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RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH
This study has been completed.
Sponsor:
South Karelia, Social and Health Care District
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
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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: None (Open Label) Primary Purpose: Supportive Care |
| Official Title: | RENEWING HEALTH Large-scale Real-life Study in Finland |
Resource links provided by NLM:
Further study details as provided by Tuula Karhula, South Karelia, Social and Health Care:
Primary Outcome Measures:
- Health related quality of life [ Time Frame: 12 months ]Health related quality of life is assessed by the SF-36 questionnaire.
- HbA1c change over time (participants with T2DM only) [ Time Frame: 12 months ]
Secondary Outcome Measures:
- Medication compliance [ Time Frame: 12 months ]
- Blood pressure reduction [ Time Frame: 12 months ]
- Weight reduction [ Time Frame: 12 months ]
- Activity increase [ Time Frame: 12 months ]
- Smoke cessation [ Time Frame: 12 months ]
- Alcohol use reduction [ Time Frame: 12 months ]
- Cost for the organization [ Time Frame: 12 months ]
- Satisfaction and usability of the technology and equipments. [ Time Frame: 12 months ]
| 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) |
| 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
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
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 |
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 August 18, 2017