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Web-based Education for Diabetes Patients on Adaptable Insulin Schedules (Telediabetes)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University Hospital, Ghent
Sponsor:
Collaborator:
AZ Nikolaas
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01619592
First received: June 12, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

Inclusion criteria: adult diabetes patients on multiple daily insulin injections or using an insulin pump; Internet users Exclusion criteria: having a severe mental illness Patients will be recruited during the conventional consult. If they want to participate, they will get detailed information regarding the study; after giving consent; they will sign the informed consent form and they will get a unique study number.

The patient will than complete a questionnaire on a secured website (https://) using the unique study number. After completing this questionnaire, the patient will be randomised either into a group 'standard care + direct start with web-based diabetes education' (intervention group) or they will enter into the other group (control) receiving standard care. Three months after the start of the study, all patients will be asked to complete the questionnaire again and the patients into the control group will also get access to 'standard care + web-based diabetes education'. The questionnaire will have to be completed on months 6, year 1 and year 2. At the time of completing the questionnaire, HbA1c will be determined. This is part of the routine examination in each participating hospital (UZGent and AZ Nikolaas). The determination of HbA1c is not study-specific but the value will be taken into the study.

The web-based questionnaire:

Patients will enter on a website including general study-information. They also have to explicitly click a button to proceed to the questionnaire. After clicking on 'I am prepared to participate in the study' they will see a second webpage retrieving some general information. After receiving this real basic information; they will be redirected to a secure website (https://) and will make use of a unique study number. Only the main researcher will have the possibility to link the general information to the unique study number.

The informed consent form:

The patient will be asked for added information. He/she will have to sign specific pages giving explicitly informed consent for information retrieved from the 'mutualiteit' (National Health Service - NHS).

On the NHS information will be asked regarding the health costs. These figures should make it possible to have a more objective figure of the costs associated to diabetes (care).

The patient can stop on every moment the study participation. Once decided he/she wants to stop, he/she will receive standard care.

Study hypotheses: the QoL will improve by the use of web-based diabetes education; there will be a reduction in costs using web-based diabetes education; there will be at least an equal-stay or improvement of the HbA1c while using web-based diabetes education.


Condition Intervention
Diabetes
Device: webbased education (telemonitoring)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Belgian Quality of Life and Costs Study on Web-based Education for Diabetes Patients on Adaptable Insulin Schedules

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Quality of Life (QoL) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire

  • Quality of Life (QoL) [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire

  • Quality of Life (QoL) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire

  • Quality of Life (QoL) [ Time Frame: year 1 ] [ Designated as safety issue: No ]
    QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire

  • Quality of Life (QoL) [ Time Frame: year 2 ] [ Designated as safety issue: No ]
    QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention group
webbased education (telemonitoring)
Device: webbased education (telemonitoring)
Patients will be able to transmit their blood glucose values via the Internet to the diabetes professional and they will receive timely feedback. "Timely" will be defined as 'as agreed between the patient and the diabetes professional', e.g. every week on Friday afternoon.
No Intervention: control group
standard care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult diabetes patients on multiple daily insulin injections or using an insulin pump;
  • Internet users

Exclusion Criteria:

  • having a severe mental illness
  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: NCT01619592

Contacts
Contact: Heidi Buysse, Phd heidi.buysse@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Heidi Buysse, Phd       heidi.buysse@ugent.be   
Principal Investigator: Heidi Buysse, Phd         
AZ Nikolaas: Department of Endocrinology Recruiting
Sint-Niklaas, Belgium, 9100
Contact: Peter Coremans, MD         
Sub-Investigator: Peter Coremans, MD         
Sponsors and Collaborators
University Hospital, Ghent
AZ Nikolaas
Investigators
Study Director: Johannes Ruige, MD, Phd Ghent University Hospital
Principal Investigator: Heidi Buysse, Phd Ghent University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01619592     History of Changes
Other Study ID Numbers: 2012/321
Study First Received: June 12, 2012
Last Updated: August 23, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
patients
adaptable
insulin
schemes

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014