RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

NCT ID: NCT01310491

Last Updated: 2014-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 595 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

Group Type: NO_INTERVENTION

Health coaching

Intervention Type: BEHAVIORAL

Telephone based health coaching supported by tele-monitoring.

Interventions

Health coaching

Telephone based health coaching supported by tele-monitoring.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Karelia, Social and Health Care District

OTHER

Sponsor Role: lead

Responsible Party

Tuula Karhula

Substitute Director of Elderly Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuula Karhula, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

South Karelia social and health district

Locations

Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä

Lappeenranta, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 26084979 (View on PubMed)

Other Identifiers

Renewing Health WP WP 13 Fin

Identifier Type: -

Identifier Source: org_study_id