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Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS) (PRIMAS)
This study has been completed.
Sponsor:
Forschungsinstitut der Diabetes Akademie Mergentheim
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
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Purpose
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 | Intervention |
|---|---|
| Type 1 Diabetes | Behavioral: PRIMAS Behavioral: DTTP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin
U.S. FDA Resources
Further study details as provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:
Primary Outcome Measures:
- 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:
- 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).
| Enrollment: | 162 |
| Study Start Date: | September 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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.
Eligibility| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01220557
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220557
Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Investigators
| Principal Investigator: | Norbert Hermanns, PhD | Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH) |
More Information
Publications:
| Responsible Party: | Norbert Hermanns, PhD, 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 |
Keywords provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:
|
Diabetes mellitus, education, self management |
Additional relevant MeSH terms:
|
Insulin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017