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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Landeskrankenanstalten-Betriebsgesellschaft
ClinicalTrials.gov Identifier:
NCT01580098
First received: April 17, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Landeskrankenanstalten-Betriebsgesellschaft:

Primary Outcome Measures:
  • Health related quality of life as measured by the SF 36 version 2 questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood lipids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Medication changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Insulin, Change? -> Yes/No

  • Presence of diabetic complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of hospitalisations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: February 2010
Estimated Primary Completion Date: June 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.

  Eligibility

Genders Eligible for Study:   Both
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Landeskrankenanstalten-Betriebsgesellschaft
ClinicalTrials.gov Identifier: NCT01580098     History of Changes
Other Study ID Numbers: D250487
Study First Received: April 17, 2012
Last Updated: August 14, 2012
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on May 16, 2013