Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Family FINGER: Lifestyle Intervention Among Older Caregivers

6 juillet 2026 mis à jour par: Tarja Välimäki

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?

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Finlande
      • Kuopio, Finlande, 70210
        • Recrutement
        • Department of Nursing Science
        • Contact:
        • Chercheur principal:
          • Tarja Välimäki, PhD
        • Chercheur principal:
          • Tiia Ngandu, MD, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Soins standards
Expérimental: Healthy Lifestyle Intervention
Comportemental: a 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.
Autres noms:
  • Family FINGER

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Délai: 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.
Baseline, 6 months, 12 months, and 18 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in healthy lifestyle
Délai: 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.
Baseline, 12 months and 18 months
Change from baseline in dementia risk (LIBRA score)
Délai: 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.
Baseline and 12 months
Change from baseline in dementia risk (CAIDE score)
Délai: Baseline and 12 months
Cardiovascular Risk Factors, Aging and Dementia (CAIDE) score (range 0-15 points). Lower scores indicate lower dementia risk.
Baseline and 12 months
Change from baseline in cognitive function (MoCA score)
Délai: Baseline and 12 months
Montreal Cognitive Assessment (MoCA) total score (range 0-30). Higher scores indicate better cognitive function.
Baseline and 12 months
Change from baseline in dietary intake
Délai: Baseline and 12 months
Dietary quality assessed using the adapted FINGER Diet Index (range 0-9). Higher scores indicate better adherence to dietary recommendations.
Baseline and 12 months
Change from baseline in physical activity frequency (sessions/week)
Délai: Baseline and 12 months
Number of moderate-to-vigorous physical activity sessions per week. Higher values indicate greater physical activity.
Baseline and 12 months
Change from baseline in physical activity
Délai: 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.
Baseline and 12 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Feasibility (retention rate)
Délai: 12 months
Proportion of randomized participants completing the 12-month assessment. Higher percentages indicate better retention.
12 months
Feasibility (qualitative evaluation)
Délai: Baseline and 12 months
Qualitative interviews assessing feasibility and acceptability of the intervention.
Baseline and 12 months
Change from baseline in objectively measured physical activity (Actigraph)
Délai: Baseline and 12 months
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.
Baseline and 12 months
Change from baseline in instrumental activities of daily living (IADL score)
Délai: Baseline, 12 months and 18 months
Instrumental Activities of Daily Living (IADL) score (range 0-8). Higher scores indicate greater independence.
Baseline, 12 months and 18 months
Change from baseline in activities of daily living (Barthel Index score)
Délai: Baseline, 12 months and 18 months
Barthel Index score (range 0-100). Higher scores indicate greater independence in daily activities.
Baseline, 12 months and 18 months
Change from baseline in physical performance (SPPB score)
Délai: Baseline and 12 months
Short Physical Performance Battery (SPPB) total score (range 0-12). Higher scores indicate better lower extremity function.
Baseline and 12 months
Change from baseline in hand-grip strength (kg)
Délai: Baseline and 12 months
Hand-grip strength measured using a dynamometer. Higher values indicate greater muscle strength.
Baseline and 12 months
Number of falls
Délai: 12 months
Total number of falls recorded using a falls diary.
12 months
Change from baseline in cortisol levels
Délai: Baseline and 12 months
Cortisol concentration measured from hair samples (pg/mg). Lower levels indicate better outcome.
Baseline and 12 months
Change from baseline in systolic blood pressure, mmHg.
Délai: Baseline and 12 months
Lower systolic blood pressure indicates a better outcome.
Baseline and 12 months
Change from baseline in diastolic blood pressure, mmHg.
Délai: Baseline and 12 months
Lower diastolic blood pressure indicates a better outcome.
Baseline and 12 months
Change from baseline in Body Mass Index (BMI), kg/m2.
Délai: Baseline and 12 months
Lower BMI value indicates a better outcome.
Baseline and 12 months
Change from baseline in waist circumference, cm.
Délai: Baseline and 12 months
Lower value indicates a better outcome.
Baseline and 12 months
Change from baseline in blood lipids - Total Cholesterol, mmol/L.
Délai: Baseline and 12 months
Measured from serum with lower cholesterol value indicating a better outcome.
Baseline and 12 months
Change from baseline in blood lipids - HDL Cholesterol, mmol/L.
Délai: Baseline and 12 months
Measured from serum with higher HDL cholesterol value indicating a better outcome.
Baseline and 12 months
Change from baseline in blood lipids - LDL Cholesterol, mmol/L.
Délai: Baseline and 12 months
Measured from serum with lower cholesterol value indicating a better outcome.
Baseline and 12 months
Change from baseline in blood triglycerides, mmol/L.
Délai: Baseline and 12 months
Measured from serum with lower triglycerides value indicating a better outcome.
Baseline and 12 months
Change from baseline in glycated haemoglobin (HbA1c), %
Délai: Baseline and 12 months
Measured from fasting blood sample, with lower HbA1c value indicating a better outcome.
Baseline and 12 months
Complete blood count (CBC)
Délai: Baseline and 12 months
Complete blood count measured from blood samples, including hemoglobin, leukocyte count, and platelet count.
Baseline and 12 months
Change from baseline in S-hsCRP (mg/l)
Délai: Baseline and 12 months
Measured from serum with lower values indicating a better outcome.
Baseline and 12 months
Change from baseline in physical functioning - Activities-specific Balance Confidence (ABC) Scale
Délai: Baseline and 12 months
Activities-specific Balance Confidence (ABC) Scale (0-100%). Higher scores indicate greater confidence.
Baseline and 12 months
Change from baseline in physical functioning - Timed Up and Go (TUG)
Délai: Baseline and 12 months
Time required to complete the Timed Up and Go test. Lower values indicate better mobility.
Baseline and 12 months
Change from baseline in physical functioning - Frailty (Fried's phenotype)
Délai: Baseline and 12 months
Frailty score based on five criteria (range 0-5). Lower scores indicate less frailty.
Baseline and 12 months
Change from baseline in quality of life - Care-related Quality of Life instrument (CarerQol)
Délai: Baseline, 12 months and 18 months
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.
Baseline, 12 months and 18 months
Change from baseline in social well-being - Experiences of Social Inclusion Scale
Délai: Baseline, 12 months and 18 months
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
Change from baseline in health-related quality of life - RAND-36 Health Survey
Délai: Baseline and 12 months
The scale values are ranging 0-100, with higher scores indicating a better outcome.
Baseline and 12 months
Change from baseline in stress-related symptoms
Délai: Baseline and 12 months
Perceived Stress Scale (PSS-10). Values ranging 0-40, with lower scores indicating a better outcome.
Baseline and 12 months
Change from baseline in depressive symptoms
Délai: Baseline and 12 months
Center for Epidemiological Studies Depression scale. Values ranging 0-60, with lower scores indicating a better outcome.
Baseline and 12 months
Change from baseline in depressive symptoms
Délai: Baseline and 12 months
Geriatric Depression Scale (GDS). Values ranging 0-15, with lower scores indicating a better outcome.
Baseline and 12 months
Change from baseline in nutrition - Mini-Nutritional Assessment (MNA)
Délai: Baseline and 12 months
Mini Nutritional Assessment (0-14). Higher scores indicate better nutritional status.
Baseline and 12 months
Change from baseline in nutrition - Global Leadership Initiative on Malnutrition (GLIM) criteria
Délai: Baseline and 12 months
Categorical classification (no malnutrition / moderate / severe).
Baseline and 12 months
Comorbidity (Functional Comorbidity Index score)
Délai: Baseline and 12 months
List of diseases. Measured as counts. A lower number of diseases indicates a better outcome.
Baseline and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tarja Välimäki

Collaborateurs

Karolinska Institutet
University of California, Davis
Tampere University
Finnish Institute for Health and Welfare
Carers Finland
Alzheimer Society of Finland

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

22 juin 2026

Achèvement primaire (Estimé)

30 avril 2028

Achèvement de l'étude (Estimé)

30 avril 2028

Dates d'inscription aux études

Première soumission

15 mai 2026

Première soumission répondant aux critères de contrôle qualité

29 mai 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 6/13.00/2026
  • 362628 (Autre identifiant: Research Council of Finland)
  • 362706 (Autre identifiant: Research Council of Finland)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

The Family FINGER Trial Steering Group is open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. The Family FINGER Trial Steering Group will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing Family FINGER analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the Family FINGER Trial Steering Group. Access is subject to the applicable legal framework. An access agreement will be prepared and signed by both parties.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner