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Large Scale Demonstrator, Webportal Diabetes (LSD)

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ClinicalTrials.gov Identifier: NCT01570140
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : March 21, 2018
University Medical Center Groningen
Information provided by (Responsible Party):
Henk Bilo, MD, Medical Research Foundation, The Netherlands

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Large Scale Demonstrator, Webportal Diabetes
Actual Study Start Date : May 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: 12 months ]
    EQ-5D questionnaire, representing Health Related Quality of Life dimension

Secondary Outcome Measures :
  1. 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
    • Relaxation
    • Being Active
    • Waking up fresh and rested
    • Being interested in things

  2. Diabetes-related distress [ Time Frame: 12 months ]
    PAID-5, questionnaire for diabetes-related distress

  3. Assessing self-efficacy [ Time Frame: 12 months ]
    SDSCA, assessing self-efficacy

  4. Evaluation of general practice [ Time Frame: 12 months ]
    Europep questionnaire, evaluation of general practice

  5. Clinical parameters [ Time Frame: 12 months ]
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study consists of people known with type 2 diabetes mellitus who are being guided and treated in primary health care in the Drenthe region of the Netherlands.

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

Information from the National Library of Medicine

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

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Isala Clinics
Zwolle, Netherlands
Sponsors and Collaborators
Henk Bilo, MD
University Medical Center Groningen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Henk Bilo, MD, professor, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01570140    
Other Study ID Numbers: LSD
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases