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

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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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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:

Hermanns N, Kulzer B, Ehrmann D, Bergis-Jurgan N, Haak T. The effect of a diabetes education programme (PRIMAS) for people with type 1 diabetes: results of a randomized trial. Diabetes Res Clin Pract. 2013 Dec;102(3):149-57. doi: 10.1016/j.diabres.2013.10.009. Epub 2013 Oct 9.

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
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