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| ID | Type | Description | Link |
|---|---|---|---|
| P20MD002295 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Texas A&M University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personal Digital Assistant | Experimental | Individuals in this arm were taught to use a diabetes self-care software, Diabetes Pilot™ (Digital Altitudes, Arlington Heights, IL), developed for PalmOS® (Palm, Sunnyvale, CA) which was loaded on to compatible PDAs, the Tungsten™ E2 handheld device. The Diabetes Pilot allowed participants to monitor their blood glucose, blood pressure, medication usage, physical activity, and dietary intake by tracking these measures in an electronic diary. |
|
| CDSMP | Active Comparator | 6-week, classroom-based program for diabetes self-management. The CDSMP, developed by Stanford University, equipped participants with the education and skill sets needed to take a more proactive approach in managing their chronic condition(s) and related symptoms. |
|
| PDA/CDSMP | Active Comparator | Combined intervention |
|
| Control | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDA | Behavioral | Technological assistance |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Body mass index | 12 months |
| Patient Self-reported Perceived Health Status | 12 months | |
| Diabetes-related Behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel N Forjuoh, MD MPH DrPH | Scott & White | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scott & White Clinic | Temple | Texas | 76504 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23013155 | Background | Vuong AM, Huber JC Jr, Bolin JN, Ory MG, Moudouni DM, Helduser J, Begaye D, Bonner TJ, Forjuoh SN. Factors affecting acceptability and usability of technological approaches to diabetes self-management: a case study. Diabetes Technol Ther. 2012 Dec;14(12):1178-82. doi: 10.1089/dia.2012.0139. Epub 2012 Sep 26. | |
| 23288286 | Background | Appiah B, Hong Y, Ory MG, Helduser JW, Begaye D, Bolin JN, Forjuoh SN. Challenges and opportunities for implementing diabetes self-management guidelines. J Am Board Fam Med. 2013 Jan-Feb;26(1):90-2. doi: 10.3122/jabfm.2013.01.120177. |
| Label | URL |
|---|---|
| Division of Research, Department of Family \& Community Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CDSMP | 6-week educational classes CDSMP : 6-week classes |
| FG001 | Personal Digital Assistant (PDA) | Personal digital assistance (technological) PDA : Technological assistance |
| FG002 | PDA/CDSMP | Combined intervention PDA/CDSMP : Combined technology and education |
| FG003 | Control | Usual Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CDSMP | 6-week educational classes CDSMP : 6-week classes |
| BG001 | Personal Digital Assistant (PDA) | Personal digital assistance (technological) PDA : Technological assistance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c | Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation. | A participant was included in the analysis if he/she had a HbA1c value collected. A longitudinal analysis was performed, with participants contributing one or more HbA1c values to the model. As such, all participants had at least one HbA1c value and were therefore included in the model. | Posted | Mean | Standard Deviation | percentage of gycosylated HbA1c | 12 months | HbA1c | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDSMP | 6-week educational classes CDSMP : 6-week classes |
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Differential dropout across interventions. Failure to obtain 50% minority and 50% non-minority participants, preventing further analyses regarding race/ethnicity differences in outcome. Could only provide information in an exploratory manner.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samuel N. Forjuoh | Scott & White Hospital | (254) 771-7695 | SFORJUOH@sw.org |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| CDSMP | Behavioral | 6-week classes |
|
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| PDA/CDSMP | Behavioral | Combined technology and education |
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Participants were asked the number of days in the past 7 which they participated in various diabetes self-care activities on diet, exercise, home blood glucose monitoring, and foot care. |
| 12 months |
| Quality of Life (QOL) | Participants where asked the number of days in the past 30 days in which their physical (phys) and/or mental was not good, and whether their usual activity was affected by their physical/mental health. | 12 months |
| 20863646 | Result | 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. 2011 Nov;85(2):133-9. doi: 10.1016/j.pec.2010.08.004. Epub 2010 Sep 21. |
| 21104573 | Result | Forjuoh SN, Bolin JN, Gupta M, Huber C, Helduser JW, Holleman S, Robertson A, Ory MG. Disparities in diabetes management by race or ethnicity in a primary care clinic in central Texas. Tex Med. 2010 Nov 1;106(11):e1. |
| 24468198 | Derived | Adepoju OE, Bolin JN, Phillips CD, Zhao H, Ohsfeldt RL, McMaughan DK, Helduser JW, Forjuoh SN. Effects of diabetes self-management programs on time-to-hospitalization among patients with type 2 diabetes: a survival analysis model. Patient Educ Couns. 2014 Apr;95(1):111-7. doi: 10.1016/j.pec.2014.01.001. Epub 2014 Jan 13. |
| 24450992 | Derived | Forjuoh SN, Bolin JN, Huber JC Jr, Vuong AM, Adepoju OE, Helduser JW, Begaye DS, Robertson A, Moudouni DM, Bonner TJ, McLeroy KR, Ory MG. Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial. BMC Public Health. 2014 Jan 23;14:71. doi: 10.1186/1471-2458-14-71. |
| 24152055 | Derived | Adepoju OE, Bolin JN, Ohsfeldt RL, Phillips CD, Zhao H, Ory MG, Forjuoh SN. Can chronic disease management programs for patients with type 2 diabetes reduce productivity-related indirect costs of the disease? Evidence from a randomized controlled trial. Popul Health Manag. 2014 Apr;17(2):112-20. doi: 10.1089/pop.2013.0029. Epub 2013 Oct 23. |
| Withdrawal by Subject |
|
| BG002 | PDA/CDSMP | Combined intervention PDA/CDSMP : Combined technology and education |
| BG003 | Control | Usual Care |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Minority | Individuals categorized as minority were those who self-reported as either African American or Hispanic | Number | Participants |
|
| Race-Ethnicity | Number | Participants |
|
| Education | Number | Participants |
|
| Income | Number | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm/Hg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mm/Hg |
|
| HbA1c | Mean | Standard Deviation | % |
|
| OG000 | CDSMP | 6-week educational classes CDSMP : 6-week classes |
| OG001 | Personal Digital Assistant (PDA) | Personal digital assistance (technological) PDA : Technological assistance |
| OG002 | PDA/CDSMP | Combined intervention PDA/CDSMP : Combined technology and education |
| OG003 | Control | Usual Care |
|
|
|
| Secondary | BMI | Body mass index | BMI was computed from height & weight measurements from the 12-month follow-up (f/u) visit. Those unable to come in had height and weight abstracted from their EHRs. Measures recorded fell within the range of 10 days prior to and 45 days after participants' f/u visit dates. Those missing this information was not included in the analysis. | Posted | Mean | Standard Deviation | kg/m^2 | 12 months |
|
|
|
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| Secondary | Patient Self-reported Perceived Health Status | Perceived health status was collected using a questionnaire administered during the 12-month follow-up visit. Individuals who did not complete the questionnaire during the follow-up visit or who refused to answer the question were not included in the analysis. | Posted | Number | participants | 12 months |
|
|
|
|
| Secondary | Diabetes-related Behaviors | Participants were asked the number of days in the past 7 which they participated in various diabetes self-care activities on diet, exercise, home blood glucose monitoring, and foot care. | Those who completed a questionnaire at baseline and at their 12-month visit were included. Also, they had to have answered questions regarding self-care activities on both surveys since the calculated mean was the average difference in days within the past 7 that individuals participated in self-care activities between 12-months and baseline. | Posted | Mean | Standard Deviation | Days (e.g., Avg diff 12mo vs baseline) | 12 months |
|
|
|
|
| Secondary | Quality of Life (QOL) | Participants where asked the number of days in the past 30 days in which their physical (phys) and/or mental was not good, and whether their usual activity was affected by their physical/mental health. | Participants were included if they completed the 12-mo follow-up questionnaire. They also had to have answered questions pertaining to quality of life. Missing responses were not included. | Posted | Mean | Standard Deviation | Number of days | 12 months |
|
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Personal Digital Assistant (PDA) | Personal digital assistance (technological) PDA : Technological assistance | 0 | 81 | 0 | 81 |
| EG002 | PDA/CDSMP | Combined intervention PDA/CDSMP : Combined technology and education | 0 | 99 | 0 | 99 |
| EG003 | Control | Usual Care | 0 | 95 | 0 | 95 |
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| D004700 | Endocrine System Diseases |
| Very Good |
|
| Good |
|
| Fair |
|
| Poor |
|
| Test blood sugar the recommended times |
|
| Exercise at least 30 minutes |
|
| Participate in a specific exercise session |
|
| Check feet |
|
| Wash feet |
|
| Soak feet |
|
| Dry between toes |
|
| Inspect inside of shoes |
|
| Follow healthful eating plan |
|
| Space carbohydrates |
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| Eat 5+ servings of fruits and vegetables |
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| Eat high-fat foods |
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| Eat packaged foods (e.g., sweets and desserts) |
|
| Followed a healthful eating plan |
|
This analysis was to compare the average difference in days for the diabetes self-care activity, "Test blood sugar the recommended times." |
| ANOVA |
| 0.21 |
A priori threshold for statistical significance is <0.05 |
| 95 |
| No |
| Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Exercise at least 30 minutes." | ANOVA | 0.53 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Participate in a specific exercise session." | ANOVA | 0.24 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Check feet." | ANOVA | 0.18 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Wash feet." | ANOVA | 0.19 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Soak feet." | ANOVA | 0.87 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Dry between toes." | ANOVA | 0.53 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Inspect inside of shoes." | ANOVA | 0.32 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Follow healthful eating plan." | ANOVA | 0.37 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Space carbohydrates." | ANOVA | 0.72 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Eat 5+ servings of fruits and vegetables." | ANOVA | 0.59 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Eat high-fat foods." | ANOVA | <0.004 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Eat packaged foods (e.g., sweets and desserts)." | ANOVA | 0.66 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| This analysis was to compare the average difference in days for the diabetes self-care activity, "Followed a healthful eating plan." | ANOVA | 0.68 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |
| Mental health was not good in the past 30 days |
|
| Poor phys/mental health prevented usual activities |
|
This analysis was to compare the quality of life measure, "Number of days mental health was not good in the past 30 days" at the 12 month follow-up visit. |
| Regression, Linear |
Robust variance estimation. |
| 0.997 |
A priori threshold for statistical significance is <0.05 |
| 95 |
| No |
| Superiority or Other |
| This analysis was to compare the quality of life measure, "Number of days poor physical/mental health prevented usual activity in the past 30 days" at the 12 month follow-up visit. | Regression, Linear | Robust variance estimation. | 0.3067 | A priori threshold for statistical significance is <0.05 | 95 | No | Superiority or Other |