Large Scale Demonstrator, Webportal Diabetes (LSD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01570140|
Recruitment Status : Unknown
Verified November 2013 by Nanne Kleefstra, Medical Research Foundation, The Netherlands.
Recruitment status was: Recruiting
First Posted : April 4, 2012
Last Update Posted : December 2, 2013
Rationale: Accounting for the growth, aging and detrimental life style changes in the Dutch population, the investigators expect further growth of number of known diabetes patients. The economic burden with this increase will be enormous, the healthcare system is under increasing pressure to provide better but more time efficient service to more people with limited human resources. the investigators hypothesize that, by increasing the patients self-management by offering remote care services, this reduction of the individual caseload can be achieved.
Objective: Primary objective is to test the hypothesis that the consistent use of a web portal and its educational content and the possibility to review personal diabetes related data for type 2 diabetes patients (T2DM) in the primary care setting, will result in an improvement quality of life.
Study design and methods: In this Prospective observational cohort study the investigators examine the effect of the voluntarily use of a web portal and its educational content. The primary end point is health related quality of life. We predefined a clinically relevant difference of 0.074 in the EQ-5D index score. Secondary endpoints are diabetes-related distress and well being and a selection of clinical measurements, number of contacts with health care provider and the amount of prescribed medication. The participants are being followed for 1-year and the data will be collected at baseline, after 6 months and 12 months.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus Type 2||Behavioral: Web portal|
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Large Scale Demonstrator, Webportal Diabetes|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||October 2015|
Web portal users
T2DM patients in the primary care setting, using the web portal.
Behavioral: Web portal
This study investigates the effects of the voluntarily use of a webportal and its educational content.
- Health Related Quality of Life [ Time Frame: 12 months ]EQ-5D questionnaire, representing Health Related Quality of Life dimension
- Well-being Index: WHO-5 questionnaire [ Time Frame: 12 months ]
This five items questionnaire covers positive mood, vitality and general interests. The WHO-5 measures not only the absence of symptoms but gives a reliable indication of mental well-being.This includes the following dimensions:
- Good spirits
- Being Active
- Waking up fresh and rested
- Being interested in things
- Diabetes-related distress [ Time Frame: 12 months ]PAID-5, questionnaire for diabetes-related distress
- Assessing self-efficacy [ Time Frame: 12 months ]SDSCA, assessing self-efficacy
- Evaluation of general practice [ Time Frame: 12 months ]Europep questionnaire, evaluation of general practice
- Clinical parameters [ Time Frame: 12 months ]
- Quetelet index (BMI)
- Systolic/diastolic blood pressure
- Lipid profile fasting
- Albumin/Creatinine ratio
- monofilament test feet
- SIMMS classification
- Fundus photo assessment
- Use of alcohol
- FiveShot questionnaire
- Diabetes medicine
- Additional medication
- Cardiovascular complications
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): NCT01570140
|Contact: N Kleefstra, MD, PhD||0031-38-4244013|
|Contact: N Kleefstra, MD, PhD 0031-38-4244013|