Web-based Education for Diabetes Patients on Adaptable Insulin Schedules (Telediabetes)
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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 |
- 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 |
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| Contact: Heidi Buysse, Phd | heidi.buysse@ugent.be |
| 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 | |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012
