg)

    Time frame: Baseline and 12 months

    Hand-grip strength measured using a dynamometer. Higher values indicate greater muscle strength.

  8. Number of falls

    Time frame: 12 months

    Total number of falls recorded using a falls diary.

  9. Change from baseline in cortisol levels

    Time frame: Baseline and 12 months

    Cortisol concentration measured from hair samples (pg/mg). Lower levels indicate better outcome.

  10. Change from baseline in systolic blood pressure, mmHg.

    Time frame: Baseline and 12 months

    Lower systolic blood pressure indicates a better outcome.

  11. Change from baseline in diastolic blood pressure, mmHg.

    Time frame: Baseline and 12 months

    Lower diastolic blood pressure indicates a better outcome.

  12. Change from baseline in Body Mass Index (BMI), kg/m2.

    Time frame: Baseline and 12 months

    Lower BMI value indicates a better outcome.

  13. Change from baseline in waist circumference, cm.

    Time frame: Baseline and 12 months

    Lower value indicates a better outcome.

  14. Change from baseline in blood lipids - Total Cholesterol, mmol/L.

    Time frame: Baseline and 12 months

    Measured from serum with lower cholesterol value indicating a better outcome.

  15. Change from baseline in blood lipids - HDL Cholesterol, mmol/L.

    Time frame: Baseline and 12 months

    Measured from serum with higher HDL cholesterol value indicating a better outcome.

  16. Change from baseline in blood lipids - LDL Cholesterol, mmol/L.

    Time frame: Baseline and 12 months

    Measured from serum with lower cholesterol value indicating a better outcome.

  17. Change from baseline in blood triglycerides, mmol/L.

    Time frame: Baseline and 12 months

    Measured from serum with lower triglycerides value indicating a better outcome.

  18. Change from baseline in glycated haemoglobin (HbA1c), %

    Time frame: Baseline and 12 months

    Measured from fasting blood sample, with lower HbA1c value indicating a better outcome.

  19. Complete blood count (CBC)

    Time frame: Baseline and 12 months

    Complete blood count measured from blood samples, including hemoglobin, leukocyte count, and platelet count.

  20. Change from baseline in S-hsCRP (mg/l)

    Time frame: Baseline and 12 months

    Measured from serum with lower values indicating a better outcome.

  21. Change from baseline in physical functioning - Activities-specific Balance Confidence (ABC) Scale

    Time frame: Baseline and 12 months

    Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.

  22. Change from baseline in physical functioning - Timed Up and Go (TUG)

    Time frame: Baseline and 12 months

    Time required to complete the Timed Up and Go test. Lower values indicate better mobility.

  23. Change from baseline in physical functioning - Frailty (Fried's phenotype)

    Time frame: Baseline and 12 months

    Frailty score based on five criteria (range 0-5). Lower scores indicate less frailty.

  24. Change from baseline in quality of life - Care-related Quality of Life instrument (CarerQol)

    Time frame: 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.

  25. Change from baseline in social well-being - Experiences of Social Inclusion Scale

    Time frame: 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.

  26. Change from baseline in health-related quality of life - RAND-36 Health Survey

    Time frame: Baseline and 12 months

    The scale values are ranging 0-100, with higher scores indicating a better outcome.

  27. Change from baseline in stress-related symptoms

    Time frame: Baseline and 12 months

    Perceived Stress Scale (PSS-10). Values ranging 0-40, with lower scores indicating a better outcome.

  28. Change from baseline in depressive symptoms

    Time frame: Baseline and 12 months

    Center for Epidemiological Studies Depression scale. Values ranging 0-60, with lower scores indicating a better outcome.

  29. Change from baseline in depressive symptoms

    Time frame: Baseline and 12 months

    Geriatric Depression Scale (GDS). Values ranging 0-15, with lower scores indicating a better outcome.

  30. Change from baseline in nutrition - Mini-Nutritional Assessment (MNA)

    Time frame: Baseline and 12 months

    Mini Nutritional Assessment (0-14). Higher scores indicate better nutritional status.

  31. Change from baseline in nutrition - Global Leadership Initiative on Malnutrition (GLIM) criteria

    Time frame: Baseline and 12 months

    Categorical classification (no malnutrition / moderate / severe).

  32. Comorbidity (Functional Comorbidity Index score)

    Time frame: Baseline and 12 months

    List of diseases. Measured as counts. A lower number of diseases indicates a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Tarja Välimäki, PhD

CONTACT

[email protected]

+358 40 355 2267

Tiia Ngandu, MD, PhD

CONTACT

[email protected]

0295247716

Sponsors and collaborators

Lead sponsor

Tarja Välimäki

Other

Collaborators

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

Registry information

Official study title

Family FINGER: a Pilot Randomised Controlled Trial of Healthy Lifestyle Intervention Versus Standard Care Among Older Caregivers

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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