Clinical trial NCT01595269: The Clinical and Economic Impacts of e-Heath on Diabetes
Official title: The Clinical and Economic Impacts of e-Heath on Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
eHealth
Type 2 Diabetes
Education
Calgary Health Region
Lead sponsor: Pacaud, Danièle, M.D.
Sponsor class: INDIV
Collaborators: name: The Lawson Foundation
First posted: 2012-05-10
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project addresses the following Null Hypotheses:

1. There will be no difference will be found in the use of the search engine and the information accessed among the three education modes.
2. There will be no difference in education mode's effect on metabolic control, self-care management practices, and medical resource utilization.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in A1C
timeFrame: baseline, 3, 6, 9, 12 months
Secondary outcomes:
measure: a reduction in the cost of delivering health information and education processes
timeFrame: baseline and 12 months
measure: Changes in Diabetes Knowledge
timeFrame: baseline, 3, 6, 9, 12 months
measure: Changes in Diabetes self-care activities
timeFrame: Baseline, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Lethbridge
country: Canada
facility: Calgary Health Region's offices across southwestern Alberta
state: Alberta
Study officials:
affiliation: University of Lethbridge
name: Angela M Downey, PhD, CMA, FCMA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lethbridge
name: Helen Kelley, PhD
role: PRINCIPAL_INVESTIGATOR
References: