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Two Narrative Medicine Interventions in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03365349
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):

November 17, 2017
December 7, 2017
December 7, 2017
February 1, 2012
February 28, 2013   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
comparison of the two groups concerning answers to qualitative interviews at T 3 months after the intervention [ Time Frame: 3 months after intervention ]
A psychologist conducted qualitative interviews according to a blinded process in a subgroup of 6 patients at T3 months, with a general inductive approach to capture all representations on diabetes and the session. Transcribed Interviews were analyzed regarding inductive coding and 2 independent investigators built and tested a coding schedule.
Same as current
Not Provided
Not Provided
 
Two Narrative Medicine Interventions in Type 1 Diabetes
Comparison Between Two Narrative Medicine Approaches in Type 1 Diabetes (T1D): a Prospective Randomized Study
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
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Type1diabetes
  • Other: participating in a session of "living theatre"
    participating to a session of "living theatre" which consists in writing a story about life with diabetes, which is then transformed to a script to be played by professional actors co-directed by the patient with the support of the Director to create a short play
  • Other: writing workshop
    one session consisting for the patient of writing a "Letter to his/her own diabetes" and then to read it to the group of patients and the healthcare providers.
  • Experimental: living theatre
    One session consisting for the patient of telling a story about his/her own life with diabetes , which is first written and then transformed to a script to be played by professional actors co-directed by the patient with the support of the Director to create a little play.
    Intervention: Other: participating in a session of "living theatre"
  • Active Comparator: writing workshop
    one session consisting for the patient of writing a "Letter to his/her own diabetes" and then to read it to the group of patients and the healthcare providers.
    Intervention: Other: writing workshop
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
August 1, 2013
February 28, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 1 diabetes

Exclusion Criteria:

  • no french language
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03365349
TDV
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Agnes Hartemann, Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP