STRONGER 60+: study protocol for a mixed-methods randomised controlled trial assessing the clinical effectiveness and delivery of an adapted FINGER model for brain health in primary care

Abstract

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. This paper presents the protocol for the STRONGER 60+trial, which aims 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 randomised 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 80 participants will be randomised to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same programme. 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-randomisation. 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. ETHICS AND DISSEMINATION: The study has been approved by the Swedish Ethical Review Authority (approval numbers: 2020-05785, 2021-06413-02, 2022-05454-02) and will follow the principles of the Declaration of Helsinki. Ethical procedures for informed consent, confidentiality and data management will be strictly observed. Results will be disseminated through scientific publications, conferences and targeted outreach to healthcare professionals and the general public. TRIAL REGISTRATION NUMBER: NCT07117916.