Diabetes Mellitus, Type 2R2D2C2NCT01123239
Understanding and Improving Diabetes Care for Ethnic Minorities
A study testing Coached Care and Standard Diabetes Education in people with Diabetes Mellitus, Type 2, run by University of California, Irvine at 3 sites in United States.
Trial summary
In this study, we are testing the effectiveness of an intervention known as "Coached Care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Coached Care and Standard Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to Mar 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 2 diabetes
- At least one Hemoglobin A1c value greater than 7.5% in the year prior to recruitment.
Who cannot join
- Age above 80 years
- patients with dementia or other serious mental health problems that would prevent them from participating in the intervention.
- patients with other serious medical problems that would prevent them from participating in the intervention.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mary and Dick Allen Diabetes Center at Hoag Hospital
Newport Beach, California, 92663
University of California Irvine Medical Center
Orange, California, 92868
Westminster Medical Center
Westminster, California, 92683
About this study
Official title: Reducing Racial Disparities in Diabetes Care - The Coached Care Study
In this study, we are testing the effectiveness of an intervention known as "Coached Care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. The intervention involves training members of minority communities who have diabetes to be "coaches", teaching minority patients the skills needed to participate effectively in care during office visits, as they present for those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing participation skills before and between their routine office visits.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Coached Care, Standard Diabetes Education
- Keywords
- Healthcare Disparities
- 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.
Coached CareBehavioural
Coached Care pairs patients with linguistically and ethnically matched peer "coaches", who themselves have diabetes, and have been trained to meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making. Using a decision tree algorithm, they help patients identify relevant questions about symptoms, barriers to self-management and treatment options to discuss with doctor. They encourage mutual decision-making about tailoring the patient's medication regimen, diet and physical activities and work with the patients to overcome barriers to communication with their doctor. After the medical visit, the coach and patient review any treatment decisions and goals for self-care.
Standard Diabetes EducationBehavioural
Patients randomized to the control group will receive 20 minutes of standardized diabetes education delivered by staff research assistants. Education materials have been adapted from materials developed by the American Diabetes Association. The content of these materials includes information about the causes and complications of diabetes, as well as ways to reduce complication risks. Patients in the control arm will receive 20 minutes of standardized diabetes education before each visit
| Study group | Role | What they receive |
|---|---|---|
| Coached Care | Experimental | Coached Care pairs patients with linguistically and ethnically matched peer "coaches" who have been trained to promote patient participation in the medical visit. The coaches, who themselves have diabetes, meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making. Receives: Behavioral: Coached Care |
| Standard Diabetes Education | Active comparator | Patients receive one-on-one diabetes education sessions before each medical visit. These sessions are purely informational, and do not include the specific patient activation components of the coached care intervention. Receives: Behavioral: Standard Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
A laboratory measure of blood sugar control
Measured: 1 year and 2 year follow-up
Secondary outcomes (1)
Health-related quality of life
Patient reported general and diabetes-specific measures of quality of life, including SF-36, diabetes burden and others.
Measured: 1 year and 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJan 2006
- Primary completionMar 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 California, IrvineThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheldon Greenfield, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123239
- Sponsor's protocol ID
- HS# 2004-4025
- Other IDs
- R18DK069846, K01DK078939
- Acronym
- R2D2C2
- Status last verified
- May 2015
- First submitted
- 12 May 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malik S, Billimek J, Greenfield S, Sorkin DH, Ngo-Metzger Q, Kaplan SH. Patient complexity and risk factor control among multimorbid patients with type 2 diabetes: results from the R2D2C2 study. Med Care. 2013 Feb;51(2):180-5. doi: 10.1097/MLR.0b013e318273119b.
PubMed 23047130Sorkin DH, Ngo-Metzger Q, Billimek J, August KJ, Greenfield S, Kaplan SH. Underdiagnosed and undertreated depression among racially/ethnically diverse patients with type 2 diabetes. Diabetes Care. 2011 Mar;34(3):598-600. doi: 10.2337/dc10-1825. Epub 2011 Jan 27.
PubMed 21273497
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Racial Disparities in Diabetes Care - The Coached Care Study
- ClinicalTrials.gov ID
- NCT01123239
- Acronym / sponsor ID
- R2D2C2 / HS# 2004-4025
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Healthcare Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 May 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.
In this study, we are testing the effectiveness of an intervention known as "Coached Care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. The intervention involves training members of minority communities who have diabetes to be "coaches", teaching minority patients the skills needed to participate effectively in care during office visits, as they present for those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing participation skills before and between their routine office visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coached Care | Experimental | Behavioral: Coached CareCoached Care pairs patients with linguistically and ethnically matched peer "coaches" who have been trained to promote patient participation in the medical visit. The coaches, who themselves have diabetes, meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making. |
| Standard Diabetes Education | Active comparator | Behavioral: Standard Diabetes EducationPatients receive one-on-one diabetes education sessions before each medical visit. These sessions are purely informational, and do not include the specific patient activation components of the coached care intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of type 2 diabetes
- At least one Hemoglobin A1c value greater than 7.5% in the year prior to recruitment.
Key exclusion criteria (3 listed)
- Age above 80 years
- patients with dementia or other serious mental health problems that would prevent them from participating in the intervention.
- patients with other serious medical problems that would prevent them from participating in the intervention.
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 |
|---|---|---|
| Coached CareCoached Care pairs patients with linguistically and ethnically matched peer "coaches", who themselves have diabetes, and have been trained to meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making. Using a decision tree algorithm, they help patients identify relevant questions about symptoms, barriers to self-management and treatment options to discuss with doctor. They encourage mutual decision-making about tailoring the patient's medication regimen, diet and physical activities and work with the patients to overcome barriers to communication with their doctor. After the medical visit, the coach and patient review any treatment decisions and goals for self-care. | Behavioural | Coached Care |
| Standard Diabetes EducationPatients randomized to the control group will receive 20 minutes of standardized diabetes education delivered by staff research assistants. Education materials have been adapted from materials developed by the American Diabetes Association. The content of these materials includes information about the causes and complications of diabetes, as well as ways to reduce complication risks. Patients in the control arm will receive 20 minutes of standardized diabetes education before each visit | Behavioural | Standard Diabetes Education |
Primary outcome
Hemoglobin A1c
Time frame: 1 year and 2 year follow-up
A laboratory measure of blood sugar control
1 secondary outcome
Health-related quality of life
Time frame: 1 year and 2 year follow-up
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 27 May 2015.
- Derived from this study: PubMed 23047130Malik S, Billimek J, Greenfield S, Sorkin DH, Ngo-Metzger Q, Kaplan SH. Patient complexity and risk factor control among multimorbid patients with type 2 diabetes: results from the R2D2C2 study. Med Care. 2013 Feb;51(2):180-5. doi: 10.1097/MLR.0b013e318273119b.
- Derived from this study: PubMed 21273497Sorkin DH, Ngo-Metzger Q, Billimek J, August KJ, Greenfield S, Kaplan SH. Underdiagnosed and undertreated depression among racially/ethnically diverse patients with type 2 diabetes. Diabetes Care. 2011 Mar;34(3):598-600. doi: 10.2337/dc10-1825. Epub 2011 Jan 27.
- Homepage for the Reducing Racial Disparities in Diabetes Coached Care Study at UCILink provided by the sponsor.
Related trials for Diabetes Mellitus, Type 2
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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coached Care and Standard Diabetes Education in people with Diabetes Mellitus, Type 2, run by University of California, Irvine at 3 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 3 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Hemoglobin A1c (time frame: 1 year and 2 year follow-up). 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 NCT01123239, which also lists 2 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 27 May 2015.