RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH
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ClinicalTrials.gov Identifier: NCT01310491 |
Recruitment Status
:
Completed
First Posted
: March 8, 2011
Last Update Posted
: February 17, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Coronary Artery Disease Heart Failure Atrial Fibrillation Other Arrhythmias | Behavioral: Health coaching | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 595 participants |
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 |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
No Intervention: Usual Care |
Behavioral: Health coaching
Telephone based health coaching supported by tele-monitoring.
|
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310491
Finland | |
Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä | |
Lappeenranta, Finland, 53100 |
Principal Investigator: | Tuula Karhula, MD, PhD | South Karelia social and health district |
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 |
First Posted: | March 8, 2011 Key Record Dates |
Last Update Posted: | February 17, 2014 |
Last Verified: | February 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 |