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Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus (RenewingHealth)

This study has been completed.
European Commission
Information provided by (Responsible Party):
Landeskrankenanstalten-Betriebsgesellschaft Identifier:
First received: April 17, 2012
Last updated: August 21, 2015
Last verified: April 2015
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.

Condition Intervention
Diabetes Mellitus Type 2
Other: Self-monitoring for patients with Diabetes mellitus type 2
Other: Nurse-monitoring for patients with Diabetes mellitus type 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Regions of Europe Working Together for Health (Renewing Health)

Further study details as provided by Landeskrankenanstalten-Betriebsgesellschaft:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Blood Pressure [ Time Frame: 12 months ]
  • Blood Lipids [ Time Frame: 12 months ]
  • Body Weight [ Time Frame: 12 months ]
  • Medication Changes [ Time Frame: 12 months ]
    Insulin, Change? -> Yes/No

  • Presence of Diabetic Complications [ Time Frame: 12 months ]
  • Number of Hospitalisations [ Time Frame: 12 months ]
    The number of inpatient stays comparing intervention and control group was conducted.

Enrollment: 193
Study Start Date: February 2010
Study Completion Date: February 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
treatment as usual
Experimental: Self-monitoring for patients with Diabetes mellitus type 2
Patients are self-monitoring and submitting their vital parameters.
Other: Self-monitoring for patients with Diabetes mellitus type 2
Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Experimental: Nurse-monitoring for patients with Diabetes mellitus type 2
Nurses are measuring and entering the vital parameters of the patients.
Other: Nurse-monitoring for patients with Diabetes mellitus type 2
Nurses are submitting the vital parameters of the patient via mobile device.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01580098

Klinikum Klagenfurt
Klagenfurt, Carinthia, Austria, 9020
LKH Laas
Kötschach, Carinthia, Austria, 9640
LKH Villach
Villach, Carinthia, Austria, 9500
Sponsors and Collaborators
European Commission
  More Information

Responsible Party: Landeskrankenanstalten-Betriebsgesellschaft Identifier: NCT01580098     History of Changes
Other Study ID Numbers: D250487
Study First Received: April 17, 2012
Results First Received: April 8, 2015
Last Updated: August 21, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on April 26, 2017