RENEWING HEALTH Large-scale Real-life Study in Finland
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- South Karelia, Social and Health Care District
- Enrollment
- 595
- Locations
- 1
- Primary Endpoint
- Health related quality of life
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tuula Karhula
Substitute Director of Elderly Services
South Karelia, Social and Health Care District
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years
- •Capability of filling in questionnaires in Finnish language.
- •Be able to use Remote Patient Monitoring System
- •Be able to use the devices provided
- •Has adequate cognitive capacities to participate
- •In their medical records, one or both of the following diagnoses:
- •a) Type 2 Diabetes, for enrolment
- •diagnosed over 3 months prior to the enrolment and
- •HbA1c \> 6,5 % b) Heart Disease, for enrolment
- •Ischemic heart disease or
Exclusion Criteria
- •Not willing to participate (e.g., not willing to sign the consent)
Outcomes
Primary Outcomes
Health related quality of life
Time Frame: 12 months
Health related quality of life is assessed by the SF-36 questionnaire.
HbA1c change over time (participants with T2DM only)
Time Frame: 12 months
Secondary Outcomes
- Weight reduction(12 months)
- Activity increase(12 months)
- Alcohol use reduction(12 months)
- Medication compliance(12 months)
- Blood pressure reduction(12 months)
- Smoke cessation(12 months)
- Cost for the organization(12 months)
- Satisfaction and usability of the technology and equipments.(12 months)