RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

Study Overview
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Brief Summary
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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
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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.

Official Title
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RENEWING HEALTH Large-scale Real-life Study in Finland

Conditions
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Type 2 Diabetes, Coronary Artery Disease, Heart Failure, Atrial Fibrillation, Other Arrhythmias

Intervention / Treatment
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* Behavioral: Health coaching


Participation Criteria
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Eligibility Criteria
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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 Heart Failure or Atrial fibrillation or Other arrhythmia Be able to walk Exclusion Criteria: Not willing to participate (e.g., not willing to sign the consent)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | Behavioral: Health coaching<br>* Telephone based health coaching supported by tele-monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Health related quality of life is assessed by the SF-36 questionnaire. | 12 months | 
| HbA1c change over time (participants with T2DM only) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication compliance |  | 12 months | 
| Blood pressure reduction |  | 12 months | 
| Weight reduction |  | 12 months | 
| Activity increase |  | 12 months | 
| Smoke cessation |  | 12 months | 
| Alcohol use reduction |  | 12 months | 
| Cost for the organization |  | 12 months | 
| Satisfaction and usability of the technology and equipments. |  | 12 months |