Telemedicine With Metabolic Syndrome

NCT ID: NCT05117580

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-02-28

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.

Conditions

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Metabolic Syndrome Life Style

Keywords

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Telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Active group

The active group get telemedicine devices, and lifestyle interventions.

Group Type EXPERIMENTAL

telemedicine lifestyle guidance

Intervention Type DEVICE

Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.

Comparator Group

The comparator group get the evidence based treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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telemedicine lifestyle guidance

Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.

Intervention Type DEVICE

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):

1. waist width above 102 cm in men and 88 cm in women
2. treated diabetes or blood sugar above 5.6 mmol / l
3. treated hypertension or spontaneous blood pressure ≥ 130/85 mmHg
4. fibrate treatment or triglyceride levels above 1.7 mmol / l
5. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Szeged

Szeged, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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István Kósa, MD, Ph.D.

Role: CONTACT

Phone: +36 70 320 1192

Email: [email protected]

Facility Contacts

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István Kósa, MD, Ph.D.

Role: primary

Other Identifiers

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TMED_METSZI_001

Identifier Type: -

Identifier Source: org_study_id