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Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece (RHCluster2GR)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Telemonitoring of patients with diabetes type 2
Sponsored by
Regional Health Authority of Sterea & Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Telemedicine

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of type 2 Diabetes
  • HbA1c > 53 mmol/mol (7.0 % according to NGSP)
  • Capability to use the devices provided
  • Being cognitively able to participate
  • Capability of filling in questionnaires in german or greek language
  • Absence of severe comorbidity prevalent on diabetes with life expectancy < 12 months

Exclusion Criteria:

  • Pregnancy

Sites / Locations

  • Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Telemonitoring of diabetes 2 patients

Arm Description

Participants in the control group receive usual care. Usual care consists of regular visits to the specialist when required. In the occasion of the visit, HbA1c and glucose measurements are performed and the current oral or insulin therapy is modified if necessary. Patients also receive basic education in the management of diabetes.

Patients will have one educational visit to set up the system and explain how it works. Patients will download their measurements from their tele-glucose meter to their mobile phone and the data will be transferred to the regional database. The care team (a nurse specially trained and the allocated physician) will regularly access the patient's home diary, and will provide the appropriate counselling and medication changes as frequently as necessary. In addition to blood glucose measurements, routine questions about symptoms and eventual difficulties related to diabetes as well as diabetic management will be routinely captured and reported.

Outcomes

Primary Outcome Measures

Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
HbA1c levels
Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)

Secondary Outcome Measures

Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"
Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)
Nutrition habits assessed by validated questionnaire.
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)

Full Information

First Posted
December 21, 2011
Last Updated
February 16, 2015
Sponsor
Regional Health Authority of Sterea & Thessaly
Collaborators
Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT01498367
Brief Title
Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece
Acronym
RHCluster2GR
Official Title
Renewing Health RCT for the Evaluation of Life-long Tele-monitoring of Patients With Diabetes Mellitus Type 2 in Central Greece
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Health Authority of Sterea & Thessaly
Collaborators
Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large tertiary care center.
Detailed Description
The present study aims to examine the clinical and financial effects and the patients' perception and satisfaction of home telemedicine support system for diabetes management versus standard (usual) care. In the intervention group the patients will be provided with a blood glucose meter and a mobile phone and their data will be transferred via the mobile to the regional database and will be assessed by the allocated care team. Appropriate counseling on treatment and symptoms or problems related to diabetes will also be provided. Measurements of HbA1c will be taken to assess glycaemic control while the dietary and the exercise habits will be assessed by the use of questionnaires. In addition the patients' satisfaction from the use of the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will be applied to evaluate the tele-health service compared with the usual care from the health and social perspective. The effect of the tele-health service in the organization structure of the outpatient hospital department will be evaluated with a qualitative study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Telemedicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants in the control group receive usual care. Usual care consists of regular visits to the specialist when required. In the occasion of the visit, HbA1c and glucose measurements are performed and the current oral or insulin therapy is modified if necessary. Patients also receive basic education in the management of diabetes.
Arm Title
Telemonitoring of diabetes 2 patients
Arm Type
Experimental
Arm Description
Patients will have one educational visit to set up the system and explain how it works. Patients will download their measurements from their tele-glucose meter to their mobile phone and the data will be transferred to the regional database. The care team (a nurse specially trained and the allocated physician) will regularly access the patient's home diary, and will provide the appropriate counselling and medication changes as frequently as necessary. In addition to blood glucose measurements, routine questions about symptoms and eventual difficulties related to diabetes as well as diabetic management will be routinely captured and reported.
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring of patients with diabetes type 2
Intervention Description
Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter
Primary Outcome Measure Information:
Title
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
Time Frame
12 months minimum- at the entry point of the intervention and the end.
Title
HbA1c levels
Description
Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)
Time Frame
12 months minimum - at the entry point and every 3 months.
Secondary Outcome Measure Information:
Title
Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"
Time Frame
12 months minimum- at the entry point of the intervention and the end.
Title
Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)
Time Frame
12 months minimum- at the entry point of the intervention and the end.
Title
Nutrition habits assessed by validated questionnaire.
Time Frame
12 months minimum- at the entry point of the intervention and the end.
Title
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time Frame
at 2nd and at 12th month
Title
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)
Time Frame
12 months minimum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of type 2 Diabetes HbA1c > 53 mmol/mol (7.0 % according to NGSP) Capability to use the devices provided Being cognitively able to participate Capability of filling in questionnaires in german or greek language Absence of severe comorbidity prevalent on diabetes with life expectancy < 12 months Exclusion Criteria: Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Koukoulis, MD, PhD
Organizational Affiliation
Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
City
Larisa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
19531058
Citation
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K. Home telehealth for diabetes management: a systematic review and meta-analysis. Diabetes Obes Metab. 2009 Oct;11(10):913-30. doi: 10.1111/j.1463-1326.2009.01057.x. Epub 2009 Jun 16.
Results Reference
background
PubMed Identifier
12716831
Citation
Klonoff DC. Diabetes and telemedicine: is the technology sound, effective, cost-effective, and practical? Diabetes Care. 2003 May;26(5):1626-8. doi: 10.2337/diacare.26.5.1626. No abstract available.
Results Reference
background
PubMed Identifier
17378871
Citation
Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract. 2007 Apr;13(2):242-53. doi: 10.1111/j.1365-2753.2006.00686.x.
Results Reference
background
Links:
URL
http://www.renewinghealth.eu/
Description
"The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community"

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Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece

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