This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Large Scale Demonstrator, Webportal Diabetes (LSD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Nanne Kleefstra, Medical Research Foundation, The Netherlands.
Recruitment status was:  Recruiting
University Medical Center Groningen
Information provided by (Responsible Party):
Nanne Kleefstra, Medical Research Foundation, The Netherlands Identifier:
First received: March 29, 2012
Last updated: November 29, 2013
Last verified: November 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 Intervention
Diabetes Mellitus Type 2 Behavioral: Web portal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Large Scale Demonstrator, Webportal Diabetes

Further study details as provided by Nanne Kleefstra, Medical Research Foundation, The Netherlands:

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

Secondary Outcome Measures:
  • 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

  • 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
    • 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

Estimated Enrollment: 10000
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)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01570140

Contact: N Kleefstra, MD, PhD 0031-38-4244013

Isala Clinics Recruiting
Zwolle, Netherlands
Contact: N Kleefstra, MD, PhD    0031-38-4244013      
Sponsors and Collaborators
Nanne Kleefstra
University Medical Center Groningen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nanne Kleefstra, ass. professor, Medical Research Foundation, The Netherlands Identifier: NCT01570140     History of Changes
Other Study ID Numbers: LSD
Study First Received: March 29, 2012
Last Updated: November 29, 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on July 27, 2017