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

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ClinicalTrials.gov Identifier: NCT01220557
Recruitment Status : Completed
First Posted : October 14, 2010
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

Study Description
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Brief Summary:
This study is a randomized prospective trial with 6-month follow up. A non-inferiority hypothesis is tested. A new developed treatment and education programme for type 1 diabetic patients (PRIMAS) will be tested compared to an established treatment and education programme (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms, diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment, hypoglycemia awareness.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: PRIMAS Behavioral: DTTP Not Applicable

Detailed Description:
Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed PRIMAS programme or to an established education programme for type 1 diabetic patients (DTTP - Treatment and education programme for intensified insulin treatment) as an active comparator.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial for the Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
Study Start Date : September 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Behavioral: PRIMAS
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
Active Comparator: 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.
 Behavioral: DTTP
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.
Other Names:
  • The German Diabetes Teaching and Treatment Programme
  • ZI Treatment and Education Program for intensified insulin theapy


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Glycemic Control Measured by A1c [ Time Frame: 6 month ]
    Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.


Secondary Outcome Measures :
  1. Diabetes Knowledge [ Time Frame: 6 month ]
    To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.

  2. Hypoglycaemia Awareness Score [ Time Frame: 6 month ]
    The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.

  3. Diabetes Empowerment Score (DES) [ Time Frame: 6 month follow up ]
    Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.

  4. Summary of Diabetes Self-Care Activities (SDSCA) [ Time Frame: 6 month ]
    The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.

  5. Diabetes Distress Scale (DDS) [ Time Frame: 6 month follow up ]
    Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.

  6. CES-D Score [ Time Frame: 6 month follow up ]
    Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.

  7. Diabetes Self-Efficacy Scale [ Time Frame: 6 Month Follow up ]
    A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.

  8. Treatment Satisfaction / Problem Areas in Dealing With Diabetes [ Time Frame: 6 Month Follow up ]
    Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.

  9. Evaluation of the Diabetes Education Course [ Time Frame: 6 month Follow up ]
    Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

type 1 diabetes, diabetes duration > 4 weeks, age 18 - 75 years, BMI 20 - 40 kg/m², A1c 7 - 13 %, ability to understand, speak and write German language, written informed consent.

Exclusion criteria:

current treatment of psychological or psychiatric disorder, dementia or severe cognitive impairment, severe organic disease (e.g. terminal renal disease, cancer with poor prognosis), preventing a regular participation in the training course, pregnancy.

Contacts and Locations
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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): NCT01220557


Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Investigators
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
More Information
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Publications of Results:

Responsible Party: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT01220557     History of Changes
Other Study ID Numbers: NH062010
First Posted: October 14, 2010    Key Record Dates
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014
Last Verified: August 2014

Keywords provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:
Diabetes mellitus, education, self management

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs