RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

Coronary Artery Disease Clinical Trial

Official title:

RENEWING HEALTH Large-scale Real-life Study in Finland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310491
• Other study ID #: Renewing Health WP WP 13 Fin
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: February 14, 2014
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: South Karelia, Social and Health Care District
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Health coaching
Telephone based health coaching supported by tele-monitoring.

Locations

Country	Name	City	State
Finland	Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä	Lappeenranta

Sponsors (1)

Lead Sponsor	Collaborator
South Karelia, Social and Health Care District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life	Health related quality of life is assessed by the SF-36 questionnaire.	12 months	No
Primary	HbA1c change over time (participants with T2DM only)		12 months	No
Secondary	Medication compliance		12 months	No
Secondary	Blood pressure reduction		12 months	No
Secondary	Weight reduction		12 months	No
Secondary	Activity increase		12 months	No
Secondary	Smoke cessation		12 months	No
Secondary	Alcohol use reduction		12 months	No
Secondary	Cost for the organization		12 months	No
Secondary	Satisfaction and usability of the technology and equipments.		12 months	No