The Clinical and Economic Impacts of e-Heath on Diabetes

NCT01595269 | Completed

• 1 other identifier: LAWSON-686
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This project addresses the following Null Hypotheses:

1. 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. 2.There will be no difference in education mode's effect on metabolic control, self-care management practices, and medical resource utilization.
3. 3.There will be no difference in the economic impact on the health care system based on differing education modes.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; eHealth; Type 2 Diabetes; Education; Calgary Health Region

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 3, 6, 9, 12 months

Secondary Outcomes (3)

• a reduction in the cost of delivering health information and education processes

  baseline and 12 months

• Changes in Diabetes Knowledge

  baseline, 3, 6, 9, 12 months

• Changes in Diabetes self-care activities

  Baseline, 3, 6, 9 and 12 months

Study Arms (3)

Education mode 1 (control)

PLACEBO COMPARATOR

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

Education mode 2 (static interface)

ACTIVE COMPARATOR

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

Education mode 3 (dynamic interface)

ACTIVE COMPARATOR

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

Interventions

eHealth education 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 1 (control); Education mode 2 (static interface); Education mode 3 (dynamic interface)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Danièle Pacaud: lead
• The Lawson Foundation: collaborator

Study Sites (1)

Calgary Health Region's offices across southwestern Alberta

Lethbridge, Alberta, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Angela M Downey, PhD, CMA, FCMA

  University of Lethbridge

  PRINCIPAL INVESTIGATOR

• Helen Kelley, PhD

  University of Lethbridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: May 10, 2012
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

CA (1)