Positive Mental Health
Conditions
Keywords
family care, caregiver, lifestyle intervention, positive mental health, older adults
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. 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?
Detailed description
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.
Interventions
BEHAVIORALa 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.
Sponsors
Tarja Välimäki
Tampere University
Karolinska Institutet
University of California, Davis
Finnish Institute for Health and Welfare
Carers Finland
Alzheimer Society of Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomised, controlled, parallel-group, single-centre pilot trial testing the effect of the multidomain Family FINGER intervention on positive mental health versus standard care.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in healthy lifestyle | 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. |
| Change from baseline in dementia risk (LIBRA score) | 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. |
| Change from baseline in dementia risk (CAIDE score) | Baseline and 12 months | Cardiovascular Risk Factors, Aging and Dementia (CAIDE) score (range 0-15 points). Lower scores indicate lower dementia risk. |
| Change from baseline in cognitive function (MoCA score) | Baseline and 12 months | Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function. |
| Change from baseline in dietary intake | Baseline and 12 months | Dietary quality assessed using the adapted FINGER Diet Index (range 0-9). Higher scores indicate better adherence to dietary recommendations. |
| Change from baseline in physical activity frequency (sessions/week) | Baseline and 12 months | Number of moderate-to-vigorous physical activity sessions per week. Higher values indicate greater physical activity. |
| Change from baseline in physical activity | 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. |
Countries
Finland
Contacts
CONTACTTarja Välimäki, PhD
CONTACTTiia Ngandu, MD, PhD
Outcome results
None listed