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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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SBS - Short Bowel Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Exploratory interviews

Exploratory interviews to generate an interview guide

Intervention Type OTHER

Semi-directive interviews

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

Intervention Type OTHER

Delphi Process

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

Intervention Type 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.

Intervention Type OTHER

Psychometric validation

Psychometric properties study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with SBS defined by a hail length remaining in post-duodenal \< 2 meters
* Patients with intestinal insufficiency, i.e. chronic malabsorption requiring energetic and/or hydro-electrolytic intravenous support for more than 6 months
* Patients with a period of at least 6 months after the establishment of the SBS
* Patients who has already had a return home after the establishment of the SBS for a period of at least 3 months