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NCT Number: NCT01220557

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRIMAS

Behavioral

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

DTTP

Behavioral

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

Primary outcomes

  1. Changes in Glycemic Control Measured by A1c

    Time frame: Baseline and 6 months

    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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Forschungsinstitut der Diabetes Akademie Mergentheim

Other

Registry information

Official study title

Prospective Randomized Trial for the Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)

Acronym: PRIMAS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2010
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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