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Clinical Trials/NCT01580098
NCT01580098
Completed
Not Applicable

Regions of Europe Working Together for Health (Renewing Health)

Landeskrankenanstalten-Betriebsgesellschaft3 sites in 1 country193 target enrollmentFebruary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
Landeskrankenanstalten-Betriebsgesellschaft
Enrollment
193
Locations
3
Primary Endpoint
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
February 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Landeskrankenanstalten-Betriebsgesellschaft
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • T2DM diagnosed \> 3 months prior to the enrollment
  • HbA1c \>= 6,5 %
  • Capability of filling questionnaires by their own language
  • Being able to use the devices provided
  • Being cognitively able to participate

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire

Time Frame: 12 months

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests.

HbA1c

Time Frame: 12 months

HbA1c was taken at the beginning of the study and after 12 months.

Secondary Outcomes

  • Blood Pressure(12 months)
  • Blood Lipids(12 months)
  • Body Weight(12 months)
  • Medication Changes(12 months)
  • Presence of Diabetic Complications(12 months)
  • Number of Hospitalisations(12 months)

Study Sites (3)

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