Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece (RHCluster2GR)
This study is ongoing, but not recruiting participants.
Sponsor:
Regional Health Authority of Sterea & Thessaly
Collaborators:
Ministry of Health and Social Welfare, Greece
Municipality of Trikala, Greece
e-trikala SA, Trikala, Greece
Cities Net SA, Trikala, Greece
Biomedical Research & Technology (BIOMED, Larissa, Greece
Institute of Communications and Computer Systems (ICCS), Athens, Greece
Technological Educational Institute of Thessaloniki, Greece
University of Macedonia, Thessaloniki, Greece
University of Thessaly
Information provided by (Responsible Party):
Georgios Koukoulis, Regional Health Authority of Sterea & Thessaly
ClinicalTrials.gov Identifier:
NCT01498367
First received: December 21, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 Telemedicine |
Procedure: Telemonitoring of patients with diabetes type 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Renewing Health RCT for the Evaluation of Life-long Tele-monitoring of Patients With Diabetes Mellitus Type 2 in Central Greece |
Resource links provided by NLM:
Further study details as provided by Regional Health Authority of Sterea & Thessaly:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- HbA1c levels [ Time Frame: 12 months minimum - at the entry point and every 3 months. ] [ Designated as safety issue: No ]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" [ Time Frame: 12 months minimum- at the entry point of the intervention and the end. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Nutrition habits assessed by validated questionnaire. [ Time Frame: 12 months minimum- at the entry point of the intervention and the end. ] [ Designated as safety issue: No ]
- Patients' Acceptance-Satisfaction measured by the WSD Questionnaire [ Time Frame: at 2nd and at 12th month ] [ Designated as safety issue: No ]
- Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis) [ Time Frame: 12 months minimum ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Usual care
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.
|
|
|
Experimental: Telemonitoring of diabetes 2 patients
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.
|
Procedure: Telemonitoring of patients with diabetes type 2
Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498367
Locations
| Greece | |
| Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa | |
| Larisa, Thessaly, Greece, 41110 | |
Sponsors and Collaborators
Regional Health Authority of Sterea & Thessaly
Ministry of Health and Social Welfare, Greece
Municipality of Trikala, Greece
e-trikala SA, Trikala, Greece
Cities Net SA, Trikala, Greece
Biomedical Research & Technology (BIOMED, Larissa, Greece
Institute of Communications and Computer Systems (ICCS), Athens, Greece
Technological Educational Institute of Thessaloniki, Greece
University of Macedonia, Thessaloniki, Greece
University of Thessaly
Investigators
| Principal Investigator: | Georgios Koukoulis, MD, PhD | Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa |
More Information
Additional Information:
Publications:
| Responsible Party: | Georgios Koukoulis, Associate Proffesor, Director of the Endocrinology and Metabolic Diseases Department, University Hospital of Larissa, Regional Health Authority of Sterea & Thessaly |
| ClinicalTrials.gov Identifier: | NCT01498367 History of Changes |
| Other Study ID Numbers: | FR2015, EC Grant Agreement 250487 |
| Study First Received: | December 21, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Regional Health Authority of Sterea & Thessaly:
|
Diabetes Mellitus, Type 2 Telemedicine |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013