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NCT Number: NCT02076555

Diabetes and Social Issues: Evaluation of a Diabetes Education Module

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Education - Diabetes and Social Issues

Behavioral

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Other

Registry information

Official study title

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

Acronym: PRIMO_Social

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2014
Registry last updated
Aug 9, 2019

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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