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

NCT01220557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-08-17

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Forschungsinstitut der Diabetes Akademie Mergentheim

    lead OTHER

Principal Investigators

  • Norbert Hermanns, PhD · Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01220557 on ClinicalTrials.gov