Family FINGER: Lifestyle Intervention Among Older Caregivers
ConditionPositive Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTarja Välimäki
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
a multidomain lifestyle intervention
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Healthy Lifestyle InterventionExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline, 6 months, 12 months, and 18 monthsSecondary outcomes
1
Change from baseline in healthy lifestyle
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.
Time frame
Baseline, 12 months and 18 months2
Change from baseline in dementia risk (LIBRA score)
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.
Time frame
Baseline and 12 months3
Change from baseline in dementia risk (CAIDE score)
Cardiovascular Risk Factors, Aging and Dementia (CAIDE) score (range 0-15 points). Lower scores indicate lower dementia risk.
Time frame
Baseline and 12 months4
Change from baseline in cognitive function (MoCA score)
Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function.
Time frame
Baseline and 12 monthsOther outcomes
1
Feasibility (retention rate)
Proportion of randomized participants completing the 12-month assessment. Higher percentages indicate better retention.
Time frame
12 months2
Feasibility (qualitative evaluation)
Qualitative interviews assessing feasibility and acceptability of the intervention.
Time frame
Baseline and 12 months3
Change from baseline in objectively measured physical activity (Actigraph)
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.
Time frame
Baseline and 12 months4
Change from baseline in instrumental activities of daily living (IADL score)
Instrumental Activities of Daily Living (IADL) score (range 0-8). Higher scores indicate greater independence.
Time frame
Baseline, 12 months and 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tarja Välimäki
Lead sponsor
University of Eastern Finland
Sponsor institution
Tampere University
Collaborator
Karolinska Institutet
Collaborator
University of California, Davis
Collaborator
Finnish Institute for Health and Welfare
Collaborator
Carers Finland
Collaborator
Alzheimer Society of Finland
Collaborator
Source ClinicalTrials.gov