[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657345":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":58,"interventions":74,"overallOfficials":83,"centralContacts":50,"locations":88,"responsibleParty":106,"collaborators":109,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":50,"enrollmentInfo":122,"targetDuration":50,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":138,"whyStopped":50,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"University of Basel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"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.","From enrollment until month 3",[14,18,21,24,27,30,34,38,41,44,47],{"measure":15,"description":16,"timeFrame":17},"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.","From study enrolment until randomisation at around 2 weeks",{"measure":19,"description":20,"timeFrame":12},"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.",{"measure":22,"description":23,"timeFrame":12},"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.",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":28,"description":29,"timeFrame":12},"Parameters informing the full-trial sample-size assumptions:","The endpoint will be expressed as the observed standard deviation of the Tilburg Frailty Indicator at month 3, the observed residual standard deviation, the correlation between baseline and month 3 scores, and case-load per Navigator.",{"measure":31,"description":32,"timeFrame":33},"Contamination between study arms","The endpoint will be expressed as the number and proportion of participants per arm with documented contamination, categorised by type and source, with a short qualitative summary.","From enrollment until month 6",{"measure":35,"description":36,"timeFrame":37},"Adoption of the ENGAGE Pathway: number and percentage of approached organisations and individual deliverers reaching each adoption Stage.","The endpoint will be expressed, per implementation region, as: 1) the number and proportion of approached organisations and individual deliverers progressing through each stage of adoption; and 2) the number and type of operational deliverers and case-finding routes. The endpoint will be measured using the ENGAGE Implementation Logbook.","From enrolment until month 3",{"measure":39,"description":40,"timeFrame":37},"Implementation-Strategy Fidelity: number and percentage of prespecified implementation strategies delivered as planned, partially delivered, or not delivered.","Implementation-strategy fidelity is defined as the degree to which the research team delivered the prespecified implementation strategies as specified, against each strategy's prespecified actor, action, dose and temporality. The endpoint will be expressed as: 1) the number and proportion of prespecified implementation strategies classified as delivered as planned, partially delivered, or not delivered; and 2) the reasons for partial or non-delivery. The endpoint will be measured using the ENGAGE Implementation Logbook.",{"measure":42,"description":43,"timeFrame":12},"Implementer experience and perceptions:","The endpoint will be expressed as a thematic summary and recommended adaptations for the full trial.",{"measure":45,"description":46,"timeFrame":12},"Delivered dose and participant responsiveness: number and percentage of participants achieving each engagement milestone, and number and duration of navigator and coaching contacts received.","Delivered dose is the number, mode, content and duration of navigator and coaching contacts provided to participants. Participant responsiveness is the degree to which participants engage with the support and the activities, covering enrolment in, first attendance at, and continued participation in community activities; discontinuation; and engagement with navigator and coaching contacts. The endpoint will be expressed, separately by study arm, as: 1) the number and proportion of participants achieving each engagement milestone; and 2) the number and duration (minutes) of navigator and coaching contacts received per participant. The endpoint will be measured using the ENGAGE Intervention Logbook.",{"measure":48,"description":49,"timeFrame":12},"Participant experience, perceived value and determinants of participation","The endpoint will be expressed as a thematic summary of participant experience.",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":54,"primaryPurpose":55,"observationalModel":50,"timePerspective":50,"maskingInfo":56},"RANDOMIZED","PARALLEL","Internal pilot study design, using predefined progression criteria to determine progression to full trial.","HEALTH_SERVICES_RESEARCH",{"masking":57,"maskingDescription":50,"whoMasked":50},"NONE",[59,63,69],{"label":60,"type":61,"description":62,"interventionNames":50},"Standard of care","NO_INTERVENTION","Participants remain free to receive usual care, professional advice, community information and community services that would normally be available outside the study.",{"label":64,"type":65,"description":66,"interventionNames":67},"Navigation support","EXPERIMENTAL","In intervention arm 1, patients are connected with a navigator. The navigator is a social worker trained to conduct a needs assessment and support an older person in finding and attending an appropriate community activities\u002Fservices.",[68],"Behavioral: Navigation support",{"label":70,"type":65,"description":71,"interventionNames":72},"Navigation and support support","In intervention arm 2, patients are connected with a navigator and a coach. Navigator support in this arm will be the same as for intervention arm 1, while the coaching will be provided by a trained member of the trial team. Coaching will follow-up on the initial navigation support, and will include a more intensive behavioural support.",[68,73],"Behavioral: Coaching support",[75,79],{"type":76,"name":64,"description":77,"armGroupLabels":78,"otherNames":50},"BEHAVIORAL","The navigator conducts a needs assessment and support an older person in finding and attending an appropriate community activities\u002Fservices. 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.",[70,64],{"type":76,"name":80,"description":81,"armGroupLabels":82,"otherNames":50},"Coaching support","Coaching 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.",[70],[84],{"name":85,"affiliation":86,"role":87},"Bastiaan Van Grootven","University of Basel - Public Health - Nursing Science","PRINCIPAL_INVESTIGATOR",[89],{"facility":90,"status":50,"city":91,"state":50,"zip":50,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Institute of Nursing Science","Basel","Switzerland","CH",{"type":95,"coordinates":96},"Point",[97,98],7.57327,47.55839,{"lat":98,"lon":97},[101],{"name":102,"role":103,"phone":104,"phoneExt":50,"email":105},"Aurora Monticelli","CONTACT","+41612076464","engage-nursing@unibas.ch",{"type":107,"investigatorFullName":85,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"SPONSOR_INVESTIGATOR","SNF Ambizione Fellow",[110],{"name":5,"class":6},"100657345","a-pilot-study-to-explore-the-feasibility-of-navigator-and-coach-support-for-community-participation-by-older-people-100657345",false,"NCT07836465","A Pilot Study to Explore the Feasibility of Navigator and Coach Support for Community Participation by Older People","A Randomised Pilot Study of Navigator and Coach Support for Participation in Community Activities to Promote Physical Activity and Social Contact in Persons Aged 65 Years and Older","ENGAGE","Inclusion Criteria:\n\n* Age ≥65 years\n* Community-dwelling in Basel-Stadt\u002FBasel-Landschaf\n* Low levels of physical activity and\u002For low levels of social activity or perceptions of social isolation\n* Sufficient German to understand the study information\n* Give written informed consent\n\nExclusion Criteria:\n\n* Residing in residential long-term care\n* Inability to move outside the home without another person's assistance (mobility aids and transport services are permitted)\n* Participation in a conflicting study\n* Severe cognitive impairment, severe psychiatric illness, communication barrier or sensory impairment precluding informed consent or meaningful engagement",true,"ALL","65 Years",{"count":123,"type":124},45,"ESTIMATED","INTERVENTIONAL",[127],"NA","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\u002For 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.",[130,131,132],"Frailty","Social Isolation in Older Adults","Frailty in Older Adults",[134,135,136,137],"Pilot study","Pragmatic trial","Social prescribing","Behavioural change","NOT_YET_RECRUITING","2026-09-19",{"date":141,"type":142},"2026-09-23","ACTUAL",{"date":144,"type":124},"2026-10-01",{"date":146,"type":124},"2028-09-30",{"name":85,"class":6},1]