Creative Writing for Type 2 Diabetes Management

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT03678896
• Lead Sponsor: Associacao Protectora dos Diabeticos de Portugal

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.

Study Timeline

• Study Start: 2017-01-05
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-18
• Last Update Submitted: 2018-09-18
• Study First Posted: 2018-09-20
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin A1c levels at 6 months	Up to 6 months	Hemoglobin A1c is measured in mmol/mol units.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fat mass at 6 months	Up to 6 months	Fat mass is measured in Kg/m2
Change from baseline in weight at 6 months	Up to 6 months	Weight is measured in Kg.
Change from baseline in self-reported health	Up to 6 months	The 36-Item Short Form Survey is used to assess health perception. This scale comprises 36 items that are divided in 8 dimensions: 1) vitality; 2) physical functioning; 3) bodily pain; 4) general health perceptions; 5) physical role functioning; 6) emotional role functioning; 7) social role functioning; and 8) mental health. These subscales are transformed into a scale range from 0-100, in which lower scores indicate worse health perception.
Change from baseline in waist circumference at 6 months	Up to 6 months	Waist circumference is measured in cm
Change from baseline in self-reported quality of life at 6 months	Up to 6 months	The Diabetes Quality of Life Questionnaire (DQOL) is a self-report scale to assess quality of life. This scale comprises 13 items that are grouped in 4 subscales: 1) satisfaction with treatment, 2) impact of treatment, 3) worry about the future effects of diabetes, and 4) worry about social/vocational issues. A total score may be also computed from the sum of the 13 items. Higher scores indicate poorer quality of life, ranging from 13 to 65.
Change from baseline in self-reported locus of control at 6 months	Up to 6 months	Locus of control is measured using the Diabetes Specific Locus of Control Scale (DLOC), which is a self-report scale directed to diabetes patients. This scale comprises 13 items that are grouped in 3 subscales: 1) internal locus of control; 2) external locus of control; and 3) powerful other locus of control. Higher scores reflect higher locus of control in each of these dimensions.
Change from baseline in self-reported empathy at 6 months	Up to 6 months	Empathy is measured using a questionnaire - Jefferson Scale of Physician Empathy (JSPE-R), which comprises 9 items. Self-reported empathy levels are measured through a total score that is derived from the sum of the 9 items. The total score range from 9 to 63, in which higher scores depict higher empathy levels.
Change from baseline in self-reported group satisfaction at 6 months	Up to 6 months	Group satisfaction is measured using a questionnaire - Group Satisfaction Scale (GSS). The GSS assess 2 dimensions: 1) satisfaction with therapist subscale and 2) content/group process subscale. A total score may be also computed from the sum of the 12 items that comprise this scale. The scores range from 12 to 60, in which higher scores reflect higher satisfaction levels.