The Clinical and Economic Impacts of e-Heath on Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Changes in A1C
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 or older
- •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
Outcomes
Primary Outcomes
Changes in A1C
Time Frame: 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.
Secondary Outcomes
- a reduction in the cost of delivering health information and education processes(baseline and 12 months)
- Changes in Diabetes Knowledge(baseline, 3, 6, 9, 12 months)
- Changes in Diabetes self-care activities(Baseline, 3, 6, 9 and 12 months)
Investigators
Dr. Danièle Pacaud
Associate Professor
Pacaud, Danièle, M.D.