Family FINGER: Lifestyle Intervention Among Older Caregivers

NCT07627386 | Not Yet Recruiting

• 3 other identifiers: 6/13.00/2026362628362706
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Positive Mental Health

Keywords

family care; caregiver; lifestyle intervention; positive mental health; older adults

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (7)

• Change from baseline in healthy lifestyle

  Baseline, 12 months and 18 months

• Change from baseline in dementia risk (LIBRA score)

  Baseline and 12 months

• Change from baseline in dementia risk (CAIDE score)

  Baseline and 12 months

• Change from baseline in cognitive function (MoCA score)

  Baseline and 12 months

• Change from baseline in dietary intake

  Baseline and 12 months

Other Outcomes (32)

• Feasibility (retention rate)

  12 months

• Feasibility (qualitative evaluation)

  Baseline and 12 months

• Change from baseline in objectively measured physical activity (Actigraph)

  Baseline and 12 months

Study Arms (2)

Healthy Lifestyle Intervention

EXPERIMENTAL

Behavioral: a multidomain lifestyle intervention

Standard Care

NO INTERVENTION

Interventions

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.

Also known as: Family FINGER

Healthy Lifestyle Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarja Välimäki: lead
• Tampere University: collaborator
• University of California, Davis: collaborator
• Carers Finland: collaborator
• Alzheimer Society of Finland: collaborator
• Karolinska Institutet: collaborator
• Finnish Institute for Health and Welfare: collaborator

Study Sites (1)

Department of Nursing Science

Kuopio, 70210, Finland

Location

Central Study Contacts

Tarja Välimäki, PhD

CONTACT

+358 40 355 2267; tarja.valimaki@uef.fi

Tiia Ngandu, MD, PhD

CONTACT

0295247716; tiia.ngandu@thl.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be actively told to what group they have been assigned (intervention or control). Primary outcome assessors will be blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomised, controlled, parallel-group, single-centre pilot trial testing the effect of the multidomain Family FINGER intervention on positive mental health versus standard care.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 4, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)