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The Clinical and Economic Impacts of e-Heath on Diabetes (eHealthDM)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
eHealth education
Sponsored by
Dr. Danièle Pacaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, eHealth, Type 2 Diabetes, Education, Calgary Health Region

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Calgary Health Region's offices across southwestern Alberta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Education mode 1 (control)

Education mode 2 (static interface)

Education mode 3 (dynamic interface)

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in A1C
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 Outcome Measures

a reduction in the cost of delivering health information and education processes
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.
Changes in Diabetes Knowledge
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.
Changes in Diabetes self-care activities
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).

Full Information

First Posted
March 3, 2011
Last Updated
May 8, 2012
Sponsor
Dr. Danièle Pacaud
Collaborators
The Lawson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01595269
Brief Title
The Clinical and Economic Impacts of e-Heath on Diabetes
Acronym
eHealthDM
Official Title
The Clinical and Economic Impacts of e-Heath on Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Danièle Pacaud
Collaborators
The Lawson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, eHealth, Type 2 Diabetes, Education, Calgary Health Region

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education mode 1 (control)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Education mode 2 (static interface)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Education mode 3 (dynamic interface)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
eHealth education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in A1C
Description
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.
Time Frame
baseline, 3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
a reduction in the cost of delivering health information and education processes
Description
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.
Time Frame
baseline and 12 months
Title
Changes in Diabetes Knowledge
Description
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.
Time Frame
baseline, 3, 6, 9, 12 months
Title
Changes in Diabetes self-care activities
Description
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).
Time Frame
Baseline, 3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela M Downey, PhD, CMA, FCMA
Organizational Affiliation
University of Lethbridge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helen Kelley, PhD
Organizational Affiliation
University of Lethbridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary Health Region's offices across southwestern Alberta
City
Lethbridge
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

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The Clinical and Economic Impacts of e-Heath on Diabetes

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