Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier:
NCT01220557
First received: October 12, 2010
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: August 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Interventions: Behavioral: PRIMAS
Behavioral: DTTP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The participants were recruited in 23 outpatient study centres, which were located all over Germany. A study centre was defined as a medical practice run by a diabetologist and a diabetes educator or diabetes nurse.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PRIMAS Group PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
Control Group The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.

Participant Flow:   Overall Study
    PRIMAS Group     Control Group  
STARTED     81     79  
COMPLETED     75 [1]   74 [1]
NOT COMPLETED     6     5  
Lost to Follow-up                 5                 3  
attended less than 6 lessons                 1                 2  
[1] per protocol analysis including patients which participated in at least 6 out of 12 lessons.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PRIMAS Group PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
Control Group The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
Total Total of all reporting groups

Baseline Measures
    PRIMAS Group     Control Group     Total  
Number of Participants  
[units: participants]
  81     79     160  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     74     77     151  
>=65 years     7     2     9  
Age  
[units: years]
Mean ± Standard Deviation
  45.9  ± 13.8     45.1  ± 13.4     45.5  ± 13.5  
Gender  
[units: participants]
     
Female     31     39     70  
Male     50     40     90  
Region of Enrollment  
[units: participants]
     
Germany     81     79     160  



  Outcome Measures

1.  Primary:   Changes in Glycemic Control Measured by A1c   [ Time Frame: 6 month ]

2.  Secondary:   Diabetes Knowledge   [ Time Frame: 6 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Hypoglycaemia Awareness Score   [ Time Frame: 6 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Diabetes Empowerment Score (DES)   [ Time Frame: 6 month follow up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Summary of Diabetes Self-Care Activities (SDSCA)   [ Time Frame: 6 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Diabetes Distress Scale (DDS)   [ Time Frame: 6 month follow up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   CES-D Score   [ Time Frame: 6 month follow up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Diabetes Self-Efficacy Scale   [ Time Frame: 6 Month Follow up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Treatment Satisfaction / Problem Areas in Dealing With Diabetes   [ Time Frame: 6 Month Follow up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Evaluation of the Diabetes Education Course   [ Time Frame: 6 month Follow up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Norbert Hermanns, PhD
Organization: Forschungsinstitut der Diabetes Akademie Mergentheim
phone: +49 7931 594 ext 553
e-mail: hermanns@diabetes-zentrum.de


Publications of Results:

Responsible Party: Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT01220557     History of Changes
Other Study ID Numbers: NH062010
Study First Received: October 12, 2010
Results First Received: August 8, 2014
Last Updated: August 8, 2014
Health Authority: Germany: Ethics Commission