The Clinical and Economic Impacts of e-Heath on Diabetes

NCT ID: NCT01595269

Last Updated: 2012-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

eHealth education

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

eHealth education

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

eHealth education

Intervention Type OTHER

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.

Interventions

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eHealth education

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Lawson Foundation

OTHER

Sponsor Role collaborator

Dr. Danièle Pacaud

INDIV

Sponsor Role lead

Responsible Party

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Dr. Danièle Pacaud

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Angela M Downey, PhD, CMA, FCMA

Role: PRINCIPAL_INVESTIGATOR

University of Lethbridge

Helen Kelley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lethbridge

Locations

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Calgary Health Region's offices across southwestern Alberta

Lethbridge, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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LAWSON-686

Identifier Type: -

Identifier Source: org_study_id

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