FrailtyENGAGENCT07836465
A Pilot Study to Explore the Feasibility of Navigator and Coach Support for Community Participation by Older People
A study testing Navigation support and Coaching support in people with Frailty and Social Isolation in Older Adults, run by Bastiaan Van Grootven at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Social Isolation in Older Adults, Frailty in Older Adults
- What is being tested?
- Navigation support and Coaching support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Institute of Nursing Science
Basel
Aurora Monticelli, +41612076464, engage-nursing@unibas.ch
About this study
Official 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
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.
- Being tested
- Navigation support, Coaching support
- Keywords
- Pilot study, Pragmatic trial, Social prescribing, Behavioural change
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation supportBehavioural
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 supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
| 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/services. Receives: Behavioral: Navigation support |
| Navigation and support support | Experimental | 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. Receives: Behavioral: Navigation support; Behavioral: Coaching support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until month 3
Secondary outcomes (11)
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.
Measured: From study enrolment until randomisation at around 2 weeks
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.
Measured: From enrollment until month 3
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.
Measured: From enrollment until month 3
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.
Measured: From enrollment until month 3
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.
Measured: From enrollment until month 3
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.
Measured: From enrollment until month 6
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.
Measured: From enrolment until month 3
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.
Measured: From enrolment until month 3
Implementer experience and perceptions:
The endpoint will be expressed as a thematic summary and recommended adaptations for the full trial.
Measured: From enrollment until month 3
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.
Measured: From enrollment until month 3
Participant experience, perceived value and determinants of participation
The endpoint will be expressed as a thematic summary of participant experience.
Measured: From enrollment until month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Internal pilot study design, using predefined progression criteria to determine progression to full trial.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Van Grootven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor-investigator, Bastiaan Van Grootven, University of Basel
- Investigators
- Bastiaan Van Grootven, Principal investigator, University of Basel - Public Health - Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836465
- Sponsor's protocol ID
- 2026-01725
- Other IDs
- 223834
- Acronym
- ENGAGE
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The endpoints in this pilot study concern feasibility indicators. The results in itself provide the full data. If a progression to the full trial is made, a separate registration with IPD will be made.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07836465
- Acronym / sponsor ID
- ENGAGE / 2026-01725
- Keywords
- Pilot study, Pragmatic trial, Social prescribing, Behavioural change
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Bastiaan Van GrootvenUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Internal pilot study design, using predefined progression criteria to determine progression to full trial.
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Navigation support | Experimental | Behavioral: Navigation supportIn 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/services. |
| Navigation and support support | Experimental | Behavioral: Navigation support, Behavioral: Coaching supportIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigation supportThe 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. | Behavioural | Navigation and support support, Navigation support |
| Coaching supportCoaching 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. | Behavioural | Navigation and support support |
Primary outcome
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.
11 secondary outcomes
Feasibility of start-up procedures
Time frame: From study enrolment until randomisation at around 2 weeks
Number of potential participants screened, recruited, randomised and retained
Time frame: From enrollment until month 3
Reasons for refusal, discontinuation, withdrawal or loss to follow-up
Time frame: From enrollment until month 3
Completeness of full-trial outcome data
Time frame: From enrollment until month 3
Parameters informing the full-trial sample-size assumptions:
Time frame: From enrollment until month 3
Contamination between study arms
Time frame: From enrollment until month 6
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
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
Implementer experience and perceptions:
Time frame: From enrollment until month 3
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
Participant experience, perceived value and determinants of participation
Time frame: From enrollment until month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Project website at instituteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The endpoints in this pilot study concern feasibility indicators. The results in itself provide the full data. If a progression to the full trial is made, a separate registration with IPD will be made.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bastiaan Van Grootven principal investigator
University of Basel - Public Health - Nursing Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation support and Coaching support in people with Frailty and Social Isolation in Older Adults, run by Bastiaan Van Grootven at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression decision to full trial (time frame: From enrollment until month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.