Diabetes and Social Issues: Evaluation of a Diabetes Education Module

Study Overview
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Brief Summary
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This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic diabetes and social issues. Primary outcome variable is diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

Detailed Description
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The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Official Title
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A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic Diabetes and Social Issues in a Randomized Controlled Trial

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Education - Diabetes and Social Issues


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intensive insulin treatment specific interest in Diabetes and Social Issues wish to participate in group education informed consent fluent in reading and speaking German language Exclusion Criteria: diabetes duration < 4 week severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) current treatment of a mental disease cognitive impairment dementia pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education - Diabetes and Social Issues<br>Patients randomized to this arm, will participate immediately in the education module Diabetes and Social Issues | Behavioral: Education - Diabetes and Social Issues<br>* Based on the treatment and education programme PRIMAS a problem-specific education module regarding Diabetes and Social Issues was created. The module covers specific and detailed aspects of the topic social issues such as driver licence, hypoglycemia when driving, and the pass for severly handicapped persons. With this module, a more comprehensive education of patients with specific interest is possible.<br>|
| No Intervention: Waiting-list control group<br>Patients in the control group will get the education with the education module after completion of the 6-month follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up | The Diabetes Empowerment Scale was specifically adjusted to cover the topic social issues. Psychometric criteria for these adjusted scale were evaluated in an independent study | Baseline, 2-week follow-up , 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up | The PAID scale was specifically adapted to cover the topic social issues. Psychometric quality was assessed in an independent study | baseline, 2-week follow-up, 6-month follow-up | 
| Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up | HbA1c will be analyzed in a central laboratory. | baseline, 2-week follow-up, 6-month follow-up | 
| Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up |  | baseline, 2-week follow-up, 6-month follow-up | 
| Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up |  | baseline, 2-week follow-up, 6-month follow-up | 
| Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up |  | baseline, 2-week follow-up, 6-month follow-up | 
| Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up |  | baseline, 2-week follow-up, 6-month follow-up | 
| Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up |  | baseline, 2-week follow-up, 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, education, randomized, prospective