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Completed

NCT Number: NCT03365349

Two Narrative Medicine Interventions in Type 1 Diabetes

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

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Key information

Conditions

Type1diabetes

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes

Exclusion criteria

  • no french language

Treatment and study plan

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

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 7, 2017
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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