The Clinical and Economic Impacts of e-Heath on Diabetes (eHealthDM)
8 mei 2012 bijgewerkt door: Dr. Danièle Pacaud
This project addresses the following Null Hypotheses:
- There will be no difference will be found in the use of the search engine and the information accessed among the three education modes.
- There will be no difference in education mode's effect on metabolic control, self-care management practices, and medical resource utilization.
- There will be no difference in the economic impact on the health care system based on differing education modes.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
In addition to the face-to-face education process currently used at the CHR, this project will develop two modes of eHealth education.
Education mode 1 (control) is comprised of participants educated using CHR's current traditional face-to-face delivery method, with printed materials and written log journals.
These participants will be trained to use the University's web portal if they elect to access internet-based diabetes information.
This allows for the tracking of the type and amounts of diabetes information accessed by participants.
Education mode 2 (static interface) participants will be educated using digitized forms of the traditional materials provided by CHR as well as an electronic log journal (e-journal) where participants will record their diabetes-related outcomes and behavioural information.
Education mode 2 will be assessed and approved by CHR.
Education mode 3 (dynamic interface) participants will be educated using the digitized traditional materials from education mode 2 as well as an enhanced dynamic e-journal (visualization of blood glucose and alerts).
In addition, this mode will provide informative disease-related internet sites and diabetes news and articles vetted by the medical team.
Participants and health professionals will then be able to electronically discuss the content and quality of this information (discussion board).
New sites and articles will be added on an ongoing basis.
Participants will also have access to a chat room that will encourage information sharing with other education mode 3 participants and health professionals at CHR. Education mode 3 will be assessed and approved by CHR.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
79
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Alberta
-
Lethbridge, Alberta, Canada
- Calgary Health Region's offices across southwestern Alberta
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Aged 18 or older
- Literate
- Not participating in other clinical trials
- Diabetes diagnosed within the last three months
- Type 2 diabetes
- No medical conditions that could compromise metabolic control
- No linguistic, cognitive or psychosocial barriers that would hinder study completion
- Computer and internet literate
- Access to high-speed internet
Exclusion Criteria:
- Under the age of 18
- Not literate
- Participating in other clinical trials
- Diabetes diagnosed greater than three months ago
- Type 1 diabetes
- Gestational diabetes
- Additional medical conditions that could compromise metabolic control
- Linguistic, cognitive or psychosocial barriers that would hinder study completion
- Not computer and internet literate
- No access to high-speed internet
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Education mode 1 (control)
Education mode 1 (control) is comprised of participants educated using CHR's current traditional face-to-face delivery method, with printed materials and written log journals.
These participants will be trained to use the University's web portal if they elect to access internet-based diabetes information.
This allows for the tracking of the type and amounts of diabetes information accessed by participants.
|
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
|
|
Actieve vergelijker: Education mode 2 (static interface)
Education mode 2 (static interface) participants will be educated using digitized forms of the traditional materials provided by CHR as well as an electronic log journal (e-journal) where participants will record their diabetes-related outcomes and behavioural information.
Education mode 2 will be assessed and approved by CHR.
|
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
|
|
Actieve vergelijker: Education mode 3 (dynamic interface)
Education mode 3 (dynamic interface) participants will be educated using the digitized traditional materials from education mode 2 as well as an enhanced dynamic e-journal (visualization of blood glucose and alerts).
In addition, this mode will provide informative disease-related internet sites and diabetes news and articles vetted by the medical team.
Participants and health professionals will then be able to electronically discuss the content and quality of this information (discussion board).
New sites and articles will be added on an ongoing basis.
Participants will also have access to a chat room that will encourage information sharing with other education mode 3 participants and health professionals at CHR. Education mode 3 will be assessed and approved by CHR.
|
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in A1C
Tijdsspanne: baseline, 3, 6, 9, 12 months
|
A1C is a measure of metabolic control in diabetes.
For this study changes in A1C from baseline to 3, 6, 9 and 12 months were measured.
All A1C were measured in provincial laboratories using 6.1% as the upper limit of normal for individuals without diabetes.
|
baseline, 3, 6, 9, 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
a reduction in the cost of delivering health information and education processes
Tijdsspanne: baseline and 12 months
|
Secondary effects could include a change in the cost of delivering health information and education processes.
Potential changes to self-care management practices of people with type II diabetes could lead to a reduced utilization of the heath care system resulting in a positive economic impact.
|
baseline and 12 months
|
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Changes in Diabetes Knowledge
Tijdsspanne: baseline, 3, 6, 9, 12 months
|
Changes in diabetes knowledge from baseline to 3, 6, 9, and 12 months will be measured using a 23 item multiple choice questionnaire devolopped by Fitzgerald et al 1998.
|
baseline, 3, 6, 9, 12 months
|
|
Changes in Diabetes self-care activities
Tijdsspanne: Baseline, 3, 6, 9 and 12 months
|
Changes in diabetes self-care activities from base line to 3, 6, 9, and 12 months will be measured the diabetes self-care activities tool evaluated by Toobert at al (2000).
|
Baseline, 3, 6, 9 and 12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Angela M Downey, PhD, CMA, FCMA, University of Lethbridge
- Hoofdonderzoeker: Helen Kelley, PhD, University of Lethbridge
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2007
Primaire voltooiing (Werkelijk)
1 december 2008
Studie voltooiing (Werkelijk)
1 december 2009
Studieregistratiedata
Eerst ingediend
3 maart 2011
Eerst ingediend dat voldeed aan de QC-criteria
8 mei 2012
Eerst geplaatst (Schatting)
10 mei 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
10 mei 2012
Laatste update ingediend die voldeed aan QC-criteria
8 mei 2012
Laatst geverifieerd
1 mei 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LAWSON-686
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