Diabetes Mellitus Type 2NCT00403091
Internet Intervention to Improve Rural Diabetes Care
A study testing Internet Intervention in people with Diabetes Mellitus Type 2, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
Rural Diabetes Online Care (RDOC) will develop an Internet-based intervention for rural primary care physicians, focusing on improving care for adult patients with diabetes. The intervention, drawing upon the principles of quality improvement and providing tools for system-based changes in practice, is designed for… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Internet Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2005to Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Rural Primary Care Physicians
Who cannot join
- Non-rural non-primary care physicians
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Alabama
Tuscaloosa, Alabama, 35487
About this study
Rural Diabetes Online Care (RDOC) will develop an Internet-based intervention for rural primary care physicians, focusing on improving care for adult patients with diabetes. The intervention, drawing upon the principles of quality improvement and providing tools for system-based changes in practice, is designed for the rural practice, where resources are constrained.
Read the detailed description
This 4-year randomized trial of an Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.
Objectives. (1) Assess barriers to implementation of diabetes guidelines and identify solutions through focus groups and case-based vignette surveys; (2) Develop and implement an interactive Internet intervention including individualized physician performance feedback; (3) Evaluate the intervention in a randomized controlled trial; and (4) Examine the sustainability of improved guideline adherence once feedback ceases.
Methods. In partnership with the University of Alabama rural medicine program, we will randomize 200 rural physician offices to an intervention or comparison arm. Our 18-month intervention, customized to the individual physician in real-time, consists of Internet learning modules with case-based education, performance feedback, and benchmarks. The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources. Nurse practitioners and physician assistants from the offices of study physicians may also participate in the Internet modules. Outcomes will be based on previously developed and validated quality measures for diabetes. The intervention will cover screening, diagnosis, treatment, and prevention. Performance feedback will include 10-15 charts per intervention physician. The main analysis, conducted at the physician level, will compare differential improvement in guideline adherence between the study arms. Ancillary analyses will examine the effects of physician characteristics, other providers in the office, and patient characteristics (e.g., comorbidities, ethnicity, gender, age, and socioeconomic status). Multivariable techniques will adjust for repeated measures, clustering of patients within physicians, and multiple providers within a single office.
Study Population. RDOC will enroll 200 physicians from rural Alabama, Mississippi, Georgia, Tennessee, Florida, Arkansas, Kentucky, North Carolina, South Carolina, Missouri, and West Virginia. Participating physicians will be randomized to receive the intervention or to a comparison group, which will receive traditional, text-based continuing medical education (CME). Each participating physician will allow two rounds of medical record abstraction to be conducted in his/her office. Results from the medical record review: (1) be used in the intervention to provide physicians with personal performance feedback and (2) used to examine change in performance for the intervention and comparison physicians as an evaluation of the entire study.
Significance. This study offers a technologically advanced, theory-grounded intervention for improving care of a high-risk, underserved population. With expertise in translating research into practice, rural medicine, behavioral medicine, health informatics, and clinical diabetes, our multidisciplinary team has a proven record of collaboration. This project will produce an evidence-based and replicable intervention that can be sustained in the "real world," and easily modified for other diseases. This project is substantially improved after making important changes recommended in the second review.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Internet Intervention, Control
- Keywords
- Diabetes mellitus, Internet, Education, Professional, Quality Indicators, Health Care, Quality of Health Care, Hypertension, Hyperlipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet InterventionBehavioural
Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.
ControlBehavioural
The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Internet Intervention |
| Control | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
Measured: January 2005-present
Blood Pressure
Measured: January 2005-present
Lipids
Measured: January 2005-present
Secondary outcomes (5)
Eye screening
Measured: January 2005-present
Foot exam
Measured: January 2005-present
Kidney disease monitored
Measured: January 2005-present
Dietary or exercise advice
Measured: January 2005-present
Smoking cessation advice
Measured: January 2005-present
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startApr 2005
- Primary completionApr 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Alabama at BirminghamThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Jeroan J Allison, MD, MS Epi, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403091
- Sponsor's protocol ID
- X050111012
- Other IDs
- R18DK065001
- Status last verified
- Aug 2010
- First submitted
- 21 Nov 2006
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Safford MM, Allison JJ, Kiefe CI. Patient complexity: more than comorbidity. the vector model of complexity. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):382-90. doi: 10.1007/s11606-007-0307-0.
PubMed 18026806Safford MM, Shewchuk R, Qu H, Williams JH, Estrada CA, Ovalle F, Allison JJ. Reasons for not intensifying medications: differentiating "clinical inertia" from appropriate care. J Gen Intern Med. 2007 Dec;22(12):1648-55. doi: 10.1007/s11606-007-0433-8. Epub 2007 Oct 24.
PubMed 17957346Foster PP, Williams JH, Estrada CA, Higginbotham JC, Voltz ML, Safford MM, Allison J. Recruitment of rural physicians in a diabetes internet intervention study: overcoming challenges and barriers. J Natl Med Assoc. 2010 Feb;102(2):101-7. doi: 10.1016/s0027-9684(15)30497-1.
PubMed 20191922Billue KL, Safford MM, Salanitro AH, Houston TK, Curry W, Kim Y, Allison JJ, Estrada CA. Medication intensification in diabetes in rural primary care: a cluster-randomised effectiveness trial. BMJ Open. 2012 Sep 17;2(5):e000959. doi: 10.1136/bmjopen-2012-000959. Print 2012.
PubMed 22991217
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Intervention to Improve Rural Diabetes Care
- ClinicalTrials.gov ID
- NCT00403091
- Acronym / sponsor ID
- X050111012
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes mellitus, Internet, Education, Professional, Quality Indicators, Health Care, Quality of Health Care, Hypertension, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Nov 2006 (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.
Rural Diabetes Online Care (RDOC) will develop an Internet-based intervention for rural primary care physicians, focusing on improving care for adult patients with diabetes. The intervention, drawing upon the principles of quality improvement and providing tools for system-based changes in practice, is designed for the rural practice, where resources are constrained.
Detailed description
This 4-year randomized trial of an Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.
Objectives. (1) Assess barriers to implementation of diabetes guidelines and identify solutions through focus groups and case-based vignette surveys; (2) Develop and implement an interactive Internet intervention including individualized physician performance feedback; (3) Evaluate the intervention in a randomized controlled trial; and (4) Examine the sustainability of improved guideline adherence once feedback ceases.
Methods. In partnership with the University of Alabama rural medicine program, we will randomize 200 rural physician offices to an intervention or comparison arm. Our 18-month intervention, customized to the individual physician in real-time, consists of Internet learning modules with case-based education, performance feedback, and benchmarks. The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources. Nurse practitioners and physician assistants from the offices of study physicians may also participate in the Internet modules. Outcomes will be based on previously developed and validated quality measures for diabetes. The intervention will cover screening, diagnosis, treatment, and prevention. Performance feedback will include 10-15 charts per intervention physician. The main analysis, conducted at the physician level, will compare differential improvement in guideline adherence between the study arms. Ancillary analyses will examine the effects of physician characteristics, other providers in the office, and patient characteristics (e.g., comorbidities, ethnicity, gender, age, and socioeconomic status). Multivariable techniques will adjust for repeated measures, clustering of patients within physicians, and multiple providers within a single office.
Study Population. RDOC will enroll 200 physicians from rural Alabama, Mississippi, Georgia, Tennessee, Florida, Arkansas, Kentucky, North Carolina, South Carolina, Missouri, and West Virginia. Participating physicians will be randomized to receive the intervention or to a comparison group, which will receive traditional, text-based continuing medical education (CME). Each participating physician will allow two rounds of medical record abstraction to be conducted in his/her office. Results from the medical record review: (1) be used in the intervention to provide physicians with personal performance feedback and (2) used to examine change in performance for the intervention and comparison physicians as an evaluation of the entire study.
Significance. This study offers a technologically advanced, theory-grounded intervention for improving care of a high-risk, underserved population. With expertise in translating research into practice, rural medicine, behavioral medicine, health informatics, and clinical diabetes, our multidisciplinary team has a proven record of collaboration. This project will produce an evidence-based and replicable intervention that can be sustained in the "real world," and easily modified for other diseases. This project is substantially improved after making important changes recommended in the second review.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Internet Intervention |
| Control | Active comparator | Behavioral: Control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Rural Primary Care Physicians
Key exclusion criteria (1 listed)
- Non-rural non-primary care physicians
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 InterventionInternet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes. | Behavioural | Intervention |
| ControlThe comparison group will receive a text-based, non-interactive Internet posting of publicly available resources. | Behavioural | Control |
Primary outcome
A1c
Time frame: January 2005-present
Blood Pressure
Time frame: January 2005-present
Lipids
Time frame: January 2005-present
5 secondary outcomes
Eye screening
Time frame: January 2005-present
Foot exam
Time frame: January 2005-present
Kidney disease monitored
Time frame: January 2005-present
Dietary or exercise advice
Time frame: January 2005-present
Smoking cessation advice
Time frame: January 2005-present
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 11 Aug 2010.
- Background: PubMed 18026806Safford MM, Allison JJ, Kiefe CI. Patient complexity: more than comorbidity. the vector model of complexity. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):382-90. doi: 10.1007/s11606-007-0307-0.
- Results publication: PubMed 17957346Safford MM, Shewchuk R, Qu H, Williams JH, Estrada CA, Ovalle F, Allison JJ. Reasons for not intensifying medications: differentiating "clinical inertia" from appropriate care. J Gen Intern Med. 2007 Dec;22(12):1648-55. doi: 10.1007/s11606-007-0433-8. Epub 2007 Oct 24.
- Results publication: PubMed 20191922Foster PP, Williams JH, Estrada CA, Higginbotham JC, Voltz ML, Safford MM, Allison J. Recruitment of rural physicians in a diabetes internet intervention study: overcoming challenges and barriers. J Natl Med Assoc. 2010 Feb;102(2):101-7. doi: 10.1016/s0027-9684(15)30497-1.
- Derived from this study: PubMed 22991217Billue KL, Safford MM, Salanitro AH, Houston TK, Curry W, Kim Y, Allison JJ, Estrada CA. Medication intensification in diabetes in rural primary care: a cluster-randomised effectiveness trial. BMJ Open. 2012 Sep 17;2(5):e000959. doi: 10.1136/bmjopen-2012-000959. Print 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.
Jeroan J Allison, MD, MS Epi principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Intervention in people with Diabetes Mellitus Type 2, run by University of Alabama at Birmingham at 2 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?
The sponsor lists 1 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 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
A1c (time frame: January 2005-present). The study lists 3 primary outcomes in all. 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 NCT00403091, which also lists 4 linked publications.
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 11 Aug 2010.