RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH
The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.
Type 2 Diabetes
Coronary Artery Disease
Behavioral: Health coaching
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||RENEWING HEALTH Large-scale Real-life Study in Finland|
- Health related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]Health related quality of life is assessed by the SF-36 questionnaire.
- HbA1c change over time (participants with T2DM only) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Medication compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Blood pressure reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Weight reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Activity increase [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Smoke cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Alcohol use reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Cost for the organization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Satisfaction and usability of the technology and equipments. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|No Intervention: Usual Care||
Behavioral: Health coaching
Telephone based health coaching supported by tele-monitoring.
RENEWING HEALTH is a project covering 9 different European States. It aims at evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology. In 9 European regions in the implementation of health-related information and communication technologies service solutions are already operational at local level for the remote monitoring and the treatment of chronic patients suffering from diabetes,chronic obstructive pulmonary disease or cardiovascular diseases. The services are designed to give patients a central role in the management of their own diseases, fine-tuning the choice and dosage of medications, promoting compliance to treatment, and helping health care professionals to detect early signs of worsening in the monitored pathologies. Every area will designed its own real-life trial with certain common elements.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310491
|Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä|
|Lappeenranta, Finland, 53100|
|Principal Investigator:||Tuula Karhula, MD, PhD||South Karelia social and health district|