Two Narrative Medicine Interventions in Type 1 Diabetes

NCT03365349 | Completed

• 1 other identifier: TDV
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

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

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

  3 months after intervention

Study Arms (2)

living theatre

EXPERIMENTAL

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"

writing workshop

ACTIVE COMPARATOR

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

Interventions

participating in a session of "living theatre" OTHER

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

living theatre

writing workshop OTHER

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.

writing workshop

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• type 1 diabetes

You may not qualify if:

• no french language

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the diabetes department at the university hospital Pitié Salpetrière Paris

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 7, 2017
• Study Start: February 1, 2012
• Primary Completion: February 28, 2013
• Study Completion: August 1, 2013
• Last Updated: December 7, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share