- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076542
Diabetes and Sports: Evaluation of a Diabetes Education Module (PRIMO_Sports)
August 7, 2019 updated by: Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Sports" in a Randomized Controlled Trial
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 sports".
Primary outcome variable is diabetes-specific empowerment regarding diabetes and sports.
Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
284
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bad Mergentheim, Germany, D-97980
- Research Institute of the Diabetes Academy Mergentheim (FIDAM)
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Hamburg, Germany, 21029
- Zentrum für Diabetologie Bergedorf
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Ludwigsburg, Germany, 71634
- Diabeteszentrum Ludwigsburg
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Neuss, Germany, 41462
- Diabetologische Schwerpunktpraxis Neuss
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Intensive insulin treatment
- specific interest in "Diabetes and Sports"
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education - Diabetes and Sports
Patients randomized to this arm, will participate immediately in the education module "Diabetes and Sports"
|
Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Sports" was created.
The module covers specific and detailed aspects of the topic "sports" such as insulin reduction, hypoglycemia awareness during physical activity, and blood glucose values prior to physical activity.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 "sports".
Psychometric criteria for these adjusted scale were evaluated in an independent study.
|
Baseline, 2-week follow-up , 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 "sports".
Psychometric quality was assessed in an independent study.
|
baseline, 2-week follow-up, 6-month follow-up
|
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.
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baseline, 2-week follow-up, 6-month follow-up
|
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
|
baseline, 2-week follow-up, 6-month follow-up
|
|
Change from baseline in physical activity on the International Physical Activity Questionnaire (IPAQ) at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
|
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
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baseline, 2-week follow-up, 6-month follow-up
|
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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
|
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
|
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
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baseline, 2-week follow-up, 6-month follow-up
|
|
Change from baseline in hypoglycemia awareness at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
|
baseline, 2-week follow-up, 6-month follow-up
|
|
Change from baseline in self-care behaviors at the 2-week and 6-month follow-up
Time Frame: baseline, 2-week follow-up, 6-month follow-up
|
baseline, 2-week follow-up, 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
February 28, 2014
First Submitted That Met QC Criteria
February 28, 2014
First Posted (Estimate)
March 3, 2014
Study Record Updates
Last Update Posted (Actual)
August 9, 2019
Last Update Submitted That Met QC Criteria
August 7, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NH022014_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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