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

This study has been completed.
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Dr. Danièle Pacaud, Pacaud, Danièle, M.D.
ClinicalTrials.gov Identifier:
NCT01595269
First received: March 3, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.

Condition Intervention
Diabetes Mellitus, Type 2
Other: eHealth education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Clinical and Economic Impacts of e-Heath on Diabetes

Resource links provided by NLM:


Further study details as provided by Pacaud, Danièle, M.D.:

Primary Outcome Measures:
  • Changes in A1C [ Time Frame: baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 79
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595269

Locations
Canada, Alberta
Calgary Health Region's offices across southwestern Alberta
Lethbridge, Alberta, Canada
Sponsors and Collaborators
Dr. Danièle Pacaud
The Lawson Foundation
Investigators
Principal Investigator: Angela M Downey, PhD, CMA, FCMA University of Lethbridge
Principal Investigator: Helen Kelley, PhD University of Lethbridge
  More Information

No publications provided

Responsible Party: Dr. Danièle Pacaud, Associate Professor, Pacaud, Danièle, M.D.
ClinicalTrials.gov Identifier: NCT01595269     History of Changes
Other Study ID Numbers: LAWSON-686
Study First Received: March 3, 2011
Last Updated: May 8, 2012
Health Authority: Canada: Health Canada

Keywords provided by Pacaud, Danièle, M.D.:
Diabetes
eHealth
Type 2 Diabetes
Education
Calgary Health Region

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014