Cardiovascular DiseasesBEAMERNCT06856902
BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe
A study testing B-COMPASS implementation in people with Cardiovascular Diseases and Endocrinology, run by Technical University of Madrid at 10 sites in 8 countries.
Trial summary
Lack of adherence to treatment is a widespread issue worldwide, which leads to higher healthcare utilisation rates and even premature death. While the level of adherence may differ based on the specific condition and treatment, studies estimate that approximately 50% of medications are not taken according to the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Endocrinology, Inmunology
- What is being tested?
- B-COMPASS implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,190 participants
- Where
- 10 sitesin 8 countries
- Study dates
- 1 Mar 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having the diagnosis of the pilot sites target groups described above as per clinical assessment or validated diagnosis criteria
- Having the age of the pilot sites target groups described above
- Having accepted to participate in the study and provided written informed consent
- Having the availability to participate on all study activities
Who cannot join
- Individuals that do not fulfil ALL the inclusion criteria will be excluded to participate.
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Portugal2 sites
APDP Diabetes Portugal
Lisbon, 1250-203
MEDCIDS - Departamento de Medicina da Comunidade Informação e Decisão em Saúde
Porto
Spain2 sites
FHUNJ - Fundación para la Investigación Biomédica del Hospital Infantil Universitario Niño Jesús
Madrid
FIIBAP - Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria
Madrid
About this study
Lack of adherence to treatment is a widespread issue worldwide, which leads to higher healthcare utilisation rates and even premature death. While the level of adherence may differ based on the specific condition and treatment, studies estimate that approximately 50% of medications are not taken according to the prescribed instructions. In addition, adherence rates tend to decrease even further when the treatment requires a behavioural change. Literature reviews about factors that affect people's adherence show that it is challenging to predict whom can be considered to have adherent and non-adherent behaviours. In addition, the studies highlight that it is challenging to support a person to be adherent. Based on this knowledge the BEAMER project was established (Behavioural and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe). The overall goal of the project is to improve the quality of life of individuals, enhance healthcare accessibility and sustainability, thereby transforming the way healthcare stakeholders engage with patients to understand their condition and adherence levels throughout their healthcare journey. To address the overall goal, the BEAMER project has developed a disease agnostic model named "B-COMPASS: BEAMER-COmputational Model for Patient Adherence and Support Solutions". The aim of the B-COMPASS is to identify patients' needs and preferences which enables the creation of patient-specific supports, with the intention of improving their adherence to treatment within the heterogeneity of the different disease-areas and healthcare contexts. Based on the validated BEAMER questionnaire, the B-COMPASS predicts relative adherence and offers an elicitation process of patient needs and preferences to enable targeted supports to improve patient adherence. This results in an allocation of patients to different groups based on their needs and preferences. Overall, the B-COMPASS provides patient insights that will enable more effective design of patient support, most likely resulting in better patient experience, improved adherence and lower healthcare and societal costs.
So far, several activities from a technical and user perspective have already been conducted in the project to refine the B-COMPASS. This has been done by applying an iterative mixed method approach were both stakeholders (regulator, pharma, academic/research and small and medium-sized enterprises) and end users (patients, health providers and health systems) have been involved. Despite the finetuning of the B-COMPASS, the effectiveness of the B-COMPASS hinges on empirical investigations into the structural elements that impact patient behaviour and the identification of predictive factors that can assist healthcare providers' (HCP) and Research Leads in designing more effective treatment plans (the term HCPs/Research Lead include both the individuals and the institutions where care is delivered). Therefore, validation studies will be conducted to assess the B-COMPASS's performance in six therapeutic areas (cardiovascular, endocrinology, immunology, neurology, oncology and rare diseases) with patients recruited in at least Italy (FISM), Portugal (APDP and MEDIDA) Norway (AHUS), Spain (FHUNJ and FIIBAP), The Netherlands (WDO), and Germany (UDUS). The collected data will be used to evaluate the B-COMPASS's capacity to attend to a variety of needs and challenges for adherence.
Read the detailed description
The aim of the study is to validate the B-COMPASS in real-life settings. Overall, the purpose is to provide evidence 1) to validate the B-COMPASS (primary purpose), and 2) to demonstrate the effectiveness and implementability of the B-COMPASS (secondary purpose). The project will carry out the final iterative steps of refining the model, guided by the validation studies that have been conducted. This process will be based on evaluating the performance of the generic model across six selected therapeutic areas (cardiovascular, endocrinology, immunology, neurology, oncology and rare diseases). Study participants (patients and HCPs) will be recruited (at least) from Italy, Portugal, Norway, Spain, The Netherlands, and Germany, and the validation will evaluate the capacity to attend to a variety of needs and challenges for adherence to treatment.
Overall, the study has 8 Scientific Questions (SQs), where SQ 1-4 address the validity of the B-COMPASS (primary purpose) and SQ 5-8 address the effectiveness and implementability of the B-COMPASS (secondary purpose). The SQs are:
SQ 1 How accurately does the B-COMPASS predict the relative adherence to treatment for patients? SQ 2 How valid are the B-COMPASS groupings? SQ 3 How accurately are the patient support needs identified by the B-COMPASS? SQ 4 How reliable is the B-COMPASS over time? SQ 5 To what extent does the use of the B-COMPASS affect patient adherence to treatment? SQ 6 How do the patients perceive the received engagement with HCPs/Research Leads based on the B-COMPASS? SQ 7 How do HCPs/Research Leads perceive the B-COMPASS? SQ 8 How does the B-COMPASS impact the cost-effectiveness of healthcare utilisation?
- Conditions
- Cardiovascular Diseases, Endocrinology, Inmunology, Neurology, Oncology, Rare Diseases
- Being tested
- B-COMPASS implementation
- Keywords
- Digital health, adherence to treatment, healthcare
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Rare Diseases, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-COMPASS implementationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No 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 arm | Active 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. Receives: Behavioral: B-COMPASS implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the B-COMPASS to predict adherence
Predictive accuracy of B-COMPASS of adherence to treatment will be validated against TAP-Q in Visit 1 and other specific adherence measurements for all participants.
The B-COMPASS is an adherence prediction model based on the BEAMER questionnaire, which is a questionnaire that contains 22 questions about subjective health experience and subjective awareness of health condition. Likert scale with 7 response options, 1 = Fully disagree, 7 = Fully agree (11 questions). Likert scale with 6 response options, 1 = Fully disagree, 6 = Fully agree (4 questions). Likert scale with 5 response options, 1 = Fully disagree, 5 = Fully agree (5 questions). Score on a 10-step ladder where step 1 = The day at the past 4 weeks I felt at my worst, step 10 = The day in the past 4 weeks I felt at my best (2 questions).
Measured: At first data collection
Validity of B-COMPASS groupings
B-COMPASS groupings will be validated through the qualitative thematic analysis of interviews and focus groups with patients and HCPs in the intervention groups.
Measured: 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
The accuracy of the support needs identified by the B-COMPASS will also be analysed through qualitative analysis of focus groups and interviews with the intervention groups.
Measured: 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
The over-time reliability of the B-COMPASS will be measured by comparing its groupings and adherence prediction results at the first and second visits for the control group.
Measured: 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 outcomes (4)
Extent to which the B-COMPASS affects patient adherence to treatment
The impact of the engagement prompted by the support needs identified by the B-COMPASS model on the adherence, will be measured through pre-post intervention design using adherence measurements results from the first and second visits (changes from baseline).
Adherence will be measured through TAP-Q, MARS-5, or dispensation and prescription electronic records, as specified above.
Measured: 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.
Patients' perceptions of the received engagement with HCPs based on B-COMPASS
Patients' experience and perceptions will be measured by a perspectives of B-COMPASS Likert-scale questionnaire that have 5 questions, as well as semi-structured interviews in the intervention group.
The study patient perceptions questionnaire contains 5 questions (i) understanding of how to adhere to treatment, (ii) perceptions regarding whether the received support is useful (iii) perceptions regarding whether the tools received is sufficient to adhere to treatment, (iv) perception regarding whether the given support motivates the patient to be adherent, and (v) satisfaction with the support received.
Likert scale with 7 response options, 1 = Fully disagree, 7 = Fully agree.
Measured: 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.
Perception of HCPs of the B-COMPASS
HCPs perceptions will be measured by a perspectives of B-COMPASS questionnaire of 5 questions, as well as focus groups
The study HCP perceptions questionnaire contains 5 questions about (i) ease of use of B-COMPASS, perceived (ii) impact of B-COMPASS cards on interaction with patients, (iii) impact of B-COMPASS patient description in supporting patients, (iv) intention to use B-COMPASS in the future, and (v) perceived benefit of B-COMPASS cards on patient engagement.
Likert scale with 7 response options, 1 = Fully disagree, 7 = Fully agree.
Measured: 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.
Cost-effectiveness impact of B-COMPASS on healthcare utilisation
Health-related quality of life will be assessed with EQ5D-5L and transformed into utilities to parametrize a cost-utility analysis of the B-COMPASS.
The EQ-5D-5L is a standardized measure of health-related quality of live that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from "no problems" to "extreme problems".
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Overall, this study has a Mixed Methods approach as both quantitative and qualitative data will be collected and merged to answer the SQs. A Randomised Controlled Trial (RCT) is chosen as study design for the quantitative data collection as the design is well suited for drawing conclusions from data about the effects of interventions (SQ 5). In addition, the remaining quantitative data needed to answer the SQs can be collected through this design. The qualitative data collection will be done by conducting individual and focus group interviews with HCPs and patients. The purpose of the qualitative data collection is to validate that the B-COMPASS groupings and identified needs of support are correct and to complement the quantitative data collected from the pilot studies. The qualitative data will provide insights into the perceptions, experiences, and preferences of the stakeholders involved in the intervention, as well as the contextual factors that may influence the B-COMPASS.
- Masking
- None (open label)
- Enrolment
- 6,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, PredictBy Research and Consulting, S.L, Pfizer, Merck KGaA, Darmstadt, Germany, Empirica, Centre for Research and Technology Hellas, Innovation Sprint, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Janssen Pharmaceutica N.V., Belgium, Novo Nordisk A/S, Servier Affaires Médicales, Takeda Pharmaceuticals International, Inc., Tilburg University
- Responsible party
- Principal investigator, Beatriz Merino, Technical University of Madrid
- Investigators
- Giuseppe Fico, Professor, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856902
- Sponsor's protocol ID
- BBAAMFIQHOACOH-GF-20241108
- Other IDs
- 101034369
- Acronym
- BEAMER
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe
- ClinicalTrials.gov ID
- NCT06856902
- Acronym / sponsor ID
- BEAMER / BBAAMFIQHOACOH-GF-20241108
- Conditions
- Cardiovascular Diseases, Endocrinology, Inmunology, Neurology, Oncology, Rare Diseases
- Keywords
- Digital health, adherence to treatment, healthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,190 participants (actual)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Collaborators
- University of Oslo, PredictBy Research and Consulting, S.L, Pfizer, Merck KGaA, Darmstadt, Germany, Empirica, Centre for Research and Technology Hellas, Innovation Sprint, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Janssen Pharmaceutica N.V., Belgium, Novo Nordisk A/S, Servier Affaires Médicales, Takeda Pharmaceuticals International, Inc., Tilburg University
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 4 Mar 2025 (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.
Lack of adherence to treatment is a widespread issue worldwide, which leads to higher healthcare utilisation rates and even premature death. While the level of adherence may differ based on the specific condition and treatment, studies estimate that approximately 50% of medications are not taken according to the prescribed instructions. In addition, adherence rates tend to decrease even further when the treatment requires a behavioural change. Literature reviews about factors that affect people's adherence show that it is challenging to predict whom can be considered to have adherent and non-adherent behaviours. In addition, the studies highlight that it is challenging to support a person to be adherent. Based on this knowledge the BEAMER project was established (Behavioural and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe). The overall goal of the project is to improve the quality of life of individuals, enhance healthcare accessibility and sustainability, thereby transforming the way healthcare stakeholders engage with patients to understand their condition and adherence levels throughout their healthcare journey. To address the overall goal, the BEAMER project has developed a disease agnostic model named "B-COMPASS: BEAMER-COmputational Model for Patient Adherence and Support Solutions". The aim of the B-COMPASS is to identify patients' needs and preferences which enables the creation of patient-specific supports, with the intention of improving their adherence to treatment within the heterogeneity of the different disease-areas and healthcare contexts. Based on the validated BEAMER questionnaire, the B-COMPASS predicts relative adherence and offers an elicitation process of patient needs and preferences to enable targeted supports to improve patient adherence. This results in an allocation of patients to different groups based on their needs and preferences. Overall, the B-COMPASS provides patient insights that will enable more effective design of patient support, most likely resulting in better patient experience, improved adherence and lower healthcare and societal costs.
So far, several activities from a technical and user perspective have already been conducted in the project to refine the B-COMPASS. This has been done by applying an iterative mixed method approach were both stakeholders (regulator, pharma, academic/research and small and medium-sized enterprises) and end users (patients, health providers and health systems) have been involved. Despite the finetuning of the B-COMPASS, the effectiveness of the B-COMPASS hinges on empirical investigations into the structural elements that impact patient behaviour and the identification of predictive factors that can assist healthcare providers' (HCP) and Research Leads in designing more effective treatment plans (the term HCPs/Research Lead include both the individuals and the institutions where care is delivered). Therefore, validation studies will be conducted to assess the B-COMPASS's performance in six therapeutic areas (cardiovascular, endocrinology, immunology, neurology, oncology and rare diseases) with patients recruited in at least Italy (FISM), Portugal (APDP and MEDIDA) Norway (AHUS), Spain (FHUNJ and FIIBAP), The Netherlands (WDO), and Germany (UDUS). The collected data will be used to evaluate the B-COMPASS's capacity to attend to a variety of needs and challenges for adherence.
Detailed description
The aim of the study is to validate the B-COMPASS in real-life settings. Overall, the purpose is to provide evidence 1) to validate the B-COMPASS (primary purpose), and 2) to demonstrate the effectiveness and implementability of the B-COMPASS (secondary purpose). The project will carry out the final iterative steps of refining the model, guided by the validation studies that have been conducted. This process will be based on evaluating the performance of the generic model across six selected therapeutic areas (cardiovascular, endocrinology, immunology, neurology, oncology and rare diseases). Study participants (patients and HCPs) will be recruited (at least) from Italy, Portugal, Norway, Spain, The Netherlands, and Germany, and the validation will evaluate the capacity to attend to a variety of needs and challenges for adherence to treatment.
Overall, the study has 8 Scientific Questions (SQs), where SQ 1-4 address the validity of the B-COMPASS (primary purpose) and SQ 5-8 address the effectiveness and implementability of the B-COMPASS (secondary purpose). The SQs are:
SQ 1 How accurately does the B-COMPASS predict the relative adherence to treatment for patients? SQ 2 How valid are the B-COMPASS groupings? SQ 3 How accurately are the patient support needs identified by the B-COMPASS? SQ 4 How reliable is the B-COMPASS over time? SQ 5 To what extent does the use of the B-COMPASS affect patient adherence to treatment? SQ 6 How do the patients perceive the received engagement with HCPs/Research Leads based on the B-COMPASS? SQ 7 How do HCPs/Research Leads perceive the B-COMPASS? SQ 8 How does the B-COMPASS impact the cost-effectiveness of healthcare utilisation?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Overall, this study has a Mixed Methods approach as both quantitative and qualitative data will be collected and merged to answer the SQs. A Randomised Controlled Trial (RCT) is chosen as study design for the quantitative data collection as the design is well suited for drawing conclusions from data about the effects of interventions (SQ 5). In addition, the remaining quantitative data needed to answer the SQs can be collected through this design. The qualitative data collection will be done by conducting individual and focus group interviews with HCPs and patients. The purpose of the qualitative data collection is to validate that the B-COMPASS groupings and identified needs of support are correct and to complement the quantitative data collected from the pilot studies. The qualitative data will provide insights into the perceptions, experiences, and preferences of the stakeholders involved in the intervention, as well as the contextual factors that may influence the B-COMPASS.
| Arm | Type | Receives |
|---|---|---|
| Control arm | No 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 arm | Active comparator | Behavioral: B-COMPASS implementationAt 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having the diagnosis of the pilot sites target groups described above as per clinical assessment or validated diagnosis criteria
- Having the age of the pilot sites target groups described above
- Having accepted to participate in the study and provided written informed consent
- Having the availability to participate on all study activities
Key exclusion criteria (1 listed)
- Individuals that do not fulfil ALL the inclusion criteria will be excluded to participate.
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 |
|---|---|---|
| B-COMPASS implementationThe 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. | Behavioural | Intervention arm |
Primary outcome
Accuracy of the B-COMPASS to predict adherence
Time frame: At first data collection
Predictive accuracy of B-COMPASS of adherence to treatment will be validated against TAP-Q in Visit 1 and other specific adherence measurements for all participants. The B-COMPASS is an adherence prediction model based on the BEAMER questionnaire, which is a questionnaire that contains 22 questions about subjective health experience and subjective awareness of health condition. Likert scale with 7 response options, 1 = Fully disagree, 7 = Fully agree (11 questions). Likert scale with 6 response options, 1 = Fully disagree, 6 = Fully agree (4 questions). Likert scale with 5 response options, 1 = Fully disagree, 5 = Fully agree (5 questions). Score on a 10-step ladder where step 1 = The day at the past 4 weeks I felt at my worst, step 10 = The day in the past 4 weeks I felt at my best (2 questions).
Validity of B-COMPASS groupings
Time frame: 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.
B-COMPASS groupings will be validated through the qualitative thematic analysis of interviews and focus groups with patients and HCPs in the intervention groups.
Accuracy of identification of patients' support needs
Time frame: 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.
The accuracy of the support needs identified by the B-COMPASS will also be analysed through qualitative analysis of focus groups and interviews with the intervention groups.
Reliability of B-COMPASS prediction over time
Time frame: 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.
The over-time reliability of the B-COMPASS will be measured by comparing its groupings and adherence prediction results at the first and second visits for the control group.
4 secondary outcomes
Extent to which the B-COMPASS affects patient adherence to treatment
Time frame: 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.
Patients' perceptions of the received engagement with HCPs based on B-COMPASS
Time frame: 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.
Perception of HCPs of the B-COMPASS
Time frame: 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.
Cost-effectiveness impact of B-COMPASS on healthcare utilisation
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Giuseppe Fico, Professor principal investigator
Universidad Politecnica de Madrid
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-COMPASS implementation in people with Cardiovascular Diseases and Endocrinology, run by Technical University of Madrid at 10 sites in 8 countries.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Portugal, Spain, Germany, Italy, Netherlands and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the B-COMPASS to predict adherence (time frame: At first data collection). The study lists 4 primary outcomes in all. 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 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.