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:
- What is the efficacy of the Family FINGER intervention on mental health?
- What is the efficacy of the Family FINGER intervention on secondary outcome measures: dementia risk, cognition, and lifestyles?
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tarja Välimäki, PhD
- 電話番号：+358 40 355 2267
- メール：tarja.valimaki@uef.fi
研究連絡先のバックアップ
- 名前：Tiia Ngandu, MD, PhD
- 電話番号：0295247716
- メール：tiia.ngandu@thl.fi
研究場所
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Kuopio、フィンランド、70210
- 募集
- Department of Nursing Science
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コンタクト：
- Tarja Välimäki, PhD
- 電話番号：+358 40 355 2267
- メール：tarja.valimaki@uef.fi
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主任研究者：
- Tarja Välimäki, PhD
-
主任研究者：
- Tiia Ngandu, MD, PhD
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-
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：標準ケア
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実験的：Healthy Lifestyle Intervention
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
時間枠：Baseline, 6 months, 12 months, and 18 months
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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.
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Baseline, 6 months, 12 months, and 18 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in healthy lifestyle
時間枠：Baseline, 12 months and 18 months
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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.
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Baseline, 12 months and 18 months
|
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Change from baseline in dementia risk (LIBRA score)
時間枠：Baseline and 12 months
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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.
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Baseline and 12 months
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Change from baseline in dementia risk (CAIDE score)
時間枠：Baseline and 12 months
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Cardiovascular Risk Factors, Aging and Dementia (CAIDE) score (range 0-15 points).
Lower scores indicate lower dementia risk.
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Baseline and 12 months
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Change from baseline in cognitive function (MoCA score)
時間枠：Baseline and 12 months
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Montreal Cognitive Assessment (MoCA) total score (range 0-30).
Higher scores indicate better cognitive function.
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Baseline and 12 months
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Change from baseline in dietary intake
時間枠：Baseline and 12 months
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Dietary quality assessed using the adapted FINGER Diet Index (range 0-9).
Higher scores indicate better adherence to dietary recommendations.
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Baseline and 12 months
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Change from baseline in physical activity frequency (sessions/week)
時間枠：Baseline and 12 months
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Number of moderate-to-vigorous physical activity sessions per week.
Higher values indicate greater physical activity.
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Baseline and 12 months
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Change from baseline in physical activity
時間枠：Baseline and 12 months
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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.
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Baseline and 12 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility (retention rate)
時間枠：12 months
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Proportion of randomized participants completing the 12-month assessment.
Higher percentages indicate better retention.
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12 months
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Feasibility (qualitative evaluation)
時間枠：Baseline and 12 months
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Qualitative interviews assessing feasibility and acceptability of the intervention.
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Baseline and 12 months
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Change from baseline in objectively measured physical activity (Actigraph)
時間枠：Baseline and 12 months
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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.
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Baseline and 12 months
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Change from baseline in instrumental activities of daily living (IADL score)
時間枠：Baseline, 12 months and 18 months
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Instrumental Activities of Daily Living (IADL) score (range 0-8).
Higher scores indicate greater independence.
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Baseline, 12 months and 18 months
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Change from baseline in activities of daily living (Barthel Index score)
時間枠：Baseline, 12 months and 18 months
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Barthel Index score (range 0-100).
Higher scores indicate greater independence in daily activities.
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Baseline, 12 months and 18 months
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Change from baseline in physical performance (SPPB score)
時間枠：Baseline and 12 months
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Short Physical Performance Battery (SPPB) total score (range 0-12).
Higher scores indicate better lower extremity function.
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Baseline and 12 months
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Change from baseline in hand-grip strength (kg)
時間枠：Baseline and 12 months
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Hand-grip strength measured using a dynamometer.
Higher values indicate greater muscle strength.
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Baseline and 12 months
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Number of falls
時間枠：12 months
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Total number of falls recorded using a falls diary.
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12 months
|
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Change from baseline in cortisol levels
時間枠：Baseline and 12 months
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Cortisol concentration measured from hair samples (pg/mg).
Lower levels indicate better outcome.
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Baseline and 12 months
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Change from baseline in systolic blood pressure, mmHg.
時間枠：Baseline and 12 months
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Lower systolic blood pressure indicates a better outcome.
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Baseline and 12 months
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Change from baseline in diastolic blood pressure, mmHg.
時間枠：Baseline and 12 months
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Lower diastolic blood pressure indicates a better outcome.
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Baseline and 12 months
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Change from baseline in Body Mass Index (BMI), kg/m2.
時間枠：Baseline and 12 months
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Lower BMI value indicates a better outcome.
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Baseline and 12 months
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Change from baseline in waist circumference, cm.
時間枠：Baseline and 12 months
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Lower value indicates a better outcome.
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Baseline and 12 months
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Change from baseline in blood lipids - Total Cholesterol, mmol/L.
時間枠：Baseline and 12 months
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Measured from serum with lower cholesterol value indicating a better outcome.
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Baseline and 12 months
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Change from baseline in blood lipids - HDL Cholesterol, mmol/L.
時間枠：Baseline and 12 months
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Measured from serum with higher HDL cholesterol value indicating a better outcome.
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Baseline and 12 months
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Change from baseline in blood lipids - LDL Cholesterol, mmol/L.
時間枠：Baseline and 12 months
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Measured from serum with lower cholesterol value indicating a better outcome.
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Baseline and 12 months
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Change from baseline in blood triglycerides, mmol/L.
時間枠：Baseline and 12 months
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Measured from serum with lower triglycerides value indicating a better outcome.
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Baseline and 12 months
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Change from baseline in glycated haemoglobin (HbA1c), %
時間枠：Baseline and 12 months
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Measured from fasting blood sample, with lower HbA1c value indicating a better outcome.
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Baseline and 12 months
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Complete blood count (CBC)
時間枠：Baseline and 12 months
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Complete blood count measured from blood samples, including hemoglobin, leukocyte count, and platelet count.
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Baseline and 12 months
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Change from baseline in S-hsCRP (mg/l)
時間枠：Baseline and 12 months
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Measured from serum with lower values indicating a better outcome.
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Baseline and 12 months
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Change from baseline in physical functioning - Activities-specific Balance Confidence (ABC) Scale
時間枠：Baseline and 12 months
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Activities-specific Balance Confidence (ABC) Scale (0-100%).
Higher scores indicate greater confidence.
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Baseline and 12 months
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Change from baseline in physical functioning - Timed Up and Go (TUG)
時間枠：Baseline and 12 months
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Time required to complete the Timed Up and Go test.
Lower values indicate better mobility.
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Baseline and 12 months
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Change from baseline in physical functioning - Frailty (Fried's phenotype)
時間枠：Baseline and 12 months
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Frailty score based on five criteria (range 0-5).
Lower scores indicate less frailty.
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Baseline and 12 months
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Change from baseline in quality of life - Care-related Quality of Life instrument (CarerQol)
時間枠：Baseline, 12 months and 18 months
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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.
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Baseline, 12 months and 18 months
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Change from baseline in social well-being - Experiences of Social Inclusion Scale
時間枠：Baseline, 12 months and 18 months
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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.
|
Baseline, 12 months and 18 months
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Change from baseline in health-related quality of life - RAND-36 Health Survey
時間枠：Baseline and 12 months
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The scale values are ranging 0-100, with higher scores indicating a better outcome.
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Baseline and 12 months
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Change from baseline in stress-related symptoms
時間枠：Baseline and 12 months
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Perceived Stress Scale (PSS-10).
Values ranging 0-40, with lower scores indicating a better outcome.
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Baseline and 12 months
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Change from baseline in depressive symptoms
時間枠：Baseline and 12 months
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Center for Epidemiological Studies Depression scale.
Values ranging 0-60, with lower scores indicating a better outcome.
|
Baseline and 12 months
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Change from baseline in depressive symptoms
時間枠：Baseline and 12 months
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Geriatric Depression Scale (GDS).
Values ranging 0-15, with lower scores indicating a better outcome.
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Baseline and 12 months
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Change from baseline in nutrition - Mini-Nutritional Assessment (MNA)
時間枠：Baseline and 12 months
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Mini Nutritional Assessment (0-14).
Higher scores indicate better nutritional status.
|
Baseline and 12 months
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Change from baseline in nutrition - Global Leadership Initiative on Malnutrition (GLIM) criteria
時間枠：Baseline and 12 months
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Categorical classification (no malnutrition / moderate / severe).
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Baseline and 12 months
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Comorbidity (Functional Comorbidity Index score)
時間枠：Baseline and 12 months
|
List of diseases.
Measured as counts.
A lower number of diseases indicates a better outcome.
|
Baseline and 12 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 6/13.00/2026
- 362628 (その他の識別子：Research Council of Finland)
- 362706 (その他の識別子：Research Council of Finland)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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