Large Scale Demonstrator, Webportal Diabetes (LSD)

March 20, 2018 updated by: Henk Bilo, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life
Time Frame: 12 months
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
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
12 months
Diabetes-related distress
Time Frame: 12 months
PAID-5, questionnaire for diabetes-related distress
12 months
Assessing self-efficacy
Time Frame: 12 months
SDSCA, assessing self-efficacy
12 months
Evaluation of general practice
Time Frame: 12 months
Europep questionnaire, evaluation of general practice
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henk Bilo, MD

Collaborators

University Medical Center Groningen
Isala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

April 1, 2012

First Posted (ESTIMATE)

April 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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