Diabetes MellitusPhase 3NCT01220310
Doctors and Web-based Self-management Support Pilot Study
A Phase 3 study testing Online diabetes workshop observation and learning sessions in people with Diabetes Mellitus, run by Stanford University at 4 sites in United States.
Trial summary
Doctors and web-based self-management support pilot study will test whether health professionals' observation of an online patient workshop on self-management of diabetes and participation in structured learning sessions on self-management strategies will change the attitudes and confidence of physicians and other… 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
- What is being tested?
- Online diabetes workshop observation and learning sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2008to Aug 2009
- Phase
- Phase 3
- 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
Inclusion Criteria:Health professional at primary care clinic of participating site identified by their residency director and/or clinic manager as having the schedule flexibility to attend (convenience sample). Can include physicians (residents and attendings), registered nurses, medical assistants, dieticians, community health workers, and the like. In the case of the residents, they will be on outpatient clinic blocks for the month of the learning sessions, and the program directors have the ability to free up their schedules to allow for participation in the learning sessions. Exclusion Criteria:The health professionals that do not want to participate, or are not working at one of partner sites, or the residency director and/or clinic manager determines that the health professional's schedule does not have the flexibility in it to allow for regular participation in the learning sessions.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alameda County Medical Center
Oakland, California, 94602
O'Connor Hospital
San Jose, California, 95128
Santa Clara Valley Medical Center
San Jose, California, 95128
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Doctors and Web-based Self-management Support Pilot Study.
Doctors and web-based self-management support pilot study will test whether health professionals' observation of an online patient workshop on self-management of diabetes and participation in structured learning sessions on self-management strategies will change the attitudes and confidence of physicians and other health professionals regarding their willingness and ability to perform self-management interventions with patients. If this pilot suggests that attitudes and confidence levels can change, we hope to launch a larger study to examine this method of learning and its effectiveness in more detail.
Read the detailed description
The standard of care is that health professionals receive their usual education on self-management, which ranges from minimal to modest, depending on the training site. They will be identified and invited to attend by the program director and/or clinic managers.
Health professional participants will attend 60-90 minutes teaching sessions with other health professionals, either in person or via Web-Ex, once per week for a total of 4 weeks. The program director and/or clinic managers overseeing these health professionals will make room for these sessions in their clinic schedule, so that you have no clinical or other responsibilities during those times.
During the first session, the Principal Investigator will first read the informed consent/fact sheet to the health professionals and ask for any questions. A copy of the informed consent/fact sheet will be given to each health professional participant, and they will be asked to provide their contact information on a sign up sheet. At that point, they will complete their first survey questionnaire.
Between these group sessions, at the convenience of the participant, the health professional will log-on to the online workshop to observe the patients' progress in the online course. The health professional will be expected to log on 3 times per week for approximately 10 minutes at a time. The health professional will have 2 'homework' assignments during the entire 4 weeks of learning sessions. These consist of thinking critically about how the self-management techniques they observe patients using online might apply to other patients the health professionals observe, whether online or in their clinics.
The health professionals will also be asked to complete voluntary pre- and post-course surveys. There will be time set aside during the first and last learning sessions for them to complete the surveys.
The final learning session will primarily be devoted to a focus group discussion of the learning sessions. The total time commitment to the observational learning sessions is to attend the 4 learning sessions (60-90 minutes apiece once per week), visit the patient online workshop site 3 times per week (for at least 10 minutes a time), and do the 'homework' assignments (which are expected to take 10-20 minutes apiece to complete).
The health professionals will not actually participate in the online workshop for patients. In fact, if they decide to participate in this project, they are instructed not interact in any way with the patients in the online workshop. The health professionals must agree to observe only, not to post on the discussion boards, and not to answer any messages that they may receive via the online messaging system. The workshops are monitored by Stanford staff, and they will take any action necessary if the health professionals alert them to the need to respond to a patient.
- Conditions
- Diabetes Mellitus
- Being tested
- Online diabetes workshop observation and learning sessions
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online diabetes workshop observation and learning sessionsBehavioural
We will, by self-administered pre- and post-intervention surveys, evaluate the effectiveness of the online diabetes workshop observations and learning sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Online diabetes workshop observation and learning sessions Receives: Behavioral: Online diabetes workshop observation and learning sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 3
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Clara Valley Medical Center, Alameda County Medical Center
- Responsible party
- Principal investigator, Kate Lorig, Stanford University
- Investigators
- Kate R Lorig, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220310
- Sponsor's protocol ID
- SU-09242008-1309
- Other IDs
- IRB Protocol ID: 15108
- Status last verified
- Apr 2016
- First submitted
- 12 Aug 2010
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doctors and Web-based Self-management Support Pilot Study.
- ClinicalTrials.gov ID
- NCT01220310
- Acronym / sponsor ID
- SU-09242008-1309
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Santa Clara Valley Medical Center, Alameda County Medical Center
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Oct 2010 (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.
Doctors and web-based self-management support pilot study will test whether health professionals' observation of an online patient workshop on self-management of diabetes and participation in structured learning sessions on self-management strategies will change the attitudes and confidence of physicians and other health professionals regarding their willingness and ability to perform self-management interventions with patients. If this pilot suggests that attitudes and confidence levels can change, we hope to launch a larger study to examine this method of learning and its effectiveness in more detail.
Detailed description
The standard of care is that health professionals receive their usual education on self-management, which ranges from minimal to modest, depending on the training site. They will be identified and invited to attend by the program director and/or clinic managers.
Health professional participants will attend 60-90 minutes teaching sessions with other health professionals, either in person or via Web-Ex, once per week for a total of 4 weeks. The program director and/or clinic managers overseeing these health professionals will make room for these sessions in their clinic schedule, so that you have no clinical or other responsibilities during those times.
During the first session, the Principal Investigator will first read the informed consent/fact sheet to the health professionals and ask for any questions. A copy of the informed consent/fact sheet will be given to each health professional participant, and they will be asked to provide their contact information on a sign up sheet. At that point, they will complete their first survey questionnaire.
Between these group sessions, at the convenience of the participant, the health professional will log-on to the online workshop to observe the patients' progress in the online course. The health professional will be expected to log on 3 times per week for approximately 10 minutes at a time. The health professional will have 2 'homework' assignments during the entire 4 weeks of learning sessions. These consist of thinking critically about how the self-management techniques they observe patients using online might apply to other patients the health professionals observe, whether online or in their clinics.
The health professionals will also be asked to complete voluntary pre- and post-course surveys. There will be time set aside during the first and last learning sessions for them to complete the surveys.
The final learning session will primarily be devoted to a focus group discussion of the learning sessions. The total time commitment to the observational learning sessions is to attend the 4 learning sessions (60-90 minutes apiece once per week), visit the patient online workshop site 3 times per week (for at least 10 minutes a time), and do the 'homework' assignments (which are expected to take 10-20 minutes apiece to complete).
The health professionals will not actually participate in the online workshop for patients. In fact, if they decide to participate in this project, they are instructed not interact in any way with the patients in the online workshop. The health professionals must agree to observe only, not to post on the discussion boards, and not to answer any messages that they may receive via the online messaging system. The workshops are monitored by Stanford staff, and they will take any action necessary if the health professionals alert them to the need to respond to a patient.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Online diabetes workshop observation and learning sessionsOnline diabetes workshop observation and learning sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Online diabetes workshop observation and learning sessionsWe will, by self-administered pre- and post-intervention surveys, evaluate the effectiveness of the online diabetes workshop observations and learning sessions. | Behavioural | Intervention |
Primary outcome
Self-Efficacy
Time frame: 1 month
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 19 Apr 2016.
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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.
Kate R Lorig principal investigator
Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Online diabetes workshop observation and learning sessions in people with Diabetes Mellitus, run by Stanford University at 4 sites 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?
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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Self-Efficacy (time frame: 1 month). 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 19 Apr 2016.