Telemedicine With Metabolic Syndrome

Study Overview
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Brief Summary
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Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.

Detailed Description
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The patients are using mobile phone-based nutrition diary with heart rate monitoring watch (including activity meter) connected to a mobile phone with bluetooth technology worn on a wrist. These devices, and the weight scale, blood pressure monitor are connected with bluetooth to an IT system, that transmits and displays data from these devices. the patients are using the devices during 3 months, and get instructions about lifestyle.

Official Title
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Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions

Conditions
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Metabolic Syndrome, Life Style

Intervention / Treatment
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* Device: telemedicine lifestyle guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 years and 75 years Presence of at least three of the following five risk factors (Metabolic Syndrome ATP III Criteria): waist width above 102 cm in men and 88 cm in women treated diabetes or blood sugar above 5.6 mmol / l treated hypertension or spontaneous blood pressure ≥ 130/85 mmHg fibrate treatment or triglyceride levels above 1.7 mmol / l blood HDL cholesterol levels below 1.03 mmol / l in men and 1.3 mmol / l in women Exclusion Criteria: Low level of physical activity (less than 30 minutes a day) IT proficiency at least for basic use of mobile phones (answering / making voice calls). For women with childbearing potential, by definition, all women who are able to conceive physiologically use dual contraception Signing an informed consent. The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>The active group get telemedicine devices, and lifestyle interventions. | Device: telemedicine lifestyle guidance<br>* Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.<br>|
| No Intervention: Comparator Group<br>The comparator group get the evidence based treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of abdominal circumference | To investigate the effect of telemedicine-assisted lifestyle intervention on anthropometric parameters, with particular reference to the reduction of abdominal circumference in patients with metabolic syndrome. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4. | The safety of the device system | 3 months | 
| Impact of the system to the cardiovascular risk | In patients with metabolic syndrome, high cardiovascular risk, the impact of complex lifestyle interventions initiated in different environments and then telemedicine, including lifestyle and physical activity, on the known cardiovascular risk factors and functional indicators | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine