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RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

S

South Karelia, Social and Health Care District

Status

Completed

Conditions

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

Treatments

Behavioral: Health coaching

Study type

Interventional

Funder types

Other

Identifiers

NCT01310491
Renewing Health WP WP 13 Fin

Details and patient eligibility

About

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.

Full 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.

Enrollment

595 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

595 participants in 1 patient group

Usual Care
No Intervention group
Treatment:
Behavioral: Health coaching

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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