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OpenTrials
Completed

NCT Number: NCT01310491

RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Health Coaching

Behavioral

Telephone based health coaching supported by tele-monitoring.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

South Karelia, Social and Health Care District

Other

Registry information

Official study title

RENEWING HEALTH Large-scale Real-life Study in Finland

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2011
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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