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Clinical Trials/NCT03365349
NCT03365349
Completed
Not Applicable

Comparison Between Two Narrative Medicine Approaches in Type 1 Diabetes (T1D): a Prospective Randomized Study

Assistance Publique - Hôpitaux de Paris0 sites87 target enrollmentFebruary 1, 2012
ConditionsType1diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type1diabetes
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
87
Primary Endpoint
Change from baseline IPQR (Illness Perception Questionnaire) score at 3 months
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

a randomized prospective study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course

Detailed Description

This randomized prospective pilot study aims at comparing the impact of a "living theater" session with a simple "writing workshop " on emotional distress (Problem Areas in Diabetes Questionnaire PAID) and illness perception ( Illness Perception Questionnaire IPQR) during a 5 day education course on Functional Insulin Therapy (FIT). Questionaries at T0 (course day 1 ) and T1 (3 months later). qualitative interviews in a sub group of patients random G1 and G2 subgroup at T1, with a general inductive approach to capture all representations

Registry
clinicaltrials.gov
Start Date
February 1, 2012
End Date
August 1, 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Agnes Hartemann

head of the diabetes department at the university hospital Pitié Salpetrière Paris

Assistance Publique - Hôpitaux de Paris

Eligibility Criteria

Inclusion Criteria

  • type 1 diabetes

Exclusion Criteria

  • no french language

Outcomes

Primary Outcomes

Change from baseline IPQR (Illness Perception Questionnaire) score at 3 months

Time Frame: 3 months after intervention

Illness Perception Questionnaire (IPQR) There is no total score for IPQR Nine subscales are reported for IPQR. High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition. High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition. Minimal and maximal score are respectively 0 and 14 for identity, 0 and 30 for timeline, consequences, personal control, and emotional representations, 0 and 25 for treatment control and illness coherence illness, 0-20 for timeline cyclical

Secondary Outcomes

  • comparison of the two groups concerning answers to qualitative interviews at T 3 months after the intervention(3 months after intervention)

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