Temple, Texas 76504


Purpose:

To evaluate the effectiveness of two different diabetes self-management approaches (Personal Digital Assistant-based intervention & Chronic Disease Self-Management Program) to reduce health disparities in minority, rural residents, and other underserved populations with type 2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with T2DM will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes, which persist even when controlling for age, gender, obesity, and insurance status; 2) Patients with T2DM who reside in more rural areas will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes as compared to more urban counterparts, controlling for age, gender, race/ethnicity, obesity, and insurance status; 3) The introduction of CSDMP and HIT protocols will improve diabetes-related self management behaviors, reduce HBA1c values, and increase quality of life in persons with T2DM as compared to controls. A combined intervention approach will result in the greatest reductions; 4) Health improvements following the introduction of CDSMP, HIT or CDSMP/HIT protocols in persons with T2DM compared to controls will be more marked in racial/ethnic minority patients and those patients residing in rural areas; 5) The introduction of self-management interventions will be cost-effective in reducing HbA1c values over time, and associated health care utilization including overall reduction in ER and acute care hospital admissions; 6) Although there is little prior research in this area to guide specific hypotheses, we hypothesize that, overall, there will be no significant cost-effective differential in CDSMP as compared to HIT approaches, although the cost-effective ratio may be stronger in particular subpopulations. The combined approach will have higher costs, but is also anticipated to have a higher cost-benefit ratio for minority populations; 7) The majority of clinicians will be willing to let their patients enroll in the study and will reinforce intervention protocols; and 8) These interventions can be embedded into existing health care structures. At the end of the study, Scott and White will institutionalize cost-effective treatment protocols.


Study summary:

Despite concerted federal and state attempts to reduce health disparities over the past decades substantial disparities in reported rates of chronic disease for minorities still exist. In particular, African Americans and Hispanics experience higher rates of Type 2 diabetes (T2DM), and cardiovascular disease (CVD) than do other segments of the U.S. population. The objectives of this proposed research project are to test two different diabetes self-management (DSM) programs in a large multi-site health care organization in Central Texas that serves large populations of minority and rural residents, comparing outcomes in order to evaluate their efficacy for reducing health disparities. Our specific aims are to: 1) document the nature and magnitude of extant health disparities in diabetes treatment processes and outcomes; 2) evaluate different DSM intervention approaches on behavioral and clinical outcomes, with attention to differential effects by patient and environmental characteristics; 3) examine the cost-effectiveness of these different approaches to DSM education in minority and rural populations; and 4) explore the reach of our intervention efforts and the broader organizational impacts of DSM education, including feedback loops to clinicians and organizational receptivity to self-management approaches. Our study will employ four different activities: 1) an initial electronic chart review of 1300 records of adults; 2) a 2 by 2 open 24 month randomized clinical trial of behaviorally and technologically based DSM interventions with 400 adults age 21 and older who have type 2 diabetes (T2DM); 3) a cost-effectiveness analysis of the different treatment approaches; and 4) surveys of primary care providers and health care administrators. While our primary outcome will be reductions in hemoglobin A1c (HbA1c), our conceptual model includes clinical, behavioral, economic and organizational outcomes. We will also assess the extent to which our interventions reduce health disparities by examining differential treatment success. This study is innovative in its comparison of both behavioral and technological intervention approaches, its attention to the public health impact and cost-effectiveness of different intervention approaches, and its concern with organizational responses to intervention sustainability. A noteworthy significance will be the strengthening of the linkages between clinical and community treatment approaches and the identification of successful treatment strategies in different settings and populations.


Criteria:

Inclusion Criteria: - Patients with T2DM, including those who require insulin therapy, aged >18 years (eliminates the need to obtain assent for minors who are also dependent on their parents). - Last measured HbA1c value of > 7.5% (this study hopes to show an improvement in the control of patient's diabetes, and not focused on patients who already show evidence of good disease control). - Willingness and ability to attend one initial research visit and semi-annual routine follow-up visits over a 24-month period. The follow-up visits include height, weight, and blood pressure measurement and a survey. Surveys may be conducted by phone interview or mail when a follow-up visit can not be scheduled. - Ability to read, write, and speak English at least at a grade 8 level so as to be able to engage in self-monitoring and use the commercial diabetes management software program (Diabetes Pilot), which is available only in English. For those with lower-literacy, assistance in filling out forms and understanding required intervention protocols will be provided, and use of a "buddy" will be recommended. Exclusion Criteria: - Not willing to sign an informed consent or be randomized to any of the four treatment/control groups, (we want to minimize any upfront treatment biases, while adhering to human subject protocols). - Currently, documented severe alcoholism or drug abuse that is < 6 months ago (concerns that this problem is likely to significantly affect their ability and likelihood to comply with the study requirements over the course of the 24 months). - Female patients who are pregnant or planning to become pregnant within 12 months (in pregnancy, type 2 diabetes is managed in a completely different manner than in non-pregnant patients).


Study is Available At:


Original ID:

071304


NCT ID:

NCT01221090


Secondary ID:

P20MD002295


Study Acronym:

P20-P2


Brief Title:

Diabetes Self-Management Models to Reduce Health Disparities


Official Title:

Employing Diabetes Self-Management Models to Reduce Health Disparities in Texas


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Scott and White Hospital & Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

400


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Samuel N Forjuoh, MD MPH DrPH
Principal Investigator
Scott & White
Primary Contact:Dawn Begaye
254-771-7749
dbegaye@swmail.sw.org
Backup Contact:Janet W Helduser, MA
979-458-0148
jwhelduser@srph.tamhsc.edu

Study Dates

Start Date:January 2009
Completion Date:May 2012
Completion Type:Anticipated
Primary Completion Date:May 2012
Primary Completion Type:Anticipated
Verification Date:August 2010
Last Changed Date:October 13, 2010
First Received Date:October 13, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:HbA1c
Time Frame:12 months
Safety Issues:False
Description:Measured 6 monthly
Outcome Type:Secondary Outcome
Measure:BMI
Time Frame:12 months
Safety Issues:False
Description:Body mass index
Outcome Type:Secondary Outcome
Measure:Patient self-reported perceived health status
Time Frame:12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Diabetes-related behaviors
Time Frame:12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:QOL
Time Frame:12 months
Safety Issues:False
Description:Quality of life

Study Interventions

Intervention Type:Behavioral
Name:PDA
Description:Technological assistance
Arm Name:Personal Digital Assistant
Other Name:Personal digital assistant
Intervention Type:Behavioral
Name:CDSMP
Description:6-week classes
Arm Name:CDSMP
Other Name:Chronic disease self-management program
Intervention Type:Behavioral
Name:PDA/CDSMP
Description:Combined technology and education
Arm Name:PDA/CDSMP
Other Name:PDA + CDSMP

Study Arms

Study Arm Type:Active Comparator
Arm Name:PDA/CDSMP
Description:Combined intervention
Study Arm Type:Active Comparator
Arm Name:CDSMP
Description:6-week educational classes
Study Arm Type:Experimental
Arm Name:Personal Digital Assistant
Description:Personal digital assistance (technological)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Scott and White Hospital & Clinic
Agency Class:Other
Agency Type:Collaborator
Agency Name:Texas A&M University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Forjuoh SN, Huber C, Bolin JN, Patil SP, Gupta M, Helduser JW, Holleman S, Ory MG. Provision of counseling on diabetes self-management: Are there any age disparities? Patient Educ Couns. 2010 Sep 20; [Epub ahead of print]
PMID:20863646

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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