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Completed

NCT Number: NCT01570140

Large Scale Demonstrator, Webportal Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Isala Clinics

Zwolle, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web portal

Behavioral

This study investigates the effects of the voluntarily use of a webportal and its educational content.

Primary outcomes

  1. Health Related Quality of Life

    Time frame: 12 months

    EQ-5D questionnaire, representing Health Related Quality of Life dimension

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Henk Bilo, MD

Other

Collaborators

  • Isala
  • University Medical Center Groningen

Registry information

Acronym: LSD

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2012
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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