- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03365349
Two Narrative Medicine Interventions in Type 1 Diabetes
December 1, 2017 updated by: Agnes Hartemann, Assistance Publique - Hôpitaux de Paris
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
87
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 1 diabetes
Exclusion Criteria:
- no french language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
February 28, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
November 17, 2017
First Submitted That Met QC Criteria
December 1, 2017
First Posted (Actual)
December 7, 2017
Study Record Updates
Last Update Posted (Actual)
December 7, 2017
Last Update Submitted That Met QC Criteria
December 1, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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