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

Case Report Form Clinical Trial

— CORD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02893059
• Other study ID #: PHRC/2014/CC-01
• Status: Withdrawn
• Start date: December 1, 2020
• Est. completion date: September 2021

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Case Report Form
• Declaration Bias
• Health Insurance Database

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of data collected in a patient diary and data stored in the database of health insurance		6 month