Clinical trial NCT03678896: Creative Writing for Type 2 Diabetes Management
Official title: Close Reading and Creative Writing - CrewD Program. An Alternative Educational Method for Group Care Intervention in Type 2 Diabetes Management. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Type II Diabetes
Educational methods
Disease self-management
Lead sponsor: Associacao Protectora dos Diabeticos de Portugal
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is related to the development of a new model of Group Care for patients with Diabetes - the CrewD Program, incorporating close reading and creative writing in group education. A randomized trial was designed to evaluate this intervention.

Detailed description: A structured educational model for type 2 diabetic patients using Group Care is currently being used in several institutions for help managing diabetes in these patients. In this study, this model was adjusted by introducing literary texts and using narrative skills. A randomized trial was designed to determine whether group dynamic strategies using narrative and reading produce the same positive outcomes as a conventional group approach. A total of 49 patients with type 2 Diabetes were randomized to two different Group Care dynamics, one "control group", with a classical structured educational approach and another, "intervention group", with close reading and creative writing. Evaluation included anthropometrical measures, A1c and questionnaires for psychological evaluation.

Eligibility criteria: Inclusion Criteria:

* Only patients with type 2 diabetes of \>1 year known duration, aged \< 85 years were included in the intervention.

Exclusion Criteria:

* Patients that did not complete the four assessments.

Primary outcomes:
measure: Change from baseline in hemoglobin A1c levels at 6 months
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change from baseline in weight at 6 months
timeFrame: Up to 6 months
measure: Change from baseline in fat mass at 6 months
timeFrame: Up to 6 months
measure: Change from baseline in waist circumference at 6 months
timeFrame: Up to 6 months
measure: Change from baseline in self-reported quality of life at 6 months
timeFrame: Up to 6 months
measure: Change from baseline in self-reported locus of control at 6 months
timeFrame: Up to 6 months
measure: Change from baseline in self-reported empathy at 6 months
timeFrame: Up to 6 months
measure: Change from baseline in self-reported group satisfaction at 6 months
timeFrame: Up to 6 months
measure: Change from baseline in self-reported health
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Associacao Protectora dos Diabeticos de Portugal
name: João Raposo, M.D.
role: STUDY_CHAIR
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