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

March 7, 2011
February 14, 2014
February 2011
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01310491 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Costh 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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Type 2 Diabetes
  • Coronary Artery Disease
  • Heart Failure
  • Atrial Fibrillation
  • Other Arrhythmias
Behavioral: Health coaching
Telephone based health coaching supported by tele-monitoring.
No Intervention: Usual Care
Intervention: Behavioral: Health coaching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
595
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01310491
Renewing Health WP WP 13 Fin
No
Tuula Karhula, South Karelia, Social and Health Care
South Karelia, Social and Health Care
Not Provided
Principal Investigator: Tuula Karhula, MD, PhD South Karelia social and health district
South Karelia, Social and Health Care
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP