Actively Recruiting
BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe
Led by Technical University of Madrid · Updated on 2026-04-01
3100
Participants Needed
10
Research Sites
13 weeks
Total Duration
On this page
Sponsors
T
Technical University of Madrid
Lead Sponsor
U
University of Oslo
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to validate the B-COMPASS, a computational model developed by the BEAMER project to improve patient adherence to treatment across various diseases. Adherence to treatment is a widespread issue leading to increased healthcare use and premature death, with about half of medications not taken as prescribed. The study evaluates the model's ability to predict adherence, identify patient support needs, and enhance healthcare engagement in six therapeutic areas, including cardiovascular, endocrinology, immunology, neurology, oncology, and rare diseases. Participants complete the BEAMER questionnaire, which the B-COMPASS uses to group patients based on their adherence needs and predict their adherence. Patients are randomized into a control group receiving standard care or an intervention group receiving enhanced engagement through educational materials for healthcare providers tailored to the patient's B-COMPASS profile. Engagement occurs in person or by phone, depending on patient schedules, and healthcare providers may also be randomized to limit knowledge of the B-COMPASS in control groups. Participants are involved in two main data collections spaced from 2 weeks to 6 months apart, during which adherence measures, patient support needs, and perceptions of engagement are assessed. The study measures the accuracy, validity, and reliability of B-COMPASS predictions, its impact on adherence, patient and provider perceptions, and cost-effectiveness. The total participation timeline varies by site and disease area, with continuous monitoring of healthcare utilization and patient experience.
CONDITIONS
Brief Title
BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis in one of the pilot site's target groups (cardiovascular, endocrinology, immunology, neurology, oncology, or rare diseases)
- Be within the age range specified by the pilot site
- Have agreed to participate and provided written informed consent
- Be available to participate in all study activities
You will not qualify if you...
- Individuals who do not meet all the inclusion criteria will not be allowed to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks to 6 months depending on pilot site and disease area
Participants complete the BEAMER questionnaire and adherence-related measures. They are then randomized to receive either standard care or B-COMPASS enhanced engagement, which involves educational material for healthcare providers tailored to the participant's B-COMPASS profile. Engagement may occur in person or via phone based on participant schedules.
At least 2 visits: initial data collection and follow-up data collection
Trial Site Locations
Total: 10 locations
1
UDUS - Heinrich-Heine-University Duesseldorf
Düsseldorf, Germany
Actively Recruiting
2
FISM - Italian Multiple Sclerosis Foundation
Genova, Italy
Actively Recruiting
3
WDO - World Duchenne Organization
Veenendaal, Netherlands
Actively Recruiting
4
AHUS - Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Actively Recruiting
5
APDP Diabetes Portugal
Lisbon, Portugal, 1250-203
Actively Recruiting
6
MEDCIDS - Departamento de Medicina da Comunidade Informação e Decisão em Saúde
Porto, Portugal
Actively Recruiting
7
UMCM - University Medical Center Maribor
Maribor, Slovenia
Actively Recruiting
8
FHUNJ - Fundación para la Investigación Biomédica del Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Actively Recruiting
9
FIIBAP - Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria
Madrid, Spain
Actively Recruiting
10
KCRI - Kilimanjaro Clinical Research Institute
Moshi, Tanzania
Not Yet Recruiting
Research Team
G
Giuseppe Fico, Professor
B
Beatriz Merino, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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