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BEAMERNCT06856902

BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe

StatusCompleted
PhaseNot applicable
Primary completion
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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 4 entries Show 7 more changesShow less
    • Eligibility criteria expanded, about 5 words
    • Trial completed
    • Final enrollment: 6190 participants (planned 3100)
    • Primary completion date changed from estimate of Jun 30, 2026 to Aug 30, 2026
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised at 10 of 10 sites
    • Collaborators: details revised at 2 of 13 entries
  2. Enrollment target: 7410 to 3100v3 Show 7 more changesShow less
    • Primary completion date: Dec 1, 2025 to Jun 30, 2026
    • Primary endpoints revised (4)
    • Study sites: 1 to 10
    • Study completion date: Dec 31, 2025 to Sep 30, 2026
    • Interventions: B-COMPASS implementation (Behavioral), B-COMPASS implementation (Behavioral) to B-COMPASS implementation (Behavioral)
    • Secondary endpoints: 3 to 4
    • Collaborators: 4 to 13
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 1, 2025 to Dec 1, 2025
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Accuracy of the B-COMPASS to predict adherence
Timeframe: At first data collection
Validity of B-COMPASS groupings
Timeframe: At second data collection which is 2 weeks - 6 months after first data collection (first and second data collection). It varies between pilot sites and disease area.
Accuracy of identification of patients' support needs
Timeframe: At second data collection which is 2 weeks - 6 months after first data collection (first and second data collection). It varies between pilot sites and disease area.
Reliability of B-COMPASS prediction over time
Timeframe: At first data collection and then aging at second data collection which is 2 weeks - 6 months after first data collection (first and second data collection). It varies between pilot sites and disease area.

Secondary (4)

Extent to which the B-COMPASS affects patient adherence to treatment
Patients' perceptions of the received engagement with HCPs based on B-COMPASS
Perception of HCPs of the B-COMPASS
Cost-effectiveness impact of B-COMPASS on healthcare utilisation

Arms and interventions

Control armNo intervention

At the first data collection, patients will complete the BEAMER questionnaire and adherence-related measures will be collected. Based on patients' answers, the B-COMPASS will assign them into groups, list their support needs, and predict their relative adherence, forming their B-COMPASS description. Patients will then be randomised into either 1) an intervention arm, or 2) a control arm using stratified randomisation via the Adherence Intelligence Visualisation Platform (AIVP), ensuring balance in B-COMPASS descriptions, gender, and age. Control patients will receive standard care and HCPs/Research Leads will not be informed of their B-COMPASS description. Where possible, at pilot sites, HCPs/Research Leads will also be randomised to ensure that HCPs/Research Leads in the control groups have as limited knowledge of the B-COMPASS/patient description as possible.

Intervention armActive comparator

At the first data collection, patients will complete the BEAMER questionnaire and adherence-related measures will be collected. Based on patients' answers, the B-COMPASS will assign them into groups, list their support needs, and predict their relative adherence, forming their B-COMPASS description. Patients will then be randomised into either 1) an intervention arm, or 2) a control arm using stratified randomisation via the Adherence Intelligence Visualisation Platform (AIVP), ensuring balance in B-COMPASS descriptions, gender, and age. The patients in the intervention arm will receive B-COMPASS enhanced engagement in addition to standard care. The enhanced engagement is implemented as educational material to the HCP who is engaging with the patient. The content of the educational material will be based on the patient's B-COMPASS patient description. The engagement will either be in person or via phone call depending on the patient visiting schedule of each recruited patient.

Behavioral: B-COMPASS implementation

Sites

10 sites in 8 countries

Portugal 2, Spain 2, Germany 1, Italy 1, Netherlands 1, Norway 1, Slovenia 1, Tanzania 1