Diabetes MellitusNCT01087073
Improving Diabetes Care and Outcomes on the South Side of Chicago
A study testing Patient Activation, Provider Training and Quality Improvement in people with Diabetes Mellitus, run by University of Chicago at 6 sites in United States.
Trial summary
The Improving Diabetes Care and Outcomes project aims to reduce diabetes disparities and engages patients, providers, clinics, and community collaborators to improve the health care and outcomes of African-Americans on the South Side of Chicago. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Patient Activation, Provider Training and Quality Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,209 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2009to 9 Nov 2016
- 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
- Patients must have a diabetes diagnosis (ICD-9 codes 250.X) and be age 18 years or older
- Patients must attend one of the participating health centers
Who cannot join
- Gestational diabetes patients
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
ACCESS Grand Boulevard Family Health Center
Chicago, Illinois, 60609
Friend Family Health Center
Chicago, Illinois, 60615
Chicago Family Health Center
Chicago, Illinois, 60617
Kovler Diabetes Center
Chicago, Illinois, 60637
University of Chicago, Primary Care Group
Chicago, Illinois, 60637
ACCESS Booker Family Health Center
Chicago, Illinois, 60653
About this study
The Improving Diabetes Care and Outcomes project aims to reduce diabetes disparities and engages patients, providers, clinics, and community collaborators to improve the health care and outcomes of African-Americans on the South Side of Chicago. Initiated in 2009, this project is a collaborative, community-based intervention that employs a multifaceted, integrated approach to address many of the root causes of health disparities. The short-term goal of this project is to improve clinic processes such as appointment scheduling and patient counseling through quality improvement efforts, as well as clinical outcomes including HbA1c, cholesterol and blood pressure in patients with diabetes through patient education. Long-term goals are to strengthen the network of community health centers, community-based organizations and academic medical centers, while increasing awareness of local diabetes disparities and empowering communities to combat this problem.
Read the detailed description
This multifactorial intervention contains four overlapping core components reflecting key elements of the Chronic Care Model.This model identifies patients, practice teams, the community, and health systems as four necessary elements in the successful management of chronic diseases such as diabetes. Six health centers (two academic center clinics affiliated with the University of Chicago and four FQHCs) are part of the intervention. Researchers at the University of Chicago received grant funding from the Merck Company Foundation's Alliance to Reduce Disparities in Diabetes and the National Institutes of Health to implement and evaluate the intervention.
The research and implementation team includes faculty and staff members with expertise in quality improvement, behavioral change, community outreach, patient education, and research methods.
The intervention has four main components:
- Patient Activation: We hold culturally tailored, 10-week patient education classes that combine culturally tailored patient education with training in shared decision-making skills to empower patients to be proactive in their diabetes self-management.
- Provider Training: We provide educational workshops for provider, clinical, and non-clinical staff at our six intervention clinics on patient-centered communication, cultural competency, behavior change counseling, and shared decision making.
- Quality Improvement: Our team facilitates quality improvement (QI) programs redesigning clinic operations to improve care for diabetes patients. QI initiatives have included instituting group visits, patient medication cards, peer support groups, flow sheets, nurse case management, and patient registries. New initiatives include improving access and tracking of specialists visits through EMR, employing community health workers/patient navigators, coordinating care, and implementing other team-based care initiatives. We also perform a cost/benefits analysis of intervention implementation from the business case perspective of the outpatient clinics and determine the major barriers and solutions to successfully implement and sustain the project at each location.
- Community Outreach: We collaborate with existing community resources to create sustainable collaborations that support diabetes patients outside of the health care system and promote nutrition and a healthy lifestyle. We collaborate with grocery stores, food pantries, the Chicago Park District, farmers markets, media outlets, grocery stores and other community-based organizations.
- Conditions
- Diabetes Mellitus
- Being tested
- Patient Activation, Provider Training, Quality Improvement, Community Outreach
- Keywords
- Healthcare Disparities, Health Care Quality Improvement, Shared Decision-Making, Patient Education, Patient Activation, Community Outreach, Provider Training
- Medical subject headings
- Diabetes Mellitus, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient ActivationBehavioural
Also called Patient Education
Culturally tailored patient activation training classes providing education and communication strategies to empower patients to be proactive in their diabetes self-management behavior. Participants attend a 10 week interactive class. Diabetes support groups after the completion of these classes help patient maintain self-management and adherence to healthy behaviors.
Provider TrainingBehavioural
Provider patient-centered communication training focuses on cultural competency and communication skills training to aid in shared decision-making and tailoring treatment recommendations to the patient's cultural preferences and readiness. Providers attend 4 1-hour monthly modules and one booster workshop 3 months post-class.
Quality ImprovementBehavioural
Participating clinics participate in quality improvement (QI) programs which aim to redesign clinic operations to improve care for diabetes patients. QI initiatives have included instituting group visits, patient medication cards, peer support groups, flow sheets, nurse case management, and patient registries. New initiatives include improving access and tracking of specialists visits, employing community health workers/patient navigators, coordinating care, and implementing other team-based care initiatives. Provider and clinical staff members from all six project clinics attend collaborative quarterly QI sessions with project staff to discuss improvements in QI efforts, share QI methods among clinic teams, and provide brief training sessions.
Community OutreachBehavioural
Also called Community Partnerships
The project collaborates with many community based organizations and resources to reach out to communities at high risk for diabetes on the South Side of Chicago and facilitate diabetes education, particularly in the area of nutrition and physical activity. We provide monthly health education events, nutrition tours, and frequently participate in community-based health fairs and health promotion events. We also work to promote nutrition through the Food Rx program, which utilizes a prescription to link patients at our clinics with nutrition resources on the South Side of Chicago through a coupon that gives discounts towards healthy purchases at participating stores, and have initiated a 10-week fitness program to promote physical activity among minority patients with diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Patient Activation | Experimental | Patient knowledge in diabetes self-management behaviors and clinical measures (HbA1c, LDL, HDL, BMI, BP) are tracked at baseline, 10-weeks (post-program), 3 months (post-program) and 6 months (post-program). Receives: Behavioral: Patient Activation |
| Provider Training Evaluation | Experimental | Pre-post surveys are conducted at each training session to assess overall satisfaction with the curriculum, knowledge of SDM, and understanding of techniques to promote its use in the healthcare setting. Receives: Behavioral: Provider Training |
| Quality Improvement Evaluation | Experimental | We measure quality improvement efforts through biannual staff experience surveys and one-on-one provider and clinic staff interviews. Receives: Behavioral: Quality Improvement |
| Community Outreach Evaluation | Experimental | Pre-post surveys will be disseminated at nutrition tours (Save-A-Lot, Walgreens, 61st Street Farmers Market) to assess change in knowledge of healthy eating behaviors and proper nutrition. Surveys will also assess participant satisfaction of the tours.
Interviews will also be performed with community stakeholders to assess the costs/benefits of the collaboration and overall feedback on involvement. Receives: Behavioral: Community Outreach |
| Global Evaluation of the Intervention | No intervention | A chart review will be performed in order to evaluate our intervention to improve diabetes processes of care and clinical outcomes among our target population. Chart abstractions will be performed on medical records obtained from our six intervention clinics. In addition, chart abstractions from two University of Illinois at Chicago clinics and three FQHCs located on the West Side of Chicago will serve as control data.100 charts will be randomly selected from each clinic per year of the intervention. The chart review will contain charts from adult diabetes patients over a seven year period that matches the duration of the Improving Diabetes project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older). Will also be collected from patients in the patient activation component.
Measured: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
Blood pressure
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older). Will also be collected from patients in the patient activation component.
Measured: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
Lipids (HDL, LDL, total cholesterol, triglycerides)
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older). Will also be collected from patients in the patient activation component.
Measured: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
Secondary outcomes (1)
Processes of care
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older).
Annual Processes of Care:
At least 1 HbA1c, Lipid assessment, Microalbumin assessment, ACE inhibitor or ARB prescribed, Aspirin prescribed, Dental referral, Eye exam or referral, Foot exam or referral, Influenza vaccination, Home glucose monitoring, Dietary counseling or referral, Exercise counseling, Diabetes education
Measured: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study start1 Jan 2009
- Primary completion9 Nov 2016
- Study completion9 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Marshall Chin, MD, MPH, Principal investigator, University of ChicagoMonica Peek, MD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087073
- Sponsor's protocol ID
- 16867B (TRACS ID: 40596)
- Other IDs
- R18DK083946, P30DK092949, Alliance to Reduce Disparities
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2010
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Peek ME, Ferguson M, Bergeron N, Maltby D, Chin MH. Integrated community-healthcare diabetes interventions to reduce disparities. Curr Diab Rep. 2014 Mar;14(3):467. doi: 10.1007/s11892-013-0467-8.
PubMed 24464339Wilkes AE, Bordenave K, Vinci L, Peek ME. Addressing diabetes racial and ethnic disparities: lessons learned from quality improvement collaboratives. Diabetes Manag (Lond). 2011 Nov;1(6):653-660. doi: 10.2217/dmt.11.48.
PubMed 22563350Nundy S, Lu CY, Hogan P, Mishra A, Peek ME. Using Patient-Generated Health Data From Mobile Technologies for Diabetes Self-Management Support: Provider Perspectives From an Academic Medical Center. J Diabetes Sci Technol. 2014 Jan;8(1):74-82. doi: 10.1177/1932296813511727. Epub 2014 Jan 1.
PubMed 24876541Nundy S, Dick JJ, Chou CH, Nocon RS, Chin MH, Peek ME. Mobile phone diabetes project led to improved glycemic control and net savings for Chicago plan participants. Health Aff (Millwood). 2014 Feb;33(2):265-72. doi: 10.1377/hlthaff.2013.0589.
PubMed 24493770Nundy S, Dick JJ, Solomon MC, Peek ME. Developing a behavioral model for mobile phone-based diabetes interventions. Patient Educ Couns. 2013 Jan;90(1):125-32. doi: 10.1016/j.pec.2012.09.008. Epub 2012 Oct 10.
PubMed 23063349Nundy S, Dick JJ, Goddu AP, Hogan P, Lu CY, Solomon MC, Bussie A, Chin MH, Peek ME. Using mobile health to support the chronic care model: developing an institutional initiative. Int J Telemed Appl. 2012;2012:871925. doi: 10.1155/2012/871925. Epub 2012 Dec 5.
PubMed 23304135Peek ME, Gorawara-Bhat R, Quinn MT, Odoms-Young A, Wilson SC, Chin MH. Patient trust in physicians and shared decision-making among African-Americans with diabetes. Health Commun. 2013;28(6):616-23. doi: 10.1080/10410236.2012.710873. Epub 2012 Oct 10.
PubMed 23050731Peek ME, Tang H, Cargill A, Chin MH. Are there racial differences in patients' shared decision-making preferences and behaviors among patients with diabetes? Med Decis Making. 2011 May-Jun;31(3):422-31. doi: 10.1177/0272989X10384739. Epub 2010 Dec 2.
PubMed 21127318Peek ME, Wagner J, Tang H, Baker DC, Chin MH. Self-reported racial discrimination in health care and diabetes outcomes. Med Care. 2011 Jul;49(7):618-25. doi: 10.1097/MLR.0b013e318215d925.
PubMed 21478770Peek ME, Odoms-Young A, Quinn MT, Gorawara-Bhat R, Wilson SC, Chin MH. Race and shared decision-making: perspectives of African-Americans with diabetes. Soc Sci Med. 2010 Jul;71(1):1-9. doi: 10.1016/j.socscimed.2010.03.014. Epub 2010 Mar 24.
PubMed 20409625Peek ME, Odoms-Young A, Quinn MT, Gorawara-Bhat R, Wilson SC, Chin MH. Racism in healthcare: Its relationship to shared decision-making and health disparities: a response to Bradby. Soc Sci Med. 2010 Jul;71(1):13-7. doi: 10.1016/j.socscimed.2010.03.018. Epub 2010 Mar 24. No abstract available.
PubMed 20403654Chin MH, Walters AE, Cook SC, Huang ES. Interventions to reduce racial and ethnic disparities in health care. Med Care Res Rev. 2007 Oct;64(5 Suppl):7S-28S. doi: 10.1177/1077558707305413.
PubMed 17881624Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
PubMed 17881626Chin MH. Quality improvement implementation and disparities: the case of the health disparities collaboratives. Med Care. 2010 Aug;48(8):668-75. doi: 10.1097/MLR.0b013e3181e3585c.
PubMed 20613665Raffel KE, Goddu AP, Peek ME. "I Kept Coming for the Love": Enhancing the Retention of Urban African Americans in Diabetes Education. Diabetes Educ. 2014 May;40(3):351-360. doi: 10.1177/0145721714522861. Epub 2014 Feb 13.
PubMed 24525568
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Care and Outcomes on the South Side of Chicago
- ClinicalTrials.gov ID
- NCT01087073
- Acronym / sponsor ID
- 16867B (TRACS ID: 40596)
- Conditions
- Diabetes Mellitus
- Keywords
- Healthcare Disparities, Health Care Quality Improvement, Shared Decision-Making, Patient Education, Patient Activation, Community Outreach, Provider Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,209 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 15 Mar 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.
The Improving Diabetes Care and Outcomes project aims to reduce diabetes disparities and engages patients, providers, clinics, and community collaborators to improve the health care and outcomes of African-Americans on the South Side of Chicago. Initiated in 2009, this project is a collaborative, community-based intervention that employs a multifaceted, integrated approach to address many of the root causes of health disparities. The short-term goal of this project is to improve clinic processes such as appointment scheduling and patient counseling through quality improvement efforts, as well as clinical outcomes including HbA1c, cholesterol and blood pressure in patients with diabetes through patient education. Long-term goals are to strengthen the network of community health centers, community-based organizations and academic medical centers, while increasing awareness of local diabetes disparities and empowering communities to combat this problem.
Detailed description
This multifactorial intervention contains four overlapping core components reflecting key elements of the Chronic Care Model.This model identifies patients, practice teams, the community, and health systems as four necessary elements in the successful management of chronic diseases such as diabetes. Six health centers (two academic center clinics affiliated with the University of Chicago and four FQHCs) are part of the intervention. Researchers at the University of Chicago received grant funding from the Merck Company Foundation's Alliance to Reduce Disparities in Diabetes and the National Institutes of Health to implement and evaluate the intervention.
The research and implementation team includes faculty and staff members with expertise in quality improvement, behavioral change, community outreach, patient education, and research methods.
The intervention has four main components:
- Patient Activation: We hold culturally tailored, 10-week patient education classes that combine culturally tailored patient education with training in shared decision-making skills to empower patients to be proactive in their diabetes self-management.
- Provider Training: We provide educational workshops for provider, clinical, and non-clinical staff at our six intervention clinics on patient-centered communication, cultural competency, behavior change counseling, and shared decision making.
- Quality Improvement: Our team facilitates quality improvement (QI) programs redesigning clinic operations to improve care for diabetes patients. QI initiatives have included instituting group visits, patient medication cards, peer support groups, flow sheets, nurse case management, and patient registries. New initiatives include improving access and tracking of specialists visits through EMR, employing community health workers/patient navigators, coordinating care, and implementing other team-based care initiatives. We also perform a cost/benefits analysis of intervention implementation from the business case perspective of the outpatient clinics and determine the major barriers and solutions to successfully implement and sustain the project at each location.
- Community Outreach: We collaborate with existing community resources to create sustainable collaborations that support diabetes patients outside of the health care system and promote nutrition and a healthy lifestyle. We collaborate with grocery stores, food pantries, the Chicago Park District, farmers markets, media outlets, grocery stores and other community-based organizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patient Activation | Experimental | Behavioral: Patient ActivationPatient knowledge in diabetes self-management behaviors and clinical measures (HbA1c, LDL, HDL, BMI, BP) are tracked at baseline, 10-weeks (post-program), 3 months (post-program) and 6 months (post-program). |
| Provider Training Evaluation | Experimental | Behavioral: Provider TrainingPre-post surveys are conducted at each training session to assess overall satisfaction with the curriculum, knowledge of SDM, and understanding of techniques to promote its use in the healthcare setting. |
| Quality Improvement Evaluation | Experimental | Behavioral: Quality ImprovementWe measure quality improvement efforts through biannual staff experience surveys and one-on-one provider and clinic staff interviews. |
| Community Outreach Evaluation | Experimental | Behavioral: Community OutreachPre-post surveys will be disseminated at nutrition tours (Save-A-Lot, Walgreens, 61st Street Farmers Market) to assess change in knowledge of healthy eating behaviors and proper nutrition. Surveys will also assess participant satisfaction of the tours. Interviews will also be performed with community stakeholders to assess the costs/benefits of the collaboration and overall feedback on involvement. |
| Global Evaluation of the Intervention | No intervention | –A chart review will be performed in order to evaluate our intervention to improve diabetes processes of care and clinical outcomes among our target population. Chart abstractions will be performed on medical records obtained from our six intervention clinics. In addition, chart abstractions from two University of Illinois at Chicago clinics and three FQHCs located on the West Side of Chicago will serve as control data.100 charts will be randomly selected from each clinic per year of the intervention. The chart review will contain charts from adult diabetes patients over a seven year period that matches the duration of the Improving Diabetes project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have a diabetes diagnosis (ICD-9 codes 250.X) and be age 18 years or older
- Patients must attend one of the participating health centers
Key exclusion criteria (1 listed)
- Gestational diabetes patients
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 |
|---|---|---|
| Patient ActivationAlso: Patient EducationCulturally tailored patient activation training classes providing education and communication strategies to empower patients to be proactive in their diabetes self-management behavior. Participants attend a 10 week interactive class. Diabetes support groups after the completion of these classes help patient maintain self-management and adherence to healthy behaviors. | Behavioural | Patient Activation |
| Provider TrainingProvider patient-centered communication training focuses on cultural competency and communication skills training to aid in shared decision-making and tailoring treatment recommendations to the patient's cultural preferences and readiness. Providers attend 4 1-hour monthly modules and one booster workshop 3 months post-class. | Behavioural | Provider Training Evaluation |
| Quality ImprovementParticipating clinics participate in quality improvement (QI) programs which aim to redesign clinic operations to improve care for diabetes patients. QI initiatives have included instituting group visits, patient medication cards, peer support groups, flow sheets, nurse case management, and patient registries. New initiatives include improving access and tracking of specialists visits, employing community health workers/patient navigators, coordinating care, and implementing other team-based care initiatives. Provider and clinical staff members from all six project clinics attend collaborative quarterly QI sessions with project staff to discuss improvements in QI efforts, share QI methods among clinic teams, and provide brief training sessions. | Behavioural | Quality Improvement Evaluation |
| Community OutreachAlso: Community PartnershipsThe project collaborates with many community based organizations and resources to reach out to communities at high risk for diabetes on the South Side of Chicago and facilitate diabetes education, particularly in the area of nutrition and physical activity. We provide monthly health education events, nutrition tours, and frequently participate in community-based health fairs and health promotion events. We also work to promote nutrition through the Food Rx program, which utilizes a prescription to link patients at our clinics with nutrition resources on the South Side of Chicago through a coupon that gives discounts towards healthy purchases at participating stores, and have initiated a 10-week fitness program to promote physical activity among minority patients with diabetes. | Behavioural | Community Outreach Evaluation |
Primary outcome
HbA1c
Time frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older). Will also be collected from patients in the patient activation component.
Blood pressure
Time frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older). Will also be collected from patients in the patient activation component.
Lipids (HDL, LDL, total cholesterol, triglycerides)
Time frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
Chart audit will be conducted on 100 randomly selected diabetes patients meeting the age inclusion criteria (age 18 years and older). Will also be collected from patients in the patient activation component.
1 secondary outcome
Processes of care
Time frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.
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 26 Apr 2023.
- Background: PubMed 24464339Peek ME, Ferguson M, Bergeron N, Maltby D, Chin MH. Integrated community-healthcare diabetes interventions to reduce disparities. Curr Diab Rep. 2014 Mar;14(3):467. doi: 10.1007/s11892-013-0467-8.
- Background: PubMed 22563350Wilkes AE, Bordenave K, Vinci L, Peek ME. Addressing diabetes racial and ethnic disparities: lessons learned from quality improvement collaboratives. Diabetes Manag (Lond). 2011 Nov;1(6):653-660. doi: 10.2217/dmt.11.48.
- Background: PubMed 24876541Nundy S, Lu CY, Hogan P, Mishra A, Peek ME. Using Patient-Generated Health Data From Mobile Technologies for Diabetes Self-Management Support: Provider Perspectives From an Academic Medical Center. J Diabetes Sci Technol. 2014 Jan;8(1):74-82. doi: 10.1177/1932296813511727. Epub 2014 Jan 1.
- Background: PubMed 24493770Nundy S, Dick JJ, Chou CH, Nocon RS, Chin MH, Peek ME. Mobile phone diabetes project led to improved glycemic control and net savings for Chicago plan participants. Health Aff (Millwood). 2014 Feb;33(2):265-72. doi: 10.1377/hlthaff.2013.0589.
- Background: PubMed 23063349Nundy S, Dick JJ, Solomon MC, Peek ME. Developing a behavioral model for mobile phone-based diabetes interventions. Patient Educ Couns. 2013 Jan;90(1):125-32. doi: 10.1016/j.pec.2012.09.008. Epub 2012 Oct 10.
- Background: PubMed 23304135Nundy S, Dick JJ, Goddu AP, Hogan P, Lu CY, Solomon MC, Bussie A, Chin MH, Peek ME. Using mobile health to support the chronic care model: developing an institutional initiative. Int J Telemed Appl. 2012;2012:871925. doi: 10.1155/2012/871925. Epub 2012 Dec 5.
- Background: PubMed 23050731Peek ME, Gorawara-Bhat R, Quinn MT, Odoms-Young A, Wilson SC, Chin MH. Patient trust in physicians and shared decision-making among African-Americans with diabetes. Health Commun. 2013;28(6):616-23. doi: 10.1080/10410236.2012.710873. Epub 2012 Oct 10.
- Background: PubMed 21127318Peek ME, Tang H, Cargill A, Chin MH. Are there racial differences in patients' shared decision-making preferences and behaviors among patients with diabetes? Med Decis Making. 2011 May-Jun;31(3):422-31. doi: 10.1177/0272989X10384739. Epub 2010 Dec 2.
- Background: PubMed 21478770Peek ME, Wagner J, Tang H, Baker DC, Chin MH. Self-reported racial discrimination in health care and diabetes outcomes. Med Care. 2011 Jul;49(7):618-25. doi: 10.1097/MLR.0b013e318215d925.
- Background: PubMed 20409625Peek ME, Odoms-Young A, Quinn MT, Gorawara-Bhat R, Wilson SC, Chin MH. Race and shared decision-making: perspectives of African-Americans with diabetes. Soc Sci Med. 2010 Jul;71(1):1-9. doi: 10.1016/j.socscimed.2010.03.014. Epub 2010 Mar 24.
- Background: PubMed 20403654Peek ME, Odoms-Young A, Quinn MT, Gorawara-Bhat R, Wilson SC, Chin MH. Racism in healthcare: Its relationship to shared decision-making and health disparities: a response to Bradby. Soc Sci Med. 2010 Jul;71(1):13-7. doi: 10.1016/j.socscimed.2010.03.018. Epub 2010 Mar 24. No abstract available.
- Background: PubMed 17881624Chin MH, Walters AE, Cook SC, Huang ES. Interventions to reduce racial and ethnic disparities in health care. Med Care Res Rev. 2007 Oct;64(5 Suppl):7S-28S. doi: 10.1177/1077558707305413.
- Improving Diabetes Care and Outcomes Project WebsiteLink provided by the sponsor.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Marshall Chin, MD, MPH principal investigator
University of Chicago
Monica Peek, MD, MPH principal investigator
University of Chicago
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Activation, Provider Training and Quality Improvement in people with Diabetes Mellitus, run by University of Chicago at 6 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 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
HbA1c (time frame: Baseline data will be collected at the end of 1st year; follow-up data will be collected from years 2-7.). 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 NCT01087073, which also lists 19 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 26 Apr 2023.