Diabetes Mellitus, Type 2NCT00119938
An Online System to Improve Diabetes Self-Care
A study testing Access to online patient portal in people with Diabetes Mellitus, Type 2, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
The purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Access to online patient portal
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 331 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 2 diabetes mellitus
- Has access to Internet
- Has e-mail address
- Established patient at one of four participating practices at University of Colorado Hospital
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: D-STAR (Diabetes-System To Access Records): An Online Patient Portal to Improve and Sustain Diabetes Self-Care
The purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke).
Read the detailed description
Patient portals are online programs that can provide a number of functions for patients, among them:
- Ability to request appointments, referrals, and medication refills;
- Ability to send secure electronic messages to medical staff, and to receive replies;
- Access to the medical record;
- Disease management
We are comparing two patient portals with different sets of features to determine if personalized information and guidance can improve self-care and measures of diabetes-related health. Self-care measures will be assessed using standardized questionnaires at baseline, 3, and 6 months. Chart review will be used to assess measures of diabetes-related health.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Access to online patient portal
- Keywords
- Disease management, Patient access to records, Medical records systems, computerized, Questionnaires, Physician-patient relations, Medical records
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to online patient portalBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of diabetes self-care activities, developed from the Summary of Diabetes Self-Care Measure
Measured: Surveys at baseline, 3 months, and 6 months
Secondary outcomes (2)
Qualitative assessment of the program by patients and medical staff
Measured: Interviews after 9 months of deployment
Biological markers of diabetes care (hemoglobin A1c, blood pressure, LDL cholesterol)
Measured: Incidentally obtained over 9 months of care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startSep 2004
- Study completionDec 2006
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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Stephen E Ross, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119938
- Sponsor's protocol ID
- 51758
- Status last verified
- Jul 2007
- First submitted
- 6 Jul 2005
- Last updated
- 20 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-STAR (Diabetes-System To Access Records): An Online Patient Portal to Improve and Sustain Diabetes Self-Care
- ClinicalTrials.gov ID
- NCT00119938
- Acronym / sponsor ID
- 51758
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Disease management, Patient access to records, Medical records systems, computerized, Questionnaires, Physician-patient relations, Medical records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke).
Detailed description
Patient portals are online programs that can provide a number of functions for patients, among them:
- Ability to request appointments, referrals, and medication refills;
- Ability to send secure electronic messages to medical staff, and to receive replies;
- Access to the medical record;
- Disease management
We are comparing two patient portals with different sets of features to determine if personalized information and guidance can improve self-care and measures of diabetes-related health. Self-care measures will be assessed using standardized questionnaires at baseline, 3, and 6 months. Chart review will be used to assess measures of diabetes-related health.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Type 2 diabetes mellitus
- Has access to Internet
- Has e-mail address
- Established patient at one of four participating practices at University of Colorado Hospital
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 |
|---|---|---|
| Access to online patient portal | Behavioural | – |
Primary outcome
Composite measure of diabetes self-care activities, developed from the Summary of Diabetes Self-Care Measure
Time frame: Surveys at baseline, 3 months, and 6 months
2 secondary outcomes
Qualitative assessment of the program by patients and medical staff
Time frame: Interviews after 9 months of deployment
Biological markers of diabetes care (hemoglobin A1c, blood pressure, LDL cholesterol)
Time frame: Incidentally obtained over 9 months of care
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 20 Aug 2008.
- Website for Health e-Technologies Initiative, a national program office of the Robert Wood Johnson FoundationLink provided by the sponsor.
- Website for University of Colorado Hospital, the site of the studyLink provided by the sponsor.
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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.
Stephen E Ross, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to online patient portal in people with Diabetes Mellitus, Type 2, run by Robert Wood Johnson Foundation 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 4 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 20 Aug 2008. 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?
Composite measure of diabetes self-care activities, developed from the Summary of Diabetes Self-Care Measure (time frame: Surveys at baseline, 3 months, and 6 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 20 Aug 2008.