RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes; Coronary Artery Disease; Heart Failure; Atrial Fibrillation; Other Arrhythmias	Behavioral: Health coaching	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	595 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	RENEWING HEALTH Large-scale Real-life Study in Finland
Study Start Date :	February 2011
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Health related quality of life [ Time Frame: 12 months ]
   Health related quality of life is assessed by the SF-36 questionnaire.
2. HbA1c change over time (participants with T2DM only) [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Medication compliance [ Time Frame: 12 months ]
2. Blood pressure reduction [ Time Frame: 12 months ]
3. Weight reduction [ Time Frame: 12 months ]
4. Activity increase [ Time Frame: 12 months ]
5. Smoke cessation [ Time Frame: 12 months ]
6. Alcohol use reduction [ Time Frame: 12 months ]
7. Cost for the organization [ Time Frame: 12 months ]
8. Satisfaction and usability of the technology and equipments. [ Time Frame: 12 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

South Karelia, Social and Health Care District

Investigators

Principal Investigator:	Tuula Karhula, MD, PhD	South Karelia social and health district

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Karhula T, Vuorinen AL, Rääpysjärvi K, Pakanen M, Itkonen P, Tepponen M, Junno UM, Jokinen T, van Gils M, Lähteenmäki J, Kohtamäki 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.

Responsible Party:	Tuula Karhula, Substitute Director of Elderly Services, South Karelia, Social and Health Care
ClinicalTrials.gov Identifier:	NCT01310491 History of Changes
Other Study ID Numbers:	Renewing Health WP WP 13 Fin
First Posted:	March 8, 2011
Last Update Posted:	February 17, 2014
Last Verified:	February 2014

Additional relevant MeSH terms:

Heart Failure; Atrial Fibrillation; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases