Diabetes Mellitus, Type 2NCT00185601
Internet Diabetes Self-Management Workshop
A study testing Internet Diabetes Self-Management Program in people with Diabetes Mellitus, Type 2, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine of the effectiveness of an Internet based Diabetes Self-Management workshop for people with type II diabetes. Half of the people who complete the workshop will be invited to continue their education by participating in a email discussion group. 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?
- Internet Diabetes Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 761 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2010
- 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
- Have internet access and email address
- Live in the United States
- 18 years of age or older Exclusion Criteria:- Previous participation in similar online or community-based self-management program
- Active treatment for cancer
- Pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Internet Diabetes Self-Management Evaluation
The purpose of this study is to determine of the effectiveness of an Internet based Diabetes Self-Management workshop for people with type II diabetes. Half of the people who complete the workshop will be invited to continue their education by participating in a email discussion group. Thus, we will be able to learn both the efficacy of the original program as well as its efficacy when reinforced by the discussion group.
Diabetes is a disease that must be managed day by day by the individual with the disease. Although we know a great deal about the self-management of type II diabetes, most self-management is less than optimal. In addition, most people with diabetes do not have an opportunity to participate in formal diabetes education. This study will determine if an Internet delivered educational workshop will help people with diabetes manage their disease. Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c, blood pressure, cholesterol, and weight. If successful the workshop will serve as a prototype for Internet diabetes education.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Internet Diabetes Self-Management Program
- 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.
Internet Diabetes Self-Management ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| on-line self management intervention | Other | Not described Receives: Behavioral: Internet Diabetes Self-Management Program |
| usual care control group | No intervention | Not described |
| on-line self management intervention with email reinforcement | Experimental | Not described Receives: Behavioral: Internet Diabetes Self-Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 6 and 12 months
Secondary outcomes (3)
Outcome Measure: Health-related quality of life
Measured: 6 and 12 months
Outcome Measure: Health behaviors
Measured: 6 and 12 months
Health care utilization
Measured: 6 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 posted16 Sep 2005 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionJun 2010
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Lorig, Stanford University
- Investigators
- Kate R Lorig, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185601
- Sponsor's protocol ID
- 5R18DK065729-02
- Status last verified
- Apr 2013
- First submitted
- 9 Sep 2005
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Case S, Jernigan V, Gardner A, Ritter P, Heaney CA, Lorig KR. Content and frequency of writing on diabetes bulletin boards: does race make a difference? J Med Internet Res. 2009 Jun 24;11(2):e22. doi: 10.2196/jmir.1153.
PubMed 19632975
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Diabetes Self-Management Evaluation
- ClinicalTrials.gov ID
- NCT00185601
- Acronym / sponsor ID
- 5R18DK065729-02
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 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.
The purpose of this study is to determine of the effectiveness of an Internet based Diabetes Self-Management workshop for people with type II diabetes. Half of the people who complete the workshop will be invited to continue their education by participating in a email discussion group. Thus, we will be able to learn both the efficacy of the original program as well as its efficacy when reinforced by the discussion group.
Diabetes is a disease that must be managed day by day by the individual with the disease. Although we know a great deal about the self-management of type II diabetes, most self-management is less than optimal. In addition, most people with diabetes do not have an opportunity to participate in formal diabetes education. This study will determine if an Internet delivered educational workshop will help people with diabetes manage their disease. Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c, blood pressure, cholesterol, and weight. If successful the workshop will serve as a prototype for Internet diabetes education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| on-line self management intervention | Other | Behavioral: Internet Diabetes Self-Management Program |
| usual care control group | No intervention | – |
| on-line self management intervention with email reinforcement | Experimental | Behavioral: Internet Diabetes Self-Management Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have internet access and email address
- Live in the United States
- 18 years of age or older Exclusion Criteria:- Previous participation in similar online or community-based self-management program
- Active treatment for cancer
- Pregnant
Key exclusion criteria (0 listed)
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 Diabetes Self-Management Program | Behavioural | on-line self management intervention, on-line self management intervention with email reinforcement |
Primary outcome
HbA1c
Time frame: 6 and 12 months
3 secondary outcomes
Outcome Measure: Health-related quality of life
Time frame: 6 and 12 months
Outcome Measure: Health behaviors
Time frame: 6 and 12 months
Health care utilization
Time frame: 6 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 19 Apr 2013.
- Derived from this study: PubMed 19632975Case S, Jernigan V, Gardner A, Ritter P, Heaney CA, Lorig KR. Content and frequency of writing on diabetes bulletin boards: does race make a difference? J Med Internet Res. 2009 Jun 24;11(2):e22. doi: 10.2196/jmir.1153.
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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
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 Diabetes Self-Management Program in people with Diabetes Mellitus, Type 2, run by Stanford University 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 5 inclusion and 0 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 19 Apr 2013. 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?
HbA1c (time frame: 6 and 12 months). 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 NCT00185601, 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 19 Apr 2013.