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

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
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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
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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.
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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:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Principal Investigator: | Norbert Hermanns, PhD | Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH) |
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 |