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

October 12, 2010
August 8, 2014
September 2010
March 2012   (final data collection date for primary outcome measure)
Changes in Glycemic Control Measured by A1c [ Time Frame: 6 month ] [ Designated as safety issue: No ]
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.
A1c [ Time Frame: 6 month after termination of educational interventions ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01220557 on ClinicalTrials.gov Archive Site
  • Diabetes Knowledge [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
  • Diabetes knowledge score [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    Roth, R., Kulzer, B. Teupe, B. & Borkenstein, M. (2000). Diabetes knowledge test: type 1 diabetes [Diabetes-Wissens-Test: Typ-I (DWT: Typ-I). Göttingen, Bern, Toronto, Seattle. Editor: Hogrefe Verlag.
  • Diabetes related distress score [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    Problem Areas in Diabetes Scales
  • Mental and physical composite score [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    SF 12 EQ D5 WHO 5
  • Depressive Symptoms [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    CES-D HADS
  • Hypoglycemia awareness [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
  • Apprisal of insulin treatment [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    Insulin treatment experience questionnaire(ITEQ)
  • Diabetes self-management [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    SDSCA Empowerment questionnaire IPAQ
Not Provided
Not Provided
 
Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
Prospective Randomized Trial for the Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
  • 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
  • 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
  • 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
    Intervention: Behavioral: PRIMAS
  • 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.
    Intervention: Behavioral: DTTP
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
March 2012
March 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01220557
NH062010
No
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim
Forschungsinstitut der Diabetes Akademie Mergentheim
Not Provided
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
Forschungsinstitut der Diabetes Akademie Mergentheim
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP