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

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Other: Self-monitoring for patients with Diabetes mellitus type 2; Other: Nurse-monitoring for patients with Diabetes mellitus type 2

• Registration Number: NCT01580098
• Lead Sponsor: Landeskrankenanstalten-Betriebsgesellschaft

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Primary Completion: 2013-08
• Study Completion: 2014-02
• Status Verified: 2015-04
• Results First Submitted: 2015-04-08
• Results First Submitted QC: 2015-08-21
• Last Update Submitted: 2015-08-21
• Results First Posted: 2015-09-23
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-monitoring for patients with Diabetes mellitus type 2	Self-monitoring for patients with Diabetes mellitus type 2	Patients are self-monitoring and submitting their vital parameters.
Nurse-monitoring for patients with Diabetes mellitus type 2	Nurse-monitoring for patients with Diabetes mellitus type 2	Nurses are measuring and entering the vital parameters of the patients.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	12 months
Blood Lipids	12 months
Body Weight	12 months
Medication Changes	12 months	Insulin, Change? -\> Yes/No
Presence of Diabetic Complications	12 months
Number of Hospitalisations	12 months	The number of inpatient stays comparing intervention and control group was conducted.

Trial Locations

Locations (3)

LKH Villach; 🇦🇹 Villach, Carinthia, Austria

Klinikum Klagenfurt; 🇦🇹 Klagenfurt, Carinthia, Austria

LKH Laas; 🇦🇹 Kötschach, Carinthia, Austria