Frailty is a multidimensional syndrome in which a person accumulates age-related deficits across life domains, increasingly including social components such as social isolation. An estimated 12% of the Swiss population aged 65+ is frail and a further 46% pre-frail; without prevention, about two thirds of pre-frail persons will become frail, with major consequences for disability, hospitalisation, mortality, quality of life and health costs. Meta-analyses identify physical activity as the most promising prevention strategy, yet structured mechanisms connecting older adults with existing community activities remain underdeveloped and fragmented. To close this implementation gap, the ENGAGE implementation project co-designed a community participation support pathway with local stakeholders: older adults with low physical and/or social activity are systematically identified during routine contacts, a values-based conversation clarifies what matters to the person, the person is matched and referred to existing community activities, and a navigator (a social work professional acting as link worker) provides behavioural, practical and emotional support for initial and continued participation. Because there are uncertainties in the delivery of the study and intervention, a pilot study with a pragmatic randomised trial design is implemented.
Age ≥65 years
Community-dwelling in Basel-Stadt/Basel-Landschaf
Low levels of physical activity and/or low levels of social activity or perceptions of social isolation
Sufficient German to understand the study information
Residing in residential long-term care
Inability to move outside the home without another person's assistance (mobility aids and transport services are permitted)
Participation in a conflicting study
Severe cognitive impairment, severe psychiatric illness, communication barrier or sensory impairment precluding informed consent or meaningful engagement
Parallel
Navigation support
BehavioralThe navigator conducts a needs assessment and support an older person in finding and attending an appropriate community activities/services. They can offer a brief and limited set of behavioral change techniques (such as information about health consequences, goal setting, action planning, and discussing barriers) to support attendance and provide follow-up.
Coaching support
BehavioralCoaching will follow-up on the initial navigation support (e.g., needs elicitation, activity matching, goal setting, action planning), and will include a more intensive behavioural support. This will be based on motivational interviewing, which is used to conduct a live behavioural diangnosis using the COM-B model, and subsequent selection of one or more appropriate behavioural change techniques, individualised to the participant.
Progression decision to full trial
The primary endpoint for the pilot is the overall progression decision after the internal pilot, classified as: proceed to the full RCT without modifications; proceed with modifications; or stop.
Feasibility of start-up procedures
The endpoint will be expressed as the number and type of problems identified per procedure domain (recruitment, consent, home-visit procedures, baseline assessment, data entry, randomisation, communication with study partners, and preparation for intervention initiation). Problems will be categorised as minor operational issue, major operational issue requiring procedure change, or critical issues requiring amendments to the ethics dossier.
Number of potential participants screened, recruited, randomised and retained
The endpoint will be expressed as the number and proportion of potential participants identified, screened, eligible, consented, randomised, and retained until the month 3 follow-up.
Reasons for refusal, discontinuation, withdrawal or loss to follow-up
The endpoint will be expressed as the number and proportion of reasons for non-participation, discontinuation of the allocated pathway, withdrawal from study procedures, withdrawal of consent, and loss to follow-up where available.
Completeness of full-trial outcome data
The endpoint will be expressed as the number and proportion of participants with complete data per instrument and timepoint for the primary and key secondary full trial endpoints.
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Bastiaan Van Grootven
Lead sponsor
University of Basel
Sponsor institution
University of Basel
Collaborator
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