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

October 12, 2010
May 31, 2012
September 2010
March 2012   (final data collection date for primary outcome measure)
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
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
  • 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
  • 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 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.

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

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: 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.
  • 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
    Intervention: Behavioral: PRIMAS
  • 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.
    Intervention: Behavioral: ZI Treatment and Education programme
Not Provided

*   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 > 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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
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
May 2012

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