A Phase 4 interventional study of PDA and CDSMP in Type 2 Diabetes, sponsored by Scott and White Hospital & Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-14.
Sponsored by Scott and White Hospital & Clinic · Phase 4, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 376 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Scott and White Hospital & Clinic is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: PDA
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.
Behavioral: CDSMP
Combined intervention
Behavioral: PDA/CDSMP
Usual Care
Technological assistance
Also known as: Personal digital assistant
6-week classes
Also known as: Chronic disease self-management program
Combined technology and education
Also known as: PDA + CDSMP
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.
Time frame: 12 months
BMI
Body mass index
Time frame: 12 months
Patient Self-reported Perceived Health Status
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
| Milestone | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control |
|---|---|---|---|---|
| Started | 101 | 81 | 99 | 95 |
| Completed | 86 | 47 | 57 | 73 |
| Not completed | 15 | 34 | 42 | 22 |
| Withdrew: Non-compliant or unable to contact | 15 | 12 | 15 | 20 |
| Withdrew: Withdrawal by subject | 0 | 22 | 27 | 2 |
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.
| percentage of gycosylated HbA1c | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control |
|---|---|---|---|---|
| HbA1c | 8.7 ± 1.9 | 8.7 ± 1.7 | 8.6 ± 1.4 | 8.4 ± 1.6 |
Body mass index
| kg/m^2 | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control |
|---|---|---|---|---|
| BMI | 34.9 ± 9.2 | 35.8 ± 7.6 | 32.8 ± 5.5 | 33.9 ± 8.4 |
| participants | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control |
|---|---|---|---|---|
| Excellent | 3 | 0 | 1 | 1 |
| Very Good | 13 | 3 | 6 | 5 |
| Good | 19 | 6 | 4 | 14 |
| Fair | 10 | 2 | 9 | 8 |
| Poor | 1 | 0 | 0 | 2 |
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.
| Days (e.g., Avg diff 12mo vs baseline) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control |
|---|---|---|---|---|
| Test blood sugar | 0.26 ± 3.01 | -0.91 ± 2.12 | 0.10 ± 2.05 | 0.97 ± 2.76 |
| Test blood sugar the recommended times | 0.55 ± 3.37 | -1.22 ± 2.28 | 0.11 ± 2.40 | 1.21 ± 3.28 |
| Exercise at least 30 minutes | 0.80 ± 2.90 | 0.09 ± 2.39 | -0.16 ± 2.22 | 0.70 ± 2.44 |
| Participate in a specific exercise session | 0 ± 2.39 | -1.00 ± 1.61 | 0.37 ± 1.89 | 0.72 ± 3.06 |
| Check feet | 1.84 ± 2.99 | 0.36 ± 2.11 | 0.65 ± 2.66 | 0.63 ± 3.11 |
| Wash feet | 0.52 ± 1.55 | 0.09 ± 1.70 | -0.05 ± 1.00 | -0.17 ± 1.37 |
| Soak feet | 0.74 ± 2.29 | 1.00 ± 2.00 | 0.55 ± 2.50 | 0.32 ± 3.13 |
| Dry between toes | 0.53 ± 2.52 | 0.36 ± 1.91 | 1.53 ± 3.04 | 0.76 ± 2.67 |
| Inspect inside of shoes | 1.47 ± 3.53 | 0.82 ± 1.89 | 0.20 ± 3.16 | 0.11 ± 3.57 |
| Follow healthful eating plan | 0.28 ± 2.05 | -0.36 ± 1.96 | 0.60 ± 2.44 | 0.93 ± 2.45 |
| Space carbohydrates | 0.15 ± 3.00 | -0.36 ± 3.67 | 0.60 ± 2.58 | 0.64 ± 2.28 |
| Eat 5+ servings of fruits and vegetables | 0.31 ± 2.92 | 0.64 ± 2.46 | 0.35 ± 2.06 | 1.10 ± 2.14 |
| Eat high-fat foods | -0.98 ± 2.17 | 1.45 ± 2.34 | 0.53 ± 2.29 | -0.72 ± 2.20 |
| Eat packaged foods (e.g., sweets and desserts) | -0.09 ± 2.26 | 0 ± 0.63 | 0 ± 2.68 | -0.66 ± 2.02 |
| Followed a healthful eating plan | 0.32 ± 1.97 | -0.36 ± 1.63 | 0.50 ± 2.37 | 0.52 ± 2.34 |
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.
| Number of days | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control |
|---|---|---|---|---|
| Physical health was not good in the past 30 days | 5.9 ± 8.7 | 9.0 ± 11.7 | 8.5 ± 10.2 | 7.3 ± 8.8 |
| Mental health was not good in the past 30 days | 6.8 ± 9.6 | 7.2 ± 12.6 | 7.3 ± 11.0 | 6.6 ± 10.2 |
| Poor phys/mental health prevented usual activities | 3.8 ± 7.2 | 7.3 ± 12.6 | 7.8 ± 9.1 | 5.4 ± 9.3 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CDSMP | — | 0/101 (0%) | 0/101 (0%) |
| Personal Digital Assistant (PDA) | — | 0/81 (0%) | 0/81 (0%) |
| PDA/CDSMP | — | 0/99 (0%) | 0/99 (0%) |
| Control | — | 0/95 (0%) | 0/95 (0%) |
| Age, Categorical(Participants) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 81 | 56 | 73 | 70 | 280 |
| >=65 years | 20 | 25 | 26 | 25 | 96 |
| Age Continuous(years) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| Mean | 56.4 ± 10.8 | 57.7 ± 10.8 | 57.7 ± 10.3 | 58.5 ± 11.9 | 57.6 ± 10.9 |
| Sex: Female, Male(Participants) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| Female | 54 | 47 | 53 | 53 | 207 |
| Male | 47 | 34 | 46 | 42 | 169 |
| Region of Enrollment(participants) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| United States | 101 | 81 | 99 | 95 | 376 |
| Minority(Participants) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| No | 60 | 51 | 65 | 63 | 239 |
| Yes | 41 | 30 | 34 | 32 | 137 |
| Race-Ethnicity(Participants) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| Non-Hispanic White | 58 | 49 | 61 | 58 | 226 |
| Non-Hispanic Black | 21 | 11 | 12 | 17 | 61 |
| Hispanic | 20 | 19 | 22 | 15 | 76 |
| Other | 2 | 2 | 4 | 5 | 13 |
| Education(Participants) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| Less than high school | 6 | 4 | 3 | 3 | 16 |
| Some high school | 4 | 3 | 8 | 1 | 16 |
| High school graduate | 16 | 20 | 17 | 21 | 74 |
| Some college/vocational school | 46 | 34 | 33 | 36 | 149 |
| College graduate | 16 | 13 | 24 | 21 | 74 |
| Graduate school | 13 | 7 | 14 | 13 | 47 |
| Income(Participants) | CDSMP | Personal Digital Assistant (PDA) | PDA/CDSMP | Control | Total |
|---|---|---|---|---|---|
| < $15,000 | 12 | 11 | 7 | 9 | 39 |
| $15,000 - $24,999 | 11 | 14 | 19 | 16 | 60 |
| $25,000 - $49,999 | 41 | 37 | 32 | 30 | 140 |
| $50,000 - $75,000 | 12 | 12 | 23 | 17 | 64 |
| > $75,000 | 12 | 6 | 14 | 14 | 46 |
| Prefer not to answer | 13 | 1 | 4 | 9 | 27 |
4 further baseline measures are reported on the registry.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Scott and White Hospital & Clinic