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Family FINGER: Lifestyle Intervention Among Older Caregivers

29 maggio 2026 aggiornato da: 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?

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Finlandia
      • Kuopio, Finlandia, 70210
        • Department of Nursing Science
        • Contatto:
        • Investigatore principale:
          • Tarja Välimäki, PhD
        • Investigatore principale:
          • Tiia Ngandu, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Cura standard
Sperimentale: Healthy Lifestyle Intervention
Comportamentale: 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.
Altri nomi:
  • Family FINGER

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in positive mental health - Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in healthy lifestyle
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility (retention rate)
Lasso di tempo: 12 months
Proportion of randomized participants completing the 12-month assessment. Higher percentages indicate better retention.
12 months
Feasibility (qualitative evaluation)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Baseline and 12 months
Hand-grip strength measured using a dynamometer. Higher values indicate greater muscle strength.
Baseline and 12 months
Number of falls
Lasso di tempo: 12 months
Total number of falls recorded using a falls diary.
12 months
Change from baseline in cortisol levels
Lasso di tempo: 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.
Lasso di tempo: Baseline and 12 months
Lower systolic blood pressure indicates a better outcome.
Baseline and 12 months
Change from baseline in diastolic blood pressure, mmHg.
Lasso di tempo: 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.
Lasso di tempo: Baseline and 12 months
Lower BMI value indicates a better outcome.
Baseline and 12 months
Change from baseline in waist circumference, cm.
Lasso di tempo: Baseline and 12 months
Lower value indicates a better outcome.
Baseline and 12 months
Change from baseline in blood lipids - Total Cholesterol, mmol/L.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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), %
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline and 12 months
Categorical classification (no malnutrition / moderate / severe).
Baseline and 12 months
Comorbidity (Functional Comorbidity Index score)
Lasso di tempo: Baseline and 12 months
List of diseases. Measured as counts. A lower number of diseases indicates a better outcome.
Baseline and 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tarja Välimäki

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

28 maggio 2026

Completamento primario (Stimato)

30 aprile 2028

Completamento dello studio (Stimato)

30 aprile 2028

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 6/13.00/2026
  • 362628 (Altro identificatore: Research Council of Finland)
  • 362706 (Altro identificatore: Research Council of Finland)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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