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OpenTrials
Completed

NCT Number: NCT01580098

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Klagenfurt, Klagenfurt, Carinthia, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-monitoring for patients with Diabetes mellitus type 2

Other

Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.

Nurse-monitoring for patients with Diabetes mellitus type 2

Other

Nurses are submitting the vital parameters of the patient via mobile device.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Landeskrankenanstalten-Betriebsgesellschaft

Industry

Collaborators

  • European Commission

Registry information

Official study title

Regions of Europe Working Together for Health (Renewing Health)

Acronym: RenewingHealth

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Apr 18, 2012
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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