Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02893059

Acronym

CORD

Enrollment

Registered

2016-09-08

Start date

2020-12-01

Completion date

2021-09-01

Last updated

2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Case Report Form, Declaration Bias, Health Insurance Database

Brief summary

The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* incident and prevalent cases of patients with type I or type II diabetes. arthritis: * incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010). Renal failure : • incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not. Prostate cancer : • Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy). Breast cancer : • Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast). Colorectal cancer : • Incident cases of patients with colorectal cancer regardless of the stage at diagnosis (colonoscopy and polyp biopsy positive).

Exclusion criteria

\- The subject participates in an experimental study of research affecting the therapeutic management of the patient. * The subject is exclusion period determined by a previous study. * The subject is under judicial protection, guardianship or curatorship. * It is not possible to give informed about information * The subject does not read French and is not autonomous filling a questionnaire. * The patient has psychiatric disorders. * The subject is an emergency. * Monitoring between patient visits than 6 months.

Design outcomes

Primary

Measure	Time frame
comparison of data collected in a patient diary and data stored in the database of health insurance	6 month

Contacts

STUDY_DIRECTORchristel castelli, PhD

CHU Nimes

Outcome results