BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe
New trial aims to improve treatment adherence using a personalized digital tool
Plain English Summary
BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe is a Not Applicable clinical trial sponsored by Technical University of Madrid studying Cardiovascular Diseases, Endocrinology, Inmunology, Neurology, Oncology, Rare Diseases. This study tests a new digital tool called B-COMPASS to help patients stick to their treatment plans. It is for individuals with various chronic conditions, including heart disease, diabetes, and neurological disorders. Participants will receive standard care plus personalized support based on the B-COMPASS tool, which may involve educational materials and discussions with healthcare providers. The alternative is to continue with standard treatment without the B-COMPASS personalized support. The trial aims to enroll 3100 participants.
Official 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 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
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have a diagnosed condition relevant to the study sites and are willing to participate fully. Individuals who do not meet all the inclusion criteria will not be able to participate. Age requirements are specific to the pilot sites and their target patient groups. You must be able to provide informed consent and commit to all study activities. This trial is studying Cardiovascular Diseases, Endocrinology, Inmunology, Neurology, Oncology, Rare Diseases, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how well the B-COMPASS tool can accurately predict if a patient will follow their treatment, group patients based on their needs, and identify what kind of support they re The specific primary outcome measures are: Accuracy of the B-COMPASS to predict adherence (At first data collection); Validity of B-COMPASS groupings (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 (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 (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.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses the significant problem of patients not following their prescribed treatments, which can lead to worse health outcomes and increased healthcare costs, by offering a personalized s This research targets Cardiovascular Diseases, Endocrinology, Inmunology, Neurology, Oncology, Rare Diseases, where improved treatment options are needed.
Investor Insight
This project signals a growing investment in digital health solutions for chronic disease management, aiming to improve patient outcomes and reduce healthcare system burden, with potential for broad a The large enrollment target of 3100 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if the B-COMPASS tool is suitable for your specific condition and treatment plan. Understand how the B-COMPASS will be used to tailor support for you, whether through educational materials or discussions. Be prepared for regular check-ins or data collection as part of the study, which may occur in person or by phone. This trial is currently recruiting participants. The trial is being conducted at 10 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 3,100 participants
Interventions
- BEHAVIORAL: B-COMPASS implementation — 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.
Primary Outcomes
- Accuracy of the B-COMPASS to predict adherence (At first data collection)
- Validity of B-COMPASS groupings (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 (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 (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
- Extent to which the B-COMPASS affects patient adherence to treatment (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 (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 (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 (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.)
Full Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Individuals that do not fulfil ALL the inclusion criteria will be excluded to participate.
Trial Locations
- UDUS - Heinrich-Heine-University Duesseldorf, Düsseldorf, Germany
- FISM - Italian Multiple Sclerosis Foundation, Genova, Italy
- WDO - World Duchenne Organization, Veenendaal, Netherlands
- AHUS - Akershus University Hospital, Lørenskog, Akershus, Norway
- APDP Diabetes Portugal, Lisbon, Portugal
- MEDCIDS - Departamento de Medicina da Comunidade Informação e Decisão em Saúde, Porto, Portugal
- UMCM - University Medical Center Maribor, Maribor, Slovenia
- FHUNJ - Fundación para la Investigación Biomédica del Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- FIIBAP - Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria, Madrid, Spain
- KCRI - Kilimanjaro Clinical Research Institute, Moshi, Tanzania
Frequently Asked Questions
What is clinical trial NCT06856902?
NCT06856902 is a Not Applicable INTERVENTIONAL study titled "BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe." It is currently recruiting and is sponsored by Technical University of Madrid. The trial targets enrollment of 3100 participants.
What conditions does NCT06856902 study?
This trial investigates treatments for Cardiovascular Diseases, Endocrinology, Inmunology, Neurology, Oncology, Rare Diseases. The primary condition under study is Cardiovascular Diseases.
What treatments are being tested in NCT06856902?
The interventions being studied include: B-COMPASS implementation (BEHAVIORAL). 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.
What does Not Applicable mean for NCT06856902?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06856902?
This trial is currently "Recruiting." It started on 2025-03-01. The estimated completion date is 2026-09-30.
Who is sponsoring NCT06856902?
NCT06856902 is sponsored by Technical University of Madrid. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06856902?
The trial aims to enroll 3100 participants. The trial is currently recruiting and accepting new participants.
How is NCT06856902 designed?
This is a interventional study, uses randomized allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06856902?
The primary outcome measures are: Accuracy of the B-COMPASS to predict adherence (At first data collection); Validity of B-COMPASS groupings (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 (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 (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.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06856902 being conducted?
This trial is being conducted at 10 sites, including Düsseldorf; Genova; Veenendaal; Lørenskog, Akershus and 6 more sites (Germany, Italy, Netherlands).
Where can I find official information about NCT06856902?
The official record for NCT06856902 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06856902. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06856902 testing in simple terms?
This study tests a new digital tool called B-COMPASS to help patients stick to their treatment plans. It is for individuals with various chronic conditions, including heart disease, diabetes, and neurological disorders.
Why is this trial significant?
This trial addresses the significant problem of patients not following their prescribed treatments, which can lead to worse health outcomes and increased healthcare costs, by offering a personalized s
What are the potential risks of participating in NCT06856902?
The main risk is that the B-COMPASS tool may not accurately predict adherence or identify your support needs. Potential side effects are minimal and mainly related to the time and effort required for participation. There's a possibility that the personalized support may not lead to improved adherence for everyone. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06856902?
Ask your doctor if the B-COMPASS tool is suitable for your specific condition and treatment plan. Understand how the B-COMPASS will be used to tailor support for you, whether through educational materials or discussions. Be prepared for regular check-ins or data collection as part of the study, which may occur in person or by phone. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06856902 signal from an investment perspective?
This project signals a growing investment in digital health solutions for chronic disease management, aiming to improve patient outcomes and reduce healthcare system burden, with potential for broad a This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive standard care plus personalized support based on the B-COMPASS tool, which may involve educational materials and discussions with healthcare providers. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.