NCT01580098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 23, 2015

Completed
Last Updated

September 23, 2015

Status Verified

April 1, 2015

Enrollment Period

3.5 years

First QC Date

April 17, 2012

Results QC Date

April 8, 2015

Last Update Submit

August 21, 2015

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 months

  • HbA1c

    HbA1c was taken at the beginning of the study and after 12 months.

    12 months

Secondary Outcomes (6)

  • Blood Pressure

    12 months

  • Blood Lipids

    12 months

  • Body Weight

    12 months

  • Medication Changes

    12 months

  • Presence of Diabetic Complications

    12 months

  • +1 more secondary outcomes

Study Arms (3)

Control group

NO INTERVENTION

treatment as usual

Self-monitoring for patients with Diabetes mellitus type 2

EXPERIMENTAL

Patients are self-monitoring and submitting their vital parameters.

Other: Self-monitoring for patients with Diabetes mellitus type 2

Nurse-monitoring for patients with Diabetes mellitus type 2

EXPERIMENTAL

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

Other: Nurse-monitoring for patients with Diabetes mellitus type 2

Interventions

Self-monitoring for patients with Diabetes mellitus type 2OTHER

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

Self-monitoring for patients with Diabetes mellitus type 2
Nurse-monitoring for patients with Diabetes mellitus type 2OTHER

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

Nurse-monitoring for patients with Diabetes mellitus type 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Klagenfurt

Klagenfurt, Carinthia, 9020, Austria

Location

LKH Laas

Kötschach, Carinthia, 9640, Austria

Location

LKH Villach

Villach, Carinthia, 9500, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Hannes Steinberger
Organization
Landeskrankenanstalten-Betriebsgesellschaft
hannes.steinberger@kabeg.at
+4346355212 50303

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 18, 2012

Study Start

February 1, 2010

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

September 23, 2015

Results First Posted

September 23, 2015

Record last verified: 2015-04

Locations

AU(3)