Family FINGER: Lifestyle Intervention Among Older Caregivers

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?

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.

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.