STRONGER 60+: Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care

Not Applicable

Not yet recruiting

• Conditions: Older Adults at High Risk for MCI; Older Adults With Mild to Moderate Level of Dementia

• Registration Number: NCT07117916
• Lead Sponsor: Karolinska Institutet

Brief Summary

Background: The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. The aim of the STRONGER 60+ trial is to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care.

Methods and analysis: This 6-month randomized controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 96 participants will be randomized to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same program. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint), and 12 months post-randomization. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Study Start: 2026-08-01
• Primary Completion: 2028-02
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Individuals aged 60 and older who express interest in the study will be pre-screened by the research team using the CAIDE (Cardiovascular Risk Factors, Aging, and Dementia) Risk Score. Those scoring ≥6-indicating elevated dementia risk-will be invited for an in-person screening visit to confirm eligibility. The CAIDE score (range: 4-15) is based on age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity. Additional inclusion criteria are a Mini-Mental State Examination (MMSE) score of ≥24, and ability to walk independently indoors and outdoors (with or without a mobility aid).

Exclusion Criteria

Exclusion criteria include diagnosed dementia and residence in a nursing home.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite healthy lifestyle score	Assessments are conducted at baseline, 6 months (primary endpoint), and 12 months post-randomization	The primary outcome is a composite healthy lifestyle score encompassing four domains: dietary intake, physical activity, cognitive and social engagement (combined), and cardiovascular risk burden.