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RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

Primary Purpose

Type 2 Diabetes, Coronary Artery Disease, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Health coaching
Sponsored by
South Karelia, Social and Health Care District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Medication compliance
Blood pressure reduction
Weight reduction
Activity increase
Smoke cessation
Alcohol use reduction
Cost for the organization
Satisfaction and usability of the technology and equipments.

Full Information

First Posted
March 7, 2011
Last Updated
February 14, 2014
Sponsor
South Karelia, Social and Health Care District
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1. Study Identification

Unique Protocol Identification Number
NCT01310491
Brief Title
RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH
Official Title
RENEWING HEALTH Large-scale Real-life Study in Finland
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Karelia, Social and Health Care District

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Coronary Artery Disease, Heart Failure, Atrial Fibrillation, Other Arrhythmias

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
595 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
Telephone based health coaching supported by tele-monitoring.
Primary Outcome Measure Information:
Title
Health related quality of life
Description
Health related quality of life is assessed by the SF-36 questionnaire.
Time Frame
12 months
Title
HbA1c change over time (participants with T2DM only)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Medication compliance
Time Frame
12 months
Title
Blood pressure reduction
Time Frame
12 months
Title
Weight reduction
Time Frame
12 months
Title
Activity increase
Time Frame
12 months
Title
Smoke cessation
Time Frame
12 months
Title
Alcohol use reduction
Time Frame
12 months
Title
Cost for the organization
Time Frame
12 months
Title
Satisfaction and usability of the technology and equipments.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuula Karhula, MD, PhD
Organizational Affiliation
South Karelia social and health district
Official's Role
Principal Investigator
Facility Information:
Facility Name
Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä
City
Lappeenranta
ZIP/Postal Code
53100
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26084979
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.
Results Reference
derived

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RENEWING HEALTH - RegioNs of Europe WorkINg Together for HEALTH

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