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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):
Agnes Hartemann, Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Type1diabetes Other: participating in a session of "living theatre" Other: writing workshop Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Between Two Narrative Medicine Approaches in Type 1 Diabetes (T1D): a Prospective Randomized Study
Study Start Date : February 1, 2012
Actual Primary Completion Date : February 28, 2013
Actual Study Completion Date : August 1, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.
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

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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 1 diabetes

Exclusion Criteria:

  • no french language

Responsible Party: Agnes Hartemann, head of the diabetes department at the university hospital Pitié Salpetrière Paris, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03365349     History of Changes
Other Study ID Numbers: TDV
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases