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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Self-monitoring for patients with Diabetes mellitus type 2
Nurse-monitoring for patients with Diabetes mellitus type 2
Sponsored by
Landeskrankenanstalten-Betriebsgesellschaft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Klinikum Klagenfurt
  • LKH Laas
  • LKH Villach

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Self-monitoring for patients with Diabetes mellitus type 2

Nurse-monitoring for patients with Diabetes mellitus type 2

Arm Description

treatment as usual

Patients are self-monitoring and submitting their vital parameters.

Nurses are measuring and entering the vital parameters of the patients.

Outcomes

Primary Outcome Measures

Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
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.
HbA1c
HbA1c was taken at the beginning of the study and after 12 months.

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2012
Last Updated
August 21, 2015
Sponsor
Landeskrankenanstalten-Betriebsgesellschaft
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01580098
Brief Title
Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus
Acronym
RenewingHealth
Official Title
Regions of Europe Working Together for Health (Renewing Health)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landeskrankenanstalten-Betriebsgesellschaft
Collaborators
European Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
treatment as usual
Arm Title
Self-monitoring for patients with Diabetes mellitus type 2
Arm Type
Experimental
Arm Description
Patients are self-monitoring and submitting their vital parameters.
Arm Title
Nurse-monitoring for patients with Diabetes mellitus type 2
Arm Type
Experimental
Arm Description
Nurses are measuring and entering the vital parameters of the patients.
Intervention Type
Other
Intervention Name(s)
Self-monitoring for patients with Diabetes mellitus type 2
Intervention Description
Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Intervention Type
Other
Intervention Name(s)
Nurse-monitoring for patients with Diabetes mellitus type 2
Intervention Description
Nurses are submitting the vital parameters of the patient via mobile device.
Primary Outcome Measure Information:
Title
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Description
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.
Time Frame
12 months
Title
HbA1c
Description
HbA1c was taken at the beginning of the study and after 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
12 months
Title
Blood Lipids
Time Frame
12 months
Title
Body Weight
Time Frame
12 months
Title
Medication Changes
Description
Insulin, Change? -> Yes/No
Time Frame
12 months
Title
Presence of Diabetic Complications
Time Frame
12 months
Title
Number of Hospitalisations
Description
The number of inpatient stays comparing intervention and control group was conducted.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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:
Facility Information:
Facility Name
Klinikum Klagenfurt
City
Klagenfurt
State/Province
Carinthia
ZIP/Postal Code
9020
Country
Austria
Facility Name
LKH Laas
City
Kötschach
State/Province
Carinthia
ZIP/Postal Code
9640
Country
Austria
Facility Name
LKH Villach
City
Villach
State/Province
Carinthia
ZIP/Postal Code
9500
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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