RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Heart Failure; Atrial Fibrillation; Other Arrhythmias; Type 2 Diabetes
• Interventions: Behavioral: Health coaching

• Registration Number: NCT01310491
• Lead Sponsor: South Karelia, Social and Health Care District

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-14
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 595

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Health coaching	-

Primary Outcome Measures

Name	Time	Method
Health related quality of life	12 months	Health related quality of life is assessed by the SF-36 questionnaire.
HbA1c change over time (participants with T2DM only)	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä; 🇫🇮 Lappeenranta, Finland