Large Scale Demonstrator, Webportal Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Large Scale Demonstrator, Webportal Diabetes

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Behavioral: Web portal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of type 2 diabetes mellitus, as registered in the primary care system under the diagnosis T90.2, and where the GP is defined as the main care giver Aged 18 years or older Exclusion Criteria: Cohort study: None Intervention study: Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past Insufficient knowledge of the Dutch language to understand the requirements of the study and/or the questions posed in the questionnaires Life expectancy < 1 year due to malignancies or other terminal illnesses Cognitive impairment, including dementia, that interferes with trial participation Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Web portal users<br>T2DM patients in the primary care setting, using the web portal. | Behavioral: Web portal<br>* This study investigates the effects of the voluntarily use of a webportal and its educational content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | EQ-5D questionnaire, representing Health Related Quality of Life dimension | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being Index: WHO-5 questionnaire | 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 Relaxation Being Active Waking up fresh and rested Being interested in things | 12 months | 
| Diabetes-related distress | PAID-5, questionnaire for diabetes-related distress | 12 months | 
| Assessing self-efficacy | SDSCA, assessing self-efficacy | 12 months | 
| Evaluation of general practice | Europep questionnaire, evaluation of general practice | 12 months | 
| Clinical parameters | Quetelet index (BMI) Systolic/diastolic blood pressure Creatinine Lipid profile fasting Albumin/Creatinine ratio MDRD monofilament test feet SIMMS classification Fundus photo assessment Smoking Use of alcohol FiveShot questionnaire Diabetes medicine Antihypertensiva Antilipaemica Additional medication Cardiovascular complications | 12 months |