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Trial record 2 of 2903 for:    diabetes | Recruiting, Not yet recruiting, Available Studies

Diabetes and Sports: Evaluation of a Diabetes Education Module (PRIMO_Sports)

This study is currently recruiting participants.
Verified February 2017 by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT02076542
First Posted: March 3, 2014
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
  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 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.

Condition Intervention
Diabetes Mellitus Behavioral: Education - Diabetes and Sports

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multi-center Evaluation of a Diabetes Education Module Specifically Addressing the Topic "Diabetes and Sports" in a Randomized Controlled Trial

Further study details as provided by Norbert Hermanns, 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 ]
    The Diabetes Empowerment Scale was specifically adjusted to cover the topic "sports". 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 ]
    The PAID scale was specifically adapted to cover the topic "sports". 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 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Education - Diabetes and Sports
Patients randomized to this arm, will participate immediately in the education module "Diabetes and Sports"
Behavioral: Education - 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076542


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, D-97980
Contact: Norbert Hermanns, PhD    0049 7931 594 ext 553    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

Responsible Party: Norbert Hermanns, Head of the Research Institut Diabetes Academy Mergentheim, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT02076542     History of Changes
Other Study ID Numbers: NH022014_1
First Submitted: February 28, 2014
First Posted: March 3, 2014
Last Update Posted: February 14, 2017
Last Verified: February 2017

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

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