I-OPERA: A European Study Testing a New Way to Do Health Research.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIQVIA RDS Spain, SL
About this trial
The goal of this observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. This approach allows participants to take part remotely and to help researchers access their medical records using their data access rights, while also providing information directly through an online questionnaire.
The main questions it aims to answer are:
1. Can medical records be successfully obtained through participant-authorized data subject access requests (DSARs), and how long does the process take? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) 2. How well do healthcare providers comply with requests for medical records? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest. Therefore, their healthcare providers are not contacted.) 3. Is the information collected through this approach complete and of sufficient quality for research purposes? 4. How closely does information reported by participants match the information contained in their medical records? 5. Are there differences in outcomes between countries and regions? Researchers will also explore the demographic, clinical and socio-economic characteristics of participants, assess health-related quality of life, evaluate experiences related to "food noise", and compare quality-of-life results across countries.
There is no comparison group or study treatment, as this is an observational study.
Participants will:
* Provide electronic informed consent to participate in the study. * Authorize requests for their medical records using their legal right to access personal health information (DSAR). (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) * Complete an online questionnaire about their health, quality of life, and experiences related to obesity. * Allow researchers to combine information from questionnaire with data obtained from their medical records. * Participate entirely remotely through the IQVIA Health Research Space (HRS) platform, with no study site visits required.
Participation lasts for up to 90 days and includes completion of questionnaire and the medical record retrieval process. The study plans to enroll approximately 105 participants, with around 35 participants in each participating country.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Resident in England, France, or Germany
Self-reported height and weight corresponding to a calculated BMI ≥27 kg/m²
Disqualifiers
Unable to provide electronic informed consent form (ICF)
Unable to name at least one HCP involved in their care and the affiliated institution, where applicable
Unwilling to authorise medical records access via DSAR (where applicable) or direct upload
Unable to complete online surveys (approximately 30 minutes) on own device (computer, smartphone, or tablet)
Trial population
Participants will be recruited remotely in England, France and Germany by IQVIA Global Perspectives through patient advocacy groups, research recruitment services (OneKey), and existing patient panels (IQVIA Ltd's Global Perspectives Patient Community). Potential participants will receive an email containing a plain-language description of the study and a link to a screening platform. After providing a brief study-specific consent, they will complete a short pre-screening questionnaire. Those who appear eligible and wish to continue will receive an invitation to the IQVIA Health Research Space (HRS) platform. There, participants will complete the electronic informed consent process, provide authorization for medical record access (where applicable), and undergo eligibility assessment based on the study inclusion and exclusion criteria. Only participants who meet all eligibility requirements and provide informed consent will be enrolled in the study.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
This study will collect a focused set of self-reported descriptive and participant-reported measures relevant to the real-world experience of adults with obesity.
* Demographics (age, sex, city and country of residence) * Anthropometrics (weight, height, waist circumference and hip circumference) * PROs: * HRQoL will be assessed using the SF-36 (including physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health) * 'Food noise' will be captured with the Thrive Food Noise Assessment * Lifestyle and behavioural factors habits (dietary habits and physical activity, smoking, alcohol consumption) * Social determinants of health (key social and environmental factors, including economic status, education and health literacy) * Treatment Patterns: data on current and past obesity-related treatments will be collected via participant self-report and medical record abstraction * HCRU (e.g., hospitalisations, outpatient visits) will be collected to describe the burden associated with living with obesity
Time frame
Retrospective clinical data covering up to approximately five years prior to enrolment.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IQVIA RDS Spain, SL
Lead sponsor
IQVIA Solutions Portugal, Unipessoal Lda
Collaborator
Source ClinicalTrials.gov
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