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Completed

NCT Number: NCT03678896

Creative Writing for Type 2 Diabetes Management

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CrewD Program

Behavioral

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.

Classical structured education

Behavioral

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.

Primary outcomes

  1. Change from baseline in hemoglobin A1c levels at 6 months

    Time frame: Up to 6 months

    Hemoglobin A1c is measured in mmol/mol units.

Secondary outcomes

  1. Change from baseline in weight at 6 months

    Time frame: Up to 6 months

    Weight is measured in Kg.

  2. Change from baseline in fat mass at 6 months

    Time frame: Up to 6 months

    Fat mass is measured in Kg/m2

  3. Change from baseline in waist circumference at 6 months

    Time frame: Up to 6 months

    Waist circumference is measured in cm

  4. Change from baseline in self-reported quality of life at 6 months

    Time frame: 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.

  5. Change from baseline in self-reported locus of control at 6 months

    Time frame: 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.

  6. Change from baseline in self-reported empathy at 6 months

    Time frame: 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.

  7. Change from baseline in self-reported group satisfaction at 6 months

    Time frame: 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.

  8. Change from baseline in self-reported health

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Associacao Protectora dos Diabeticos de Portugal

Other

Registry information

Official study title

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

Acronym: CrewD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2018
Registry last updated
Sep 20, 2018

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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