Large Scale Demonstrator, Webportal Diabetes (LSD)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Large Scale Demonstrator, Webportal Diabetes|
- Health Related Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]EQ-5D questionnaire, representing Health Related Quality of Life dimension
- Well-being Index: WHO-5 questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]PAID-5, questionnaire for diabetes-related distress
- Assessing self-efficacy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]SDSCA, assessing self-efficacy
- Evaluation of general practice [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Europep questionnaire, evaluation of general practice
- Clinical parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570140
|Contact: N Kleefstra, MD, PhD||0031-38-4244013|
|Contact: N Kleefstra, MD, PhD 0031-38-4244013|