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RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tuula Karhula, South Karelia, Social and Health Care
ClinicalTrials.gov Identifier:
NCT01310491
First received: March 7, 2011
Last updated: February 14, 2014
Last verified: February 2014
History of Changes
  Purpose
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 Intervention
Type 2 Diabetes
Coronary Artery Disease
Heart Failure
Atrial Fibrillation
Other Arrhythmias
 Behavioral: Health coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH Large-scale Real-life Study in Finland

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by South Karelia, Social and Health Care District:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Health related quality of life is assessed by the SF-36 questionnaire.

  • HbA1c change over time (participants with T2DM only) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood pressure reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Weight reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Activity increase [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Smoke cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Alcohol use reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost for the organization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Satisfaction and usability of the technology and equipments. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Enrollment: 595
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care Behavioral: Health coaching
Telephone based health coaching supported by tele-monitoring.

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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310491

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

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

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 
Study First Received: March 7, 2011
Last Updated: February 14, 2014
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on September 30, 2016