Creative Writing for Type 2 Diabetes Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Close Reading and Creative Writing - CrewD Program. An Alternative Educational Method for Group Care Intervention in Type 2 Diabetes Management. A Randomized Trial

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: CrewD Program
* Behavioral: Classical structured education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CrewD Program approach<br>The aim was to increase education about the disease by using narrative skills through the CrewD Program. The sessions were conducted by two group leaders: a health professional and a literature professor manager of creative writing groups. Each session had a title, which parallels the classical structured educational approach (active comparator condition), which was known in advance by the subjects: a) Who I am in Diabetes?; b) Nutrition; c) The body where I live; d) Fears; e) Can attention change things?; and f) Roots. Team leaders directed a discussion of different texts used in the sessions with the participants focusing on their feelings and on how the texts relate to themselves and to their diabetes. Patients were encouraged to participate and freely express their opinion. | Behavioral: CrewD Program<br>* The CrewD Program - Creative reading and writing in Diabetes Program - is a Diabetes self-management education and support program to help people with Diabetes coping with the disease.<br>|
| Active Comparator: Classical structured education<br>Each session was 90 minutes long, with a similar internal structure in all of them. Each session included the following topics: a) Chronic Disease; b) Nutrition; c) Exercise; d) Complications; e) Self-management; and f) Diabetic foot. The sessions were held in a large room, in which the seats were arranged in circle. Every session was chaired by two healthcare providers, who worked as group leaders. There was a different visual presentation in each session, with relevant theoretical information. A board with sheets of paper was available for use in the discussion along with brochures about the disease. Patients were encouraged to actively participate and take part in group-problem solving. Group leaders guided the discussion by asking questions and encouraging the discussion. | Behavioral: Classical structured education<br>* The Classical educational approach consists in an educational method based on the presentation of relevant theoretical information to help people with Diabetes coping with the disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin A1c levels at 6 months | Hemoglobin A1c is measured in mmol/mol units. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in weight at 6 months | Weight is measured in Kg. | Up to 6 months | 
| Change from baseline in fat mass at 6 months | Fat mass is measured in Kg/m2 | Up to 6 months | 
| Change from baseline in waist circumference at 6 months | Waist circumference is measured in cm | Up to 6 months | 
| Change from baseline in self-reported quality of life at 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. | Up to 6 months | 
| Change from baseline in self-reported locus of control at 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. | Up to 6 months | 
| Change from baseline in self-reported empathy at 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. | Up to 6 months | 
| Change from baseline in self-reported group satisfaction at 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. | Up to 6 months | 
| Change from baseline in self-reported health | 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. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type II Diabetes, Educational methods, Disease self-management