NCT04150302|Unknown
Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives
ARTEMIS_GC
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ARTEMIS_GC
Sponsor study identifier
observational
250
1 country
1
Study Start
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Today, patients express a very strong need to take into account the consequences of their disease and its treatments in their therapeutic follow-up. It is therefore essential to better understand the needs, expectations and values of patients with SBS in order to better understand the impact of the disease on their lives, and thus improve the conditions for medical, social, psychological and technical care. The clinical expertise of health professionals and meetings with patient associations demonstrate the major gap between the parameters taken into account by physician to evaluate the evolution of the SBS and the day-to-day experience of the disease perceived by the patient. The objective of the ARTEMIS-GC study is to develop and validate an instrument to measure the impact of SBS and its treatments on daily life from the perspective of patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 23, 2019
Actual (reported)November 4, 2019
Actual (reported)January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Scale calibration of the new developped questionnaire
Calibration measure
about 30 minutes
Structure of the new developped questionnaire
Structure identification
about 30 minutes
Convergence proprieties of the new developped questionnaire
Convergence evaluation
about 30 minutes
Reproducibility of the new developped questionnaire
Test of reproducibility
Up to 8 days
Exploratory interviews to generate an interview guide
Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation
Patients over 18 years with SBS for more than 6 months and returned home for at least 3 months.
Beaujon Hospital
Paris, France
First Submitted
September 23, 2019
First Posted
November 4, 2019
Study Start
January 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2020
Estimated (date passed)Cotation of newly developed items pertinence on a 4 points likert scale.
Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.
Psychometric properties study
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 4, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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