Diabetes Mellitus, Type 2eHealthDMNCT01595269
The Clinical and Economic Impacts of e-Heath on Diabetes
A study testing eHealth education in people with Diabetes Mellitus, Type 2, run by Dr. Danièle Pacaud at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- eHealth education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No linguistic, cognitive or psychosocial barriers that would hinder study completion
- Computer and internet literate
- Access to high-speed internet
Who cannot join
- Under the age of 18
- Not literate
- Participating in other clinical trials
- Diabetes diagnosed greater than three months ago
- Type 1 diabetes
- Gestational diabetes
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Calgary Health Region's offices across southwestern Alberta
Lethbridge, Alberta
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- eHealth education
- Keywords
- Diabetes, eHealth, Type 2 Diabetes, Education, Calgary Health Region
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth educationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: eHealth education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3, 6, 9, 12 months
Secondary outcomes (3)
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.
Measured: baseline and 12 months
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.
Measured: baseline, 3, 6, 9, 12 months
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).
Measured: Baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Danièle Pacaud
- Collaborators
- The Lawson Foundation
- Responsible party
- Sponsor-investigator, Dr. Danièle Pacaud, Pacaud, Danièle, M.D.
- Investigators
- Angela M Downey, PhD, CMA, FCMA, Principal investigator, University of LethbridgeHelen Kelley, PhD, Principal investigator, University of Lethbridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595269
- Sponsor's protocol ID
- LAWSON-686
- Acronym
- eHealthDM
- Status last verified
- May 2012
- First submitted
- 3 Mar 2011
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Economic Impacts of e-Heath on Diabetes
- ClinicalTrials.gov ID
- NCT01595269
- Acronym / sponsor ID
- eHealthDM / LAWSON-686
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, eHealth, Type 2 Diabetes, Education, Calgary Health Region
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Dr. Danièle Pacaud
- Collaborators
- The Lawson Foundation
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education mode 1 (control) | Placebo comparator | Other: eHealth educationEducation 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) | Active comparator | Other: eHealth educationEducation 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) | Active comparator | Other: eHealth educationEducation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 or older
- Literate
- Not participating in other clinical trials
- Diabetes diagnosed within the last three months
- Type 2 diabetes
Key exclusion criteria (10 listed)
- Under the age of 18
- Not literate
- Participating in other clinical trials
- Diabetes diagnosed greater than three months ago
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth educationIn 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. | Other | Education mode 1 (control), Education mode 2 (static interface), Education mode 3 (dynamic interface) |
Primary outcome
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.
3 secondary outcomes
a reduction in the cost of delivering health information and education processes
Time frame: baseline and 12 months
Changes in Diabetes Knowledge
Time frame: baseline, 3, 6, 9, 12 months
Changes in Diabetes self-care activities
Time frame: Baseline, 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Downey, PhD, CMA, FCMA principal investigator
University of Lethbridge
Helen Kelley, PhD principal investigator
University of Lethbridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth education in people with Diabetes Mellitus, Type 2, run by Dr. Danièle Pacaud at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in A1C (time frame: baseline, 3, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.