Diabetes and Social Issues: Evaluation of a Diabetes Education Module (PRIMO_Social)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor:
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:
NCT02076555
First received: February 28, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: Education - Diabetes and Social Issues

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Social Issues" in a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Education - Diabetes and Social Issues
Patients randomized to this arm, will participate immediately in the education module "Diabetes and Social Issues"
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076555

Contacts
Contact: Norbert Hermanns, PhD 0049 7931 594 553 hermanns@diabetes-zentrum.de

Locations
Germany
Research Institute of the Diabetes Academy Mergentheim (FIDAM) Recruiting
Bad Mergentheim, Germany, 97980
Contact: Norbert Hermanns, PhD       hermanns@diabetes-zentrum.de   
Principal Investigator: Bernhard Kulzer, PhD         
Sub-Investigator: Nikola Bergis-Jurgan, MSc         
Sub-Investigator: Dominic Ehrmann, MSc         
Zentrum für Diabetologie Bergedorf Recruiting
Hamburg, Germany, 21029
Contact: Jens Kröger, M.D.       diabeteszentrumhamburg@t-online.de   
Principal Investigator: Jens Kröger, M.D         
Diabeteszentrum Ludwigsburg Recruiting
Ludwigsburg, Germany, 71634
Contact: Jörg Gloyer, M.D       kontakt@diabeteszentrum-ludwigsburg.de   
Principal Investigator: Jörg Gloyer, M.D         
Diabetologische Schwerpunktpraxis Neuss Recruiting
Neuss, Germany, 41462
Contact: Rainer Betzholz, M.D       info@dr-betzholz.de   
Principal Investigator: Rainer Betzholz, M.D         
Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Investigators
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim
  More Information

No publications provided

Responsible Party: Norbert Hermanns, Head of the Research Institut Diabetes Academy Mergentheim, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT02076555     History of Changes
Other Study ID Numbers: NH022014_3
Study First Received: February 28, 2014
Last Updated: February 28, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Forschungsinstitut der Diabetes Akademie Mergentheim:
diabetes
education
randomized
prospective

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014