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NCT02885129 Clinical Trial

Development of the General Scale Observance for Chronic Diseases

Chronic Diseases Clinical Trial

— EGOMAC  

Official title:
Development of the General Scale Observance for Chronic Diseases (EGOMAC)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02885129
Other study ID # PSS 2014/EGOMAC-GUILLEMIN/SR
Secondary ID
Status Completed
Phase N/A
First received August 23, 2016
Last updated August 13, 2017
Start date June 2014
Est. completion date April 2017

Study information
Verified date August 2017
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective is to assess the measurement characteristics (validity, reproducibility) and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology and rheumatology hospital and liberal and hospital oncology and Infectious disease, by following the evolution of patient compliance at D0 and D15.

The second objective is to assess the sensitivity to change of scale EGOMAC following developments compliance 3 months.

Description:

During a routine appointment (D0), the patient filled a newsletter and a questionnaire to complete.

The doctor collects medical informations for the case report form.

At the end of the first consultation (D0), an additional EGOMAC scale and a stamped envelope is delivered to the patient by asking him to fill that scale to 15 days and return it by Post Office (reproducibility study).

Finally, a new scale will be addressed to the patient at the end of 3 months, which will return by Post Office too (stability study).

Recruitment information / eligibility
Status Completed
Enrollment 397
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient age of 18 years

- from routine patient counseling

- with at least one of these diseases : heart failure, hypertension, coronary disease, type 2 diabetes, osteoarthritis of the knee or hip, osteoporosis, inflammatory rheumatism (rheumatoid arthritis, spondyloarthropathy), cancer ( with only non-hormonal oral anti cancer treatments) and HIV.

- patient can read the French language in order to complete the self -administered questionnaire

- patient agreeing to participate in the study

Exclusion Criteria:

- patient treated for more than 3 conditions mentioned in the inclusion criteria (

- patient receiving no drug prescription or recommendation of lifestyle or diet (for example consultationpurely diagnostic ).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Central hospital Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary EGOMAC questionnaire baseline
Primary Change in EGOMAC questionnaire 15 days
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