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NCT Number: NCT07836465

A Pilot Study to Explore the Feasibility of Navigator and Coach Support for Community Participation by Older People

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.

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Key information

Conditions

Frailty Frailty in Older Adults Pathologic Processes Pathological Conditions, Signs and Symptoms Social Isolation in Older Adults

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Give written informed consent

Exclusion criteria

  • 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

Treatment and study plan

Navigation support

Behavioral

The 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

Behavioral

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.

Primary outcomes

  1. Progression decision to full trial

    Time frame: From enrollment until month 3

    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.

Secondary outcomes

  1. Feasibility of start-up procedures

    Time frame: From study enrolment until randomisation at around 2 weeks

    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.

  2. Number of potential participants screened, recruited, randomised and retained

    Time frame: From enrollment until month 3

    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.

  3. Reasons for refusal, discontinuation, withdrawal or loss to follow-up

    Time frame: From enrollment until month 3

    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.

  4. Completeness of full-trial outcome data

    Time frame: From enrollment until month 3

    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.

  5. Parameters informing the full-trial sample-size assumptions:

    Time frame: From enrollment until month 3

    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.

  6. Contamination between study arms

    Time frame: From enrollment until month 6

    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.

  7. Adoption of the ENGAGE Pathway: number and percentage of approached organisations and individual deliverers reaching each adoption Stage.

    Time frame: From enrolment until month 3

    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.

  8. Implementation-Strategy Fidelity: number and percentage of prespecified implementation strategies delivered as planned, partially delivered, or not delivered.

    Time frame: From enrolment until month 3

    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.

  9. Implementer experience and perceptions:

    Time frame: From enrollment until month 3

    The endpoint will be expressed as a thematic summary and recommended adaptations for the full trial.

  10. Delivered dose and participant responsiveness: number and percentage of participants achieving each engagement milestone, and number and duration of navigator and coaching contacts received.

    Time frame: From enrollment until month 3

    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.

  11. Participant experience, perceived value and determinants of participation

    Time frame: From enrollment until month 3

    The endpoint will be expressed as a thematic summary of participant experience.

Sponsors and collaborators

Lead sponsor

Bastiaan Van Grootven

Other

Collaborators

  • University of Basel

Registry information

Official study title

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

Acronym: ENGAGE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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