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

Diabetes Mellitus Type 2 Clinical Trial

— RenewingHealth  

Official title:

Regions of Europe Working Together for Health (Renewing Health)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580098
• Other study ID #: D250487
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: August 21, 2015
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Landeskrankenanstalten-Betriebsgesellschaft
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: February 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

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.
• Nurse-monitoring for patients with Diabetes mellitus type 2
Nurses are submitting the vital parameters of the patient via mobile device.

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt	Klagenfurt	Carinthia
Austria	LKH Laas	Kötschach	Carinthia
Austria	LKH Villach	Villach	Carinthia

Sponsors (2)

Lead Sponsor	Collaborator
Landeskrankenanstalten-Betriebsgesellschaft	European Commission

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	HbA1c	HbA1c was taken at the beginning of the study and after 12 months.	12 months	No
Secondary	Blood Pressure		12 months	No
Secondary	Blood Lipids		12 months	No
Secondary	Body Weight		12 months	No
Secondary	Medication Changes	Insulin, Change? -> Yes/No	12 months	No
Secondary	Presence of Diabetic Complications		12 months	No
Secondary	Number of Hospitalisations	The number of inpatient stays comparing intervention and control group was conducted.	12 months	No