Clinical trial NCT01220557: Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
Official title: Prospective Randomized Trial for the Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Diabetes mellitus, education, self management
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Changes in Glycemic Control Measured by A1c
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Diabetes Knowledge
timeFrame: 6 month
measure: Hypoglycaemia Awareness Score
timeFrame: 6 month
measure: Diabetes Empowerment Score (DES)
timeFrame: 6 month follow up
measure: Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: 6 month
measure: Diabetes Distress Scale (DDS)
timeFrame: 6 month follow up
measure: CES-D Score
timeFrame: 6 month follow up
measure: Diabetes Self-Efficacy Scale
timeFrame: 6 Month Follow up
measure: Treatment Satisfaction / Problem Areas in Dealing With Diabetes
timeFrame: 6 Month Follow up
measure: Evaluation of the Diabetes Education Course
timeFrame: 6 month Follow up
Other outcomes:
Locations:
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
name: Norbert Hermanns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.