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Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives

NCT04150302 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2019-11-04

No results posted yet for this study

Summary

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.

Conditions

  • SBS - Short Bowel Syndrome

Interventions

OTHER

Exploratory interviews

Exploratory interviews to generate an interview guide

OTHER

Semi-directive interviews

Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation

OTHER

Delphi Process

Cotation of newly developed items pertinence on a 4 points likert scale.

OTHER

Think aloud interviews

Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.

OTHER

Psychometric validation

Psychometric properties study

Sponsors & Collaborators

  • Beaujon Hospital

    collaborator OTHER

  • Société Francophone Nutrition Clinique et Métabolisme

    collaborator OTHER

  • Central Hospital, Nancy, France

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-01-31
Completion
2021-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150302 on ClinicalTrials.gov