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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014