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

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ClinicalTrials.gov Identifier: NCT01595269
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : May 10, 2012
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Dr. Danièle Pacaud, Pacaud, Danièle, M.D.

Tracking Information
First Submitted Date  ICMJE March 3, 2011
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date May 10, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • a reduction in the cost of delivering health information and education processes [ Time Frame: 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.
  • Changes in Diabetes Knowledge [ Time Frame: 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.
  • Changes in Diabetes self-care activities [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Clinical and Economic Impacts of e-Heath on Diabetes
Official Title  ICMJE The Clinical and Economic Impacts of e-Heath on Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • Placebo Comparator: 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.
    Intervention: Other: eHealth education
  • Active Comparator: 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.
    Intervention: Other: eHealth education
  • Active Comparator: 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.
    Intervention: Other: eHealth education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2012)
79
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595269
Other Study ID Numbers  ICMJE LAWSON-686
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Danièle Pacaud, Pacaud, Danièle, M.D.
Study Sponsor  ICMJE Dr. Danièle Pacaud
Collaborators  ICMJE The Lawson Foundation
Investigators  ICMJE
Principal Investigator: Angela M Downey, PhD, CMA, FCMA University of Lethbridge
Principal Investigator: Helen Kelley, PhD University of Lethbridge
PRS Account Pacaud, Danièle, M.D.
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP