Trial document





This trial has been registered retrospectively.
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  DRKS00004870

Trial Description

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Title

"Lebenschancen" with type 1 diabetes

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Trial Acronym

life chances

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Representative cross-sectional study on "life chances" among young adults (18 - 30 yrs) with type 1 diabetes diagnosed before 18 yrs of age.

Life chances include physical and psychological health and well-being, professional integration, social integration, partnership, children and satisfaction with outpatient care.

Young adults diagnosed before age of 6 yrs are compared with the ones diagnosed with diabetes between 6 and < 12 yrs and 12 - < 18 yrs of age. Furthermore the data of the young adults with diabetes are compared - if possible und not diabetes specific with the ones of the background population in Lower Saxony.

The questionnaires are completed anonymously during the out-patient visit in one of the 26 participating specialized diabetes practices.

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Brief Summary in Scientific Language

Assessment of metabolic and psychosocial outcomes and life chances in a representative sample of young adults in lower saxony.

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Organizational Data

  •   DRKS00004870
  •   2013/04/05
  •   [---]*
  •   yes
  •   Approved
  •   999-2011, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   E10 -  Insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Young adults with type 1 diabetes (age 18 - 30 yrs) with diabetes onset before 18th birthday once complete a structured questionnaire on therapy regimen, metabolic control, quality of life, psychosocial situation and satisfaction with therapy. Participants dignosed before 6 yrs of age are compared with those diagnosed between 6 -< 12 yrs of age and those diagnosed between 12 and < 18 yrs of age. These data willbe compared - if possible and not diabetes specific - with those of healthy controls of the same age range. (Statistics Lower Saxony).
  •   Control group: Statistical data of the background population (same age range, living in Lower saxony)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

One-time answering of the following structured questionnaires
1) on metabolic control
2) on insulin regimen
3) psychological well-being WHO-5 (WHO-Five Wellbeing index)
4) Depression / Anxiety (HADS) (Hospital Anxiety and Depression Scale- German version)
5) diabetesspecific burden (PAID) (Problem Areas in Diabetes Questionnaire)
6) satisfaction with therapy (5 Items; rating scale 1 - 6 on different aspects of diabetes long-term care)
7) sociodemographic data

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2011/10/03
  •   320
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   30   Years
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Additional Inclusion Criteria

Type 1 diabetes diagnosed before age of 18 yrs and age between 18 and 30 yrs. and diabetes out-patient care in Lower Saxony.

Controls: young adults (18-30 yrs) living in Lower Saxony

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Exclusion Criteria

no agreement with participation

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Addresses

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    • Deutsche Diabetes Stiftung
    • Staffelseestr. 6
    • 81477  München
    • Germany
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    • Medizinische Hochschule Hannover Medizinische Psychologie OE 5430
    • Ms.  Prof. Dr.  Karin  Lange 
    • Carl Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover Medizinische Psychologie OE 5430
    • Ms.  Prof. Dr.  Karin  Lange 
    • Carl Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Diabetes Stiftung
    • Staffelseestr. 6
    • 81477  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/04/03
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.