Diabetes and Social Issues: Evaluation of a Diabetes Education Module (PRIMO_Social)
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Education - Diabetes and Social Issues
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes, education, randomized, prospective
Eligibility 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
Sites / Locations
- Research Institute of the Diabetes Academy Mergentheim (FIDAM)
- Zentrum für Diabetologie Bergedorf
- Diabeteszentrum Ludwigsburg
- Diabetologische Schwerpunktpraxis Neuss
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Education - Diabetes and Social Issues
Waiting-list control group
Arm Description
Patients randomized to this arm, will participate immediately in the education module "Diabetes and Social Issues"
Patients in the control group will get the education with the education module after completion of the 6-month follow-up
Outcomes
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
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
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
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
Change from baseline in quality of life on the WHO-5 at the 2-week and 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
Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up
Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up
Full Information
NCT ID
NCT02076555
First Posted
February 28, 2014
Last Updated
August 7, 2019
Sponsor
Forschungsinstitut der Diabetes Akademie Mergentheim
1. Study Identification
Unique Protocol Identification Number
NCT02076555
Brief Title
Diabetes and Social Issues: Evaluation of a Diabetes Education Module
Acronym
PRIMO_Social
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Forschungsinstitut der Diabetes Akademie Mergentheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
diabetes, education, randomized, prospective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education - Diabetes and Social Issues
Arm Type
Experimental
Arm Description
Patients randomized to this arm, will participate immediately in the education module "Diabetes and Social Issues"
Arm Title
Waiting-list control group
Arm Type
No Intervention
Arm Description
Patients in the control group will get the education with the education module after completion of the 6-month follow-up
Intervention Type
Behavioral
Intervention Name(s)
Education - Diabetes and Social Issues
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up
Description
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
Time Frame
Baseline, 2-week follow-up , 6-month follow-up
Secondary Outcome Measure Information:
Title
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
Description
The PAID scale was specifically adapted to cover the topic "social issues". Psychometric quality was assessed in an independent study
Time Frame
baseline, 2-week follow-up, 6-month follow-up
Title
Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up
Description
HbA1c will be analyzed in a central laboratory.
Time Frame
baseline, 2-week follow-up, 6-month follow-up
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Hermanns, PhD
Organizational Affiliation
Forschungsinstitut der Diabetes Akademie Mergentheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of the Diabetes Academy Mergentheim (FIDAM)
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Zentrum für Diabetologie Bergedorf
City
Hamburg
ZIP/Postal Code
21029
Country
Germany
Facility Name
Diabeteszentrum Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
71634
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis Neuss
City
Neuss
ZIP/Postal Code
41462
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Diabetes and Social Issues: Evaluation of a Diabetes Education Module
We'll reach out to this number within 24 hrs