Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus (RenewingHealth)
|ClinicalTrials.gov Identifier: NCT01580098|
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : September 23, 2015
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2||Other: Self-monitoring for patients with Diabetes mellitus type 2 Other: Nurse-monitoring for patients with Diabetes mellitus type 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Regions of Europe Working Together for Health (Renewing Health)|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||February 2014|
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.
- Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire [ Time Frame: 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 [ Time Frame: 12 months ]HbA1c was taken at the beginning of the study and after 12 months.
- Blood Pressure [ Time Frame: 12 months ]
- Blood Lipids [ Time Frame: 12 months ]
- Body Weight [ Time Frame: 12 months ]
- Medication Changes [ Time Frame: 12 months ]Insulin, Change? -> Yes/No
- Presence of Diabetic Complications [ Time Frame: 12 months ]
- Number of Hospitalisations [ Time Frame: 12 months ]The number of inpatient stays comparing intervention and control group was conducted.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580098
|Klagenfurt, Carinthia, Austria, 9020|
|Kötschach, Carinthia, Austria, 9640|
|Villach, Carinthia, Austria, 9500|