Diabetes Mellitus, Type 2NCT00194506
Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
A study testing Internet co-management module in people with Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
Trial summary
This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Internet co-management module
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to May 2006
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- computer and Internet access at home
- receiving care for type 2 diabetes at the University of Washington, General Internal Medicine Clinic, Roosevelt
Who cannot join
- non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, General Internal Medicine Clinic, Roosevelt
Seattle, Washington, 98195
About this study
This is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.
Read the detailed description
We will conduct a randomized controlled trial to determine whether a fully computerized, diabetes mellitus (DM) disease-management module (known as Cyber-DM) can improve the quality of adult diabetes care. The module will be Web-based, include a graphical HTML "front end" user interface, and will be incorporated into each patient's existing Web-based electronic medical record --the Medical Information Networked Database (MIND) repository at the University of Washington Academic Medical Centers. This Web site will include five components that will enable patients to interact asynchronously from their homes with their clinic-based providers:
- An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials.
- Real-time clinical reminders of the need to obtain preventive services such as HbA1c, urine-protein and cholesterol determinations, and retinal examinations.
- An electronic version of the SDMTM diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise.
- The ability to download glucometer readings and medication-use information from home directly into the MIND repository.
- Secure email communication between patients, their primary care physicians, and clinic staff.
A total of 80-85 diabetic patients who are regular utilizers of the UW's General Internal Medicine Clinic and who have home Internet access will be randomized to the experimental and control arms of the trial. Control subjects will receive usual care. We hypothesize that use of Cyber-DM will increase compliance with guideline-indicated care processes, improve glycemic control, and reduce utilization costs. A trial this size would have the statistical power to detect a change in HbA1c of 0.50%. Secure Socket Layer technology, session specific "cookie" files, and a custom database application that manages logins/passwords and audits all accesses to the system will provide security for this information tool.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Internet co-management module
- Keywords
- Diabetes, Health Education, Information Technology, Disease Management, Internet, Patient Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet co-management moduleBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Secondary outcomes (1)
Utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2002
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Management Research
- Investigators
- Harold I. Goldberg, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194506
- Sponsor's protocol ID
- 00-3882-E/A 05
- Status last verified
- Apr 2006
- First submitted
- 12 Sep 2005
- Last updated
- 14 Apr 2006
- Results posted
- No
Publications
Ralston JD, Hirsch IB, Hoath J, Mullen M, Cheadle A, Goldberg HI. Web-based collaborative care for type 2 diabetes: a pilot randomized trial. Diabetes Care. 2009 Feb;32(2):234-9. doi: 10.2337/dc08-1220. Epub 2008 Nov 18.
PubMed 19017773
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
- ClinicalTrials.gov ID
- NCT00194506
- Acronym / sponsor ID
- 00-3882-E/A 05
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Health Education, Information Technology, Disease Management, Internet, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Center for Health Management Research
- Study start
- Aug 2002
- Study completion
- May 2006
- First posted
- 19 Sep 2005 (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 is a 12-month randomized, controlled trial of a Web-based diabetes co-management module among type 2 patients at the University of Washington's Roosevelt General Internal Medicine Clinic.
Detailed description
We will conduct a randomized controlled trial to determine whether a fully computerized, diabetes mellitus (DM) disease-management module (known as Cyber-DM) can improve the quality of adult diabetes care. The module will be Web-based, include a graphical HTML "front end" user interface, and will be incorporated into each patient's existing Web-based electronic medical record --the Medical Information Networked Database (MIND) repository at the University of Washington Academic Medical Centers. This Web site will include five components that will enable patients to interact asynchronously from their homes with their clinic-based providers:
- An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials.
- Real-time clinical reminders of the need to obtain preventive services such as HbA1c, urine-protein and cholesterol determinations, and retinal examinations.
- An electronic version of the SDMTM diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise.
- The ability to download glucometer readings and medication-use information from home directly into the MIND repository.
- Secure email communication between patients, their primary care physicians, and clinic staff.
A total of 80-85 diabetic patients who are regular utilizers of the UW's General Internal Medicine Clinic and who have home Internet access will be randomized to the experimental and control arms of the trial. Control subjects will receive usual care. We hypothesize that use of Cyber-DM will increase compliance with guideline-indicated care processes, improve glycemic control, and reduce utilization costs. A trial this size would have the statistical power to detect a change in HbA1c of 0.50%. Secure Socket Layer technology, session specific "cookie" files, and a custom database application that manages logins/passwords and audits all accesses to the system will provide security for this information tool.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- computer and Internet access at home
- receiving care for type 2 diabetes at the University of Washington, General Internal Medicine Clinic, Roosevelt
Key exclusion criteria (1 listed)
- non-English speaking
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 |
|---|---|---|
| Internet co-management module | Behavioural | – |
Primary outcome
Hemoglobin A1c
1 secondary outcome
Utilization
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 14 Apr 2006.
- Derived from this study: PubMed 19017773Ralston JD, Hirsch IB, Hoath J, Mullen M, Cheadle A, Goldberg HI. Web-based collaborative care for type 2 diabetes: a pilot randomized trial. Diabetes Care. 2009 Feb;32(2):234-9. doi: 10.2337/dc08-1220. Epub 2008 Nov 18.
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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.
Harold I. Goldberg, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet co-management module in people with Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
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 2 inclusion and 1 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 14 Apr 2006. 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 United States. 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. 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?
Hemoglobin A1c. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00194506, which also lists 1 linked publication.
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 14 Apr 2006.