RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

RENEWING HEALTH Large-scale Real-life Study in Finland

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Heart Failure; Atrial Fibrillation; Type 2 Diabetes; Other Arrhythmias
• Intervention / Treatment: Behavioral: Health coaching

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 Type: Interventional
• Enrollment (Actual): 595
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Lappeenranta, Finland, 53100
    • Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care	Behavioral: Health coaching; Telephone based health coaching supported by tele-monitoring.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Medication compliance	12 months
Blood pressure reduction	12 months
Weight reduction	12 months
Activity increase	12 months
Smoke cessation	12 months
Alcohol use reduction	12 months
Cost for the organization	12 months
Satisfaction and usability of the technology and equipments.	12 months

Collaborators and Investigators

• Sponsor: South Karelia, Social and Health Care District
• Investigators: Principal Investigator: Tuula Karhula, MD, PhD, South Karelia social and health district

Publications and helpful links

General Publications

• Karhula T, Vuorinen AL, Raapysjarvi K, Pakanen M, Itkonen P, Tepponen M, Junno UM, Jokinen T, van Gils M, Lahteenmaki J, Kohtamaki K, Saranummi N. Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Jun 17;17(6):e153. doi: 10.2196/jmir.4059.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 7, 2011
• First Posted (Estimate): March 8, 2011

Study Record Updates

• Last Update Posted (Estimate): February 17, 2014
• Last Update Submitted That Met QC Criteria: February 14, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Coronary Artery Disease; Atrial Fibrillation
• Other Study ID Numbers: Renewing Health WP WP 13 Fin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No