Diabetes and Social Issues: Evaluation of a Diabetes Education Module

Overview

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.

Full Title of Study: “A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic “Diabetes and Social Issues” in a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2019

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.

Interventions

  • Behavioral: Education – Diabetes and Social Issues
    • 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.

Arms, Groups and Cohorts

  • Experimental: Education – Diabetes and Social Issues
    • Patients randomized to this arm, will participate immediately in the education module “Diabetes and Social Issues”
  • No Intervention: Waiting-list control group
    • Patients in the control group will get the education with the education module after completion of the 6-month follow-up

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up
    • Time Frame: 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 Measures

  • 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: baseline, 2-week follow-up, 6-month follow-up

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Forschungsinstitut der Diabetes Akademie Mergentheim
  • Provider of Information About this Clinical Study
    • Principal Investigator: Norbert Hermanns, Head of the Research Institut Diabetes Academy Mergentheim – Forschungsinstitut der Diabetes Akademie Mergentheim
  • Overall Official(s)
    • Norbert Hermanns, PhD, Principal Investigator, Forschungsinstitut der Diabetes Akademie Mergentheim

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