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: May 31, 2012
Last verified: May 2012
  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 will be tested compared to an established treatment and education programme. Primary outcome variable is glycemic control in a 6-month follow up. Secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms, self care behavior, metabolic risk factors, quality of life, attitudes towards diabetes and insulin treatment.


Condition Intervention
Type 1 Diabetes
Behavioral: PRIMAS
Behavioral: ZI Treatment and Education programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:


Further study details as provided by Forschungsinstitut der Diabetes Akademie Mergentheim:

Primary Outcome Measures:
  • Improvement of 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


Secondary Outcome Measures:
  • Satisfaction with insulin treatment (ITEQ) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The Insulin Treatment Experience Questionnaire (ITEQ) is used to assess how insulin treatment affect patient treatment satisfaction.

  • Diabetes knowledge [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The DWT Type-1, a established German diabetes knowlegde score for patients with type 1 diabetes mellitus, and a new developed 11-item diabetes knowledge score, for patients with type 1 or type 2 diabetes and an intensified insulin therapy, was used to assess patients diabetes knowledge.

  • Hypoglycaemia unawareness Score [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The hypoglycemia unawareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness.

  • Diabetes Empowerment Score (DES) [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    The DES is a measure of diabetes-related psychosocial self-efficacy.

  • Summary of Diabetes self-care activities -Score (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.

  • International Physical Activity Questionnaire Score (IPAQ) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The International Physical Activity Questionnaire (IPAQ) measured sef reported physical activity.

  • Diabetes related distress scores (DDS) [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    The Diabetes Distress Scale (DDS) is ameasure for the assessment of emotional burdens in diabetes treatment.

  • CES-D Score [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]
    The CES-D (Center for Epidemiological Studies - Depression Scale) is an instrument for measuring number and severity of depressive symptoms.

  • WHO 5 Score and SF 12 Score [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Measures auf health related quality of life are the WHO Well-being Questionnaire (WHO-5) and the Health Survey Short Form (SF-12).

  • Diabetes Self-Efficacy Scale [ Time Frame: 6 Month Follow up ] [ Designated as safety issue: No ]
    Kempe, J., Hermanns, N., Kubiak, T., Kulzer, B., Haak T. (2002). Entwicklung eines Fragebogens zur Erfassung von Selbstmanagementfertigkeiten. Diabetes und Stoffwechsel, 11, Suppl. 1:144

  • Treatment Satisfaction / Problem areas in dealing with Diabetes [ Time Frame: 6 Month Follow up ] [ Designated as safety issue: No ]

    This questionnaire measures satisfaction with diabetes treatment and uncovers problems in dealing with diabetes.

    Kulzer, B., Bauer, U., Hermanns, N., Bergis, K.H. (1995). Entwicklung eines Problemfragebogens für Diabetiker zur Identifikation von Schwierigkeiten im Umgang mit der Krankheit. Ver-haltenstherapie, 5(Suppl.1), A72.


  • Evaluation of the diabetes education course [ Time Frame: 6 month Follow up ] [ Designated as safety issue: No ]
    A self-constructed scale was used to assess patients satisfaction with the diabetes education program


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
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: ZI Treatment and education programme
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: ZI Treatment and Education programme
Established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.

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 (Treatment and education programme for intensified insulin treatment) as an active comparator.

Inclusion criteria:

type 1 diabetes diabetes duration > 4 weeks age 18 - 75 years BMI 20 - 40 kg/m² A1c > 6.9% and < 13.1% no structured diabetes education during the last 12 months wish to participate in a group education fluent in reading and speaking German language informed consent

Exclusion criteria:

severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) current treatment of a mental disease Cognitive impairment - dementia pregnancy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

type 1 diabetes diabetes duration > 4 weeks age 18 - 75 years BMI 20 - 40 kg/m² A1c > 6.9% and < 13.1% no structured diabetes education during the last 12 months wish to participate in a group education fluent in reading and speaking German language informed consent

Exclusion Criteria:

severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) current treatment of a mental disease Cognitive impairment - dementia pregnancy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220557

Locations
Germany
Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
Bad Mergentheim, Germany, D-97980
Sponsors and Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
Investigators
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
  More Information

No publications provided

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
Last Updated: May 31, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Forschungsinstitut der Diabetes Akademie Mergentheim:
Diabetes mellitus, education, self management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014