Clinical trial NCT01498367: Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Telemedicine
Lead sponsor: Regional Health Authority of Sterea & Thessaly
Sponsor class: OTHER_GOV
Collaborators: name: Ministry for Health and Social Solidarity, Greece
name: Municipality of Trikala, Greece
name: e-Trikala S.A.
name: Cities Net SA
name: Institute of Biomedical Research & Technology, Larissa, Greece
name: Institute of Communications and Computer Systems, Athens, Greece
name: Alexander Technological Educational Institute, Thessaloniki, Greece
name: University of Macedonia, Thessaloniki, Greece
name: University of Thessaly
First posted: 2011-12-23
Enrollment: 154
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: 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.

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

Primary outcomes:
measure: Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
timeFrame: 12 months minimum- at the entry point of the intervention and the end.
measure: HbA1c levels
timeFrame: 12 months minimum - at the entry point and every 3 months.
Secondary outcomes:
measure: Emotional functioning in diabetes assessed by the "Problem areas in diabetes questionnaire - PAID © 1999 Joslin Diabetes Center"
timeFrame: 12 months minimum- at the entry point of the intervention and the end.
measure: Physical activity measured by the "International Physical Activity Questionnaire" (IPAQ)
timeFrame: 12 months minimum- at the entry point of the intervention and the end.
measure: Nutrition habits assessed by validated questionnaire.
timeFrame: 12 months minimum- at the entry point of the intervention and the end.
measure: Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
timeFrame: at 2nd and at 12th month
measure: Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)
timeFrame: 12 months minimum
Other outcomes:
Locations:
city: Larisa
country: Greece
facility: Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
state: Thessaly
Study officials:
affiliation: Endocrinology and Metabolic Diseases Department - Regional University Hospital of Larisa
name: Georgios Koukoulis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.