RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH
| Tracking Information | |||||
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| First Received Date ICMJE | March 7, 2011 | ||||
| Last Updated Date | February 6, 2013 | ||||
| Start Date ICMJE | February 2011 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01310491 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH | ||||
| Official Title ICMJE | RENEWING HEALTH Large-scale Real-life Study in Finland | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Health coaching
Telephone based health coaching supported by tele-monitoring. |
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| Study Arm (s) | No Intervention: Usual Care
Intervention: Behavioral: Health coaching |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 595 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01310491 | ||||
| Other Study ID Numbers ICMJE | Renewing Health WP WP 13 Fin | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tuula Karhula, South Karelia, Social and Health Care | ||||
| Study Sponsor ICMJE | South Karelia, Social and Health Care | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | South Karelia, Social and Health Care | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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