Diabetes and Social Issues: Evaluation of a Diabetes Education Module

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Education - Diabetes and Social Issues

• Registration Number: NCT02076555
• Lead Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Primary Completion: 2019-01
• Study Completion: 2019-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education - Diabetes and Social Issues	Education - Diabetes and Social Issues	Patients randomized to this arm, will participate immediately in the education module "Diabetes and Social Issues"

Primary Outcome Measures

Name	Time	Method
Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up	Baseline, 2-week follow-up , 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

Secondary Outcome Measures

Name	Time	Method
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 problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up	baseline, 2-week follow-up, 6-month follow-up	The PAID scale was specifically adapted to cover the topic "social issues". Psychometric quality was assessed in an independent study
Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up	baseline, 2-week follow-up, 6-month follow-up	HbA1c will be analyzed in a central laboratory.
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 depressive symptoms on the CES-D at the 2-week and 6-month follow-up	baseline, 2-week follow-up, 6-month follow-up

Trial Locations

Locations (4)

Research Institute of the Diabetes Academy Mergentheim (FIDAM); 🇩🇪 Bad Mergentheim, Germany

Zentrum für Diabetologie Bergedorf; 🇩🇪 Hamburg, Germany

Diabeteszentrum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany

Diabetologische Schwerpunktpraxis Neuss; 🇩🇪 Neuss, Germany