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

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ClinicalTrials.gov Identifier: NCT01580098
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Landeskrankenanstalten-Betriebsgesellschaft

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Other: Self-monitoring for patients with Diabetes mellitus type 2 Other: Nurse-monitoring for patients with Diabetes mellitus type 2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Regions of Europe Working Together for Health (Renewing Health)
Study Start Date : February 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


  2. HbA1c [ Time Frame: 12 months ]
    HbA1c was taken at the beginning of the study and after 12 months.


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 12 months ]
  2. Blood Lipids [ Time Frame: 12 months ]
  3. Body Weight [ Time Frame: 12 months ]
  4. Medication Changes [ Time Frame: 12 months ]
    Insulin, Change? -> Yes/No

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



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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580098


Locations
Austria
Klinikum Klagenfurt
Klagenfurt, Carinthia, Austria, 9020
LKH Laas
Kötschach, Carinthia, Austria, 9640
LKH Villach
Villach, Carinthia, Austria, 9500
Sponsors and Collaborators
Landeskrankenanstalten-Betriebsgesellschaft
European Commission

Responsible Party: Landeskrankenanstalten-Betriebsgesellschaft
ClinicalTrials.gov Identifier: NCT01580098     History of Changes
Other Study ID Numbers: D250487
First Posted: April 18, 2012    Key Record Dates
Results First Posted: September 23, 2015
Last Update Posted: September 23, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases