Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Large Scale Demonstrator, Webportal Diabetes (LSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medical Research Foundation, The Netherlands
Sponsor:
Collaborators:
Isala
University Medical Centre Groningen
Information provided by (Responsible Party):
Nanne Kleefstra, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT01570140
First received: March 29, 2012
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • 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
    • Relaxation
    • 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
    • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  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 ClinicalTrials.gov identifier: NCT01570140

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

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

No publications provided

Responsible Party: Nanne Kleefstra, ass. professor, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01570140     History of Changes
Other Study ID Numbers: LSD
Study First Received: March 29, 2012
Last Updated: November 29, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014