STRONGER 60+ Trial Protocol: A Mixed-Methods Randomised Study of an Adapted FINGER Model in Prim

STRONGER 60+: framing a pragmatic test of a FINGER-based multidomain approach in primary care

The protocol emphasizes understanding how the intervention functions within routine clinical settings, including stakeholder perspectives and implementation processes.

The STRONGER 60+ trial tests an adaptation of that model specifically within Swedish primary care, with attention to external validity, feasibility, and transferability.

• The STRONGER 60+ trial is a pragmatic, mixed-methods randomized controlled study designed to evaluate both clinical effectiveness and real-world delivery of an adapted FINGER-based multidomain lifestyle intervention in primary care.
• The investigation follows the lineage of the FINGER model, which demonstrated potential cognitive and brain-health benefits from a multidomain program that couples nutrition, physical activity, cognitive training, social engagement, and cardiovascular/metabolic risk management.

The design is described as blinded outcome assessment to strengthen validity, framed within CONSORT guidance.

The protocol also aligns with SPIRIT reporting standards.

Recruitment is through clinic-based advertisements and public-facing channels.

Pre-screening uses a cardiovascular dementia risk screen, the CAIDE risk score, to identify individuals with elevated risk before in-person confirmation of eligibility.

This outcome focuses on the degree of adherence and behavioral modification across the multidomain components.

This includes evaluating recruitment, retention, and adherence metrics to illuminate implementation barriers and facilitators.

• Design: A six-month randomized controlled trial conducted in primary care clinics.
• Population and sampling frame: Adults aged 60 years and older who possess vascular or lifestyle-related risk factors for dementia are eligible.
• Interventions compared:
• Structured, supervised multidomain lifestyle program: In-person sessions that integrate nutritional guidance, physical exercise, cognitive training, social engagement activities, and management of vascular/metabolic risk factors.
• Self-guided version of the same program: The identical set of components delivered in an autonomous, self-directed format.
• Primary endpoint: Change in a composite healthy lifestyle score at six months.
• Follow-up: Assessments occur at baseline, at six months (the primary endpoint), and at twelve months post-randomization, enabling evaluation of medium-term persistence or attenuation of effects.
• Secondary aims: The protocol specifies exploration of delivery processes and stakeholder perspectives (participants and healthcare professionals) through a combination of qualitative and quantitative methods.

It notes that general dementia risk reduction requires multidomain strategies due to the multifactorial nature of disease risk.

Additional references point to subsequent WW-FINGERS network activity and parallel trials that have tested similar strategies, including populations with prodromal Alzheimer’s disease where feasibility and adherence appeared favorable.

STRONGER 60+ seeks to address this gap by evaluating both outcomes and implementation in routine care contexts.

• The background situates STRONGER 60+ within a public health frame that recognizes dementia as a substantial and growing global burden, with emphasis on prevention through modifiable risk factors.
• The FINGER trial’s core finding—that a two-year, multidomain program improved cognitive function and brain health—serves as the foundational evidence base for adapting this model to primary care.
• The protocol acknowledges a gap: while multidomain prevention has demonstrated promise in research settings, evidence on clinical effectiveness and practical delivery within primary care remains limited.

Data management and informed consent procedures conform to standard ethical norms.

The study design explicitly states the presence of a blinded outcome assessment component to reduce bias in measuring endpoints.

The study is designed to collect data at baseline, 6 months, and 12 months to illuminate trajectory and contextual factors.

The study adheres to the Declaration of Helsinki, with explicit attention to consent, confidentiality, and data management.

• Setting and governance: The trial is conducted in Swedish primary care facilities, adhering to ethical principles and regulatory approvals.
• Recruitment and eligibility verification:
• Initial contact through clinic and public postings.
• Pre-screening using the CAIDE risk score to identify individuals with elevated dementia risk (threshold meeting or exceeding a specified cutoff).
• In-person screening to confirm eligibility, including MMSE scoring of at least 24 and the ability to ambulate with or without aid.
• Exclusion criteria include a diagnosis of dementia and residence in a nursing home.
• Randomization and allocation: Eligible participants will be randomized to the structured program or the self-guided variant.
• Outcome measures and data collection:
• Primary outcome: Change in the composite healthy lifestyle score at six months, capturing the multidomain behavioral targets embedded in the intervention.
• Secondary and exploratory data: Although not detailed in the provided excerpt, the protocol indicates concurrent qualitative and quantitative evaluations of delivery processes, including stakeholder perspectives (participants and healthcare professionals).
• Ethical considerations: Multiple ethical approvals have been obtained from the Swedish Ethical Review Authority with unique reference numbers corresponding to different protocol components across study phases.

By incorporating a self-guided arm, the study also aims to parse the added value of structured, supervised delivery versus autonomous engagement, contributing to discussions about resource allocation and scalability in routine practice.

• The STRONGER 60+ protocol underscores the importance of translating evidence-based multidomain interventions from research settings into primary care, with deliberate attention to real-world feasibility, implementation challenges, and stakeholder acceptance.
• The inclusion of mixed methods to probe delivery processes aligns with contemporary efforts to understand implementation science aspects—such as recruitment efficiency, participant adherence, engagement with components (nutrition, exercise, cognitive training, social elements), and provider perspectives on feasibility and sustainability.

Consequently, while the primary endpoint is defined, the breadth of outcome domains remains unstated in this summary.

As a result, evaluation of statistical validity and the comprehensiveness of process evaluation cannot be fully assessed here.

The emphasis on local adaptation is acknowledged, but the scope of generalizability has not been defined in the provided text.

• The available protocol excerpt does not provide detailed information about specific measurement instruments for the healthy lifestyle composite, nor does it enumerate secondary outcomes such as changes in cognitive function, physical performance, quality of life, or cardiometabolic parameters.
• Details on sample size justification, power calculations, and the exact nature of qualitative and quantitative implementation measures are not provided in the excerpt.
• The applicability of findings to broader primary care settings outside Sweden, or to populations with different baseline risk profiles, remains an inferred consideration rather than explicitly stated in the protocol.
• While there is explicit commitment to open-access dissemination and stakeholder engagement, the practical implications of potential heterogeneity in delivery across clinics or regional variations are not detailed in the available content.

• If the structured, supervised delivery demonstrates superior maintenance of a healthy lifestyle profile at six months relative to the self-guided approach, findings would inform discussions about the relative value of in-person coaching within primary care-based prevention programs.
• The embedded implementation research component promises to yield practical insights into how such interventions might be integrated into routine care, what barriers clinicians and patients encounter, and what conditions support fidelity and reach.
• Open questions likely to be addressed in the full study include: the stability of behavioral changes beyond six months, how engagement correlates with adherence and outcomes, and the roles of social and motivational factors in sustaining lifestyle changes within primary care.

However, it does not report the full spectrum of secondary outcomes, the exact instruments used for the healthy lifestyle composite, nor the precise qualitative and quantitative analytic plans for implementation outcomes.

• The provided source clearly states the study’s age criteria, risk-factor-based inclusion strategy, primary endpoint definition, and the dual-arm design with a structured versus self-guided format.
• Commentary on generalizability beyond the Swedish primary care environment is not explicitly detailed in the protocol excerpt, though the authors frame the work within broader WHO recommendations for locally adapted dementia prevention in primary care.
• It is not reported in this excerpt whether the trial has interim analyses, attrition thresholds, or predefined criteria for trial modification or early stopping, which would be relevant for appraisal of methodological rigor in a pragmatic setting.

• STRONGER 60+ represents a pragmatic, primary-care–based test of an adapted FINGER-style multidomain intervention for adults aged 60 and up with elevated dementia risk, comparing a structured, supervised program to a self-guided version over six months, with follow-up at 12 months.
• The principal endpoint focuses on change in a composite healthy lifestyle score at six months, with secondary emphasis on implementation processes and stakeholder perspectives using mixed methods.