Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece (RHCluster2GR)
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|ClinicalTrials.gov Identifier: NCT01498367|
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Procedure: Telemonitoring of patients with diabetes type 2||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
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
- 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. ]
- HbA1c levels [ Time Frame: 12 months minimum - at the entry point and every 3 months. ]Glycated hemoglobin (HbA1c) levels at the entry point and every 3 months (for a period of 12 months minimum)
- 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. ]
- 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. ]
- Nutrition habits assessed by validated questionnaire. [ Time Frame: 12 months minimum- at the entry point of the intervention and the end. ]
- Patients' Acceptance-Satisfaction measured by the WSD Questionnaire [ Time Frame: at 2nd and at 12th month ]
- Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis) [ Time Frame: 12 months minimum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498367
|Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa|
|Larisa, Thessaly, Greece, 41110|
|Principal Investigator:||Georgios Koukoulis, MD, PhD||Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa|