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RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

RENEWING HEALTH Large-scale Real-life Study in Finland

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01310491
Enrollment
595
Registered
2011-03-08
Start date
2011-02-28
Completion date
2012-12-31
Last updated
2014-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Coronary Artery Disease, Heart Failure, Other Arrhythmias, Type 2 Diabetes

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.

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.

Interventions

BEHAVIORALHealth coaching

Telephone based health coaching supported by tele-monitoring.

Sponsors

South Karelia, Social and Health Care District
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Health related quality of life12 monthsHealth related quality of life is assessed by the SF-36 questionnaire.
HbA1c change over time (participants with T2DM only)12 months

Secondary

MeasureTime frame
Weight reduction12 months
Activity increase12 months
Smoke cessation12 months
Medication compliance12 months
Cost for the organization12 months
Satisfaction and usability of the technology and equipments.12 months
Alcohol use reduction12 months
Blood pressure reduction12 months

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026