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

August 21, 2015 updated by: Landeskrankenanstalten-Betriebsgesellschaft

Regions of Europe Working Together for Health (Renewing Health)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Carinthia
      • Klagenfurt, Carinthia, Austria, 9020
        • Klinikum Klagenfurt
      • Kötschach, Carinthia, Austria, 9640
        • LKH Laas
      • Villach, Carinthia, Austria, 9500
        • LKH Villach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
HbA1c
Time Frame: 12 months
HbA1c was taken at the beginning of the study and after 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 12 months
12 months
Blood Lipids
Time Frame: 12 months
12 months
Body Weight
Time Frame: 12 months
12 months
Medication Changes
Time Frame: 12 months
Insulin, Change? -> Yes/No
12 months
Presence of Diabetic Complications
Time Frame: 12 months
12 months
Number of Hospitalisations
Time Frame: 12 months
The number of inpatient stays comparing intervention and control group was conducted.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Landeskrankenanstalten-Betriebsgesellschaft

Collaborators

European Commission

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D250487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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