Clinical trial NCT01310491: RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH
Official title: RENEWING HEALTH Large-scale Real-life Study in Finland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Coronary Artery Disease
Heart Failure
Atrial Fibrillation
Other Arrhythmias
Lead sponsor: South Karelia, Social and Health Care District
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Primary outcomes:
measure: Health related quality of life
timeFrame: 12 months
measure: HbA1c change over time (participants with T2DM only)
timeFrame: 12 months
Secondary outcomes:
measure: Medication compliance
timeFrame: 12 months
measure: Blood pressure reduction
timeFrame: 12 months
measure: Weight reduction
timeFrame: 12 months
measure: Activity increase
timeFrame: 12 months
measure: Smoke cessation
timeFrame: 12 months
measure: Alcohol use reduction
timeFrame: 12 months
measure: Cost for the organization
timeFrame: 12 months
measure: Satisfaction and usability of the technology and equipments.
timeFrame: 12 months
Other outcomes:
Locations:
city: Lappeenranta
country: Finland
facility: Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä
Study officials:
affiliation: South Karelia social and health district
name: Tuula Karhula, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karhula T, Vuorinen AL, Raapysjarvi K, Pakanen M, Itkonen P, Tepponen M, Junno UM, Jokinen T, van Gils M, Lahteenmaki J, Kohtamaki K, Saranummi N. Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Jun 17;17(6):e153. doi: 10.2196/jmir.4059.