Cardiovascular Diseases, Endocrinology, Inmunology, Neurology, Oncology, Rare Diseases
Conditions
Keywords
Digital health, adherence to treatment, healthcare
Brief 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 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?
Interventions
BEHAVIORALB-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.
Sponsors
Technical University of Madrid
University of Oslo
PREDICTBY RESEARCH AND CONSULTING S.L.
Pfizer
Merck KGaA, Darmstadt, Germany
Empirica
Centre for Research and Technology Hellas (CERTH)
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 design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Considering the nature of the intervention, it is not possible to blind participants or health care providers.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the B-COMPASS to predict adherence | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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". |
Countries
Germany, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Tanzania
Contacts
CONTACTGiuseppe Fico, Professor
CONTACTBeatriz Merino, PhD
PRINCIPAL_INVESTIGATORGiuseppe Fico, Professor
Universidad Politecnica de Madrid
Outcome results
None listed