Clinical trial

I-OPERA: A European Study Testing a New Way to Do Health Research.

Opening soon · Not applicable · 0 countries · Registry ID NCT07759544

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity (Disorder), Overweight , Obesity

Full registry criteria

Inclusion Criteria: * Age ≥18 years * Resident in England, France, or Germany * Self-reported height and weight corresponding to a calculated BMI ≥27 kg/m² Exclusion Criteria: * 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) * Participants whose HCPs are exclusively located outside the participant's country of residence, where applicable

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

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.Retrospective clinical data covering up to approximately five years prior to enrolment.

* 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 vi…

Study locations

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No public site location was included in this record. Check the original registry for updates.