Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Health disparities, Central Texas, PDA, CDSMP
Brief summary
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.
Detailed description
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.
Interventions
Technological assistance
6-week classes
Combined technology and education
Sponsors
Study design
Eligibility
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 12 months | Body mass index |
| Patient Self-reported Perceived Health Status | 12 months | — |
| Diabetes-related Behaviors | 12 months | 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. |
| Quality of Life (QOL) | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CDSMP 6-week educational classes
CDSMP : 6-week classes | 101 |
| Personal Digital Assistant (PDA) Personal digital assistance (technological)
PDA : Technological assistance | 81 |
| PDA/CDSMP Combined intervention
PDA/CDSMP : Combined technology and education | 99 |
| Control Usual Care | 95 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Non-Compliant or Unable to Contact | 15 | 12 | 15 | 20 |
| Overall Study | Withdrawal by Subject | 0 | 22 | 27 | 2 |
Baseline characteristics
| Characteristic | Personal Digital Assistant (PDA) | Total | Control | PDA/CDSMP | CDSMP |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 96 Participants | 25 Participants | 26 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 280 Participants | 70 Participants | 73 Participants | 81 Participants |
| Age Continuous | 57.7 years STANDARD_DEVIATION 10.8 | 57.6 years STANDARD_DEVIATION 10.9 | 58.5 years STANDARD_DEVIATION 11.9 | 57.7 years STANDARD_DEVIATION 10.3 | 56.4 years STANDARD_DEVIATION 10.8 |
| BMI | 35.3 kg/m^2 STANDARD_DEVIATION 7.3 | 34.3 kg/m^2 STANDARD_DEVIATION 7.4 | 33.9 kg/m^2 STANDARD_DEVIATION 7.7 | 34.6 kg/m^2 STANDARD_DEVIATION 6.3 | 33.5 kg/m^2 STANDARD_DEVIATION 8 |
| Diastolic Blood Pressure | 73.6 mm/Hg STANDARD_DEVIATION 11 | 77 mm/Hg STANDARD_DEVIATION 11.7 | 75.8 mm/Hg STANDARD_DEVIATION 13.6 | 78.8 mm/Hg STANDARD_DEVIATION 11.4 | 79.4 mm/Hg STANDARD_DEVIATION 9.8 |
| Education College graduate | 13 Participants | 74 Participants | 21 Participants | 24 Participants | 16 Participants |
| Education Graduate school | 7 Participants | 47 Participants | 13 Participants | 14 Participants | 13 Participants |
| Education High school graduate | 20 Participants | 74 Participants | 21 Participants | 17 Participants | 16 Participants |
| Education Less than high school | 4 Participants | 16 Participants | 3 Participants | 3 Participants | 6 Participants |
| Education Some college/vocational school | 34 Participants | 149 Participants | 36 Participants | 33 Participants | 46 Participants |
| Education Some high school | 3 Participants | 16 Participants | 1 Participants | 8 Participants | 4 Participants |
| HbA1c | 9.3 % STANDARD_DEVIATION 1.6 | 9.3 % STANDARD_DEVIATION 1.6 | 9.2 % STANDARD_DEVIATION 1.6 | 9.2 % STANDARD_DEVIATION 1.4 | 9.4 % STANDARD_DEVIATION 1.7 |
| Income < $15,000 | 11 Participants | 39 Participants | 9 Participants | 7 Participants | 12 Participants |
| Income $15,000 - $24,999 | 14 Participants | 60 Participants | 16 Participants | 19 Participants | 11 Participants |
| Income $25,000 - $49,999 | 37 Participants | 140 Participants | 30 Participants | 32 Participants | 41 Participants |
| Income $50,000 - $75,000 | 12 Participants | 64 Participants | 17 Participants | 23 Participants | 12 Participants |
| Income > $75,000 | 6 Participants | 46 Participants | 14 Participants | 14 Participants | 12 Participants |
| Income Prefer not to answer | 1 Participants | 27 Participants | 9 Participants | 4 Participants | 13 Participants |
| Minority No | 51 Participants | 239 Participants | 63 Participants | 65 Participants | 60 Participants |
| Minority Yes | 30 Participants | 137 Participants | 32 Participants | 34 Participants | 41 Participants |
| Race-Ethnicity Hispanic | 19 Participants | 76 Participants | 15 Participants | 22 Participants | 20 Participants |
| Race-Ethnicity Non-Hispanic Black | 11 Participants | 61 Participants | 17 Participants | 12 Participants | 21 Participants |
| Race-Ethnicity Non-Hispanic White | 49 Participants | 226 Participants | 58 Participants | 61 Participants | 58 Participants |
| Race-Ethnicity Other | 2 Participants | 13 Participants | 5 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 81 participants | 376 participants | 95 participants | 99 participants | 101 participants |
| Sex: Female, Male Female | 47 Participants | 207 Participants | 53 Participants | 53 Participants | 54 Participants |
| Sex: Female, Male Male | 34 Participants | 169 Participants | 42 Participants | 46 Participants | 47 Participants |
| Systolic Blood Pressure | 138.5 mm/Hg STANDARD_DEVIATION 21.2 | 134.8 mm/Hg STANDARD_DEVIATION 19.3 | 132.9 mm/Hg STANDARD_DEVIATION 21.7 | 136.2 mm/Hg STANDARD_DEVIATION 19.1 | 131.9 mm/Hg STANDARD_DEVIATION 14.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 81 | 0 / 99 | 0 / 95 |
| serious Total, serious adverse events | 0 / 101 | 0 / 81 | 0 / 99 | 0 / 95 |
Outcome results
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDSMP | HbA1c | 8.7 percentage of gycosylated HbA1c | Standard Deviation 1.9 |
| Personal Digital Assistant (PDA) | HbA1c | 8.7 percentage of gycosylated HbA1c | Standard Deviation 1.7 |
| PDA/CDSMP | HbA1c | 8.6 percentage of gycosylated HbA1c | Standard Deviation 1.4 |
| Control | HbA1c | 8.4 percentage of gycosylated HbA1c | Standard Deviation 1.6 |
BMI
Body mass index
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CDSMP | BMI | 34.9 kg/m^2 | Standard Deviation 9.2 |
| Personal Digital Assistant (PDA) | BMI | 35.8 kg/m^2 | Standard Deviation 7.6 |
| PDA/CDSMP | BMI | 32.8 kg/m^2 | Standard Deviation 5.5 |
| Control | BMI | 33.9 kg/m^2 | Standard Deviation 8.4 |
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CDSMP | Diabetes-related Behaviors | Test blood sugar | 0.26 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.01 |
| CDSMP | Diabetes-related Behaviors | Eat 5+ servings of fruits and vegetables | 0.31 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.92 |
| CDSMP | Diabetes-related Behaviors | Inspect inside of shoes | 1.47 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.53 |
| CDSMP | Diabetes-related Behaviors | Exercise at least 30 minutes | 0.80 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.9 |
| CDSMP | Diabetes-related Behaviors | Follow healthful eating plan | 0.28 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.05 |
| CDSMP | Diabetes-related Behaviors | Space carbohydrates | 0.15 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3 |
| CDSMP | Diabetes-related Behaviors | Participate in a specific exercise session | 0 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.39 |
| CDSMP | Diabetes-related Behaviors | Test blood sugar the recommended times | 0.55 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.37 |
| CDSMP | Diabetes-related Behaviors | Eat packaged foods (e.g., sweets and desserts) | -0.09 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.26 |
| CDSMP | Diabetes-related Behaviors | Check feet | 1.84 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.99 |
| CDSMP | Diabetes-related Behaviors | Wash feet | 0.52 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.55 |
| CDSMP | Diabetes-related Behaviors | Eat high-fat foods | -0.98 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.17 |
| CDSMP | Diabetes-related Behaviors | Soak feet | 0.74 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.29 |
| CDSMP | Diabetes-related Behaviors | Followed a healthful eating plan | 0.32 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.97 |
| CDSMP | Diabetes-related Behaviors | Dry between toes | 0.53 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.52 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Dry between toes | 0.36 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.91 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Eat 5+ servings of fruits and vegetables | 0.64 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.46 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Check feet | 0.36 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.11 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Inspect inside of shoes | 0.82 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.89 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Test blood sugar the recommended times | -1.22 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.28 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Space carbohydrates | -0.36 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.67 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Eat high-fat foods | 1.45 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.34 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Follow healthful eating plan | -0.36 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.96 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Exercise at least 30 minutes | 0.09 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.39 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Soak feet | 1.00 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Followed a healthful eating plan | -0.36 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.63 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Eat packaged foods (e.g., sweets and desserts) | 0 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 0.63 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Wash feet | 0.09 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.7 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Participate in a specific exercise session | -1.00 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.61 |
| Personal Digital Assistant (PDA) | Diabetes-related Behaviors | Test blood sugar | -0.91 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.12 |
| PDA/CDSMP | Diabetes-related Behaviors | Dry between toes | 1.53 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.04 |
| PDA/CDSMP | Diabetes-related Behaviors | Test blood sugar | 0.10 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.05 |
| PDA/CDSMP | Diabetes-related Behaviors | Test blood sugar the recommended times | 0.11 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.4 |
| PDA/CDSMP | Diabetes-related Behaviors | Exercise at least 30 minutes | -0.16 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.22 |
| PDA/CDSMP | Diabetes-related Behaviors | Participate in a specific exercise session | 0.37 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.89 |
| PDA/CDSMP | Diabetes-related Behaviors | Check feet | 0.65 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.66 |
| PDA/CDSMP | Diabetes-related Behaviors | Wash feet | -0.05 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1 |
| PDA/CDSMP | Diabetes-related Behaviors | Soak feet | 0.55 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.5 |
| PDA/CDSMP | Diabetes-related Behaviors | Inspect inside of shoes | 0.20 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.16 |
| PDA/CDSMP | Diabetes-related Behaviors | Follow healthful eating plan | 0.60 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.44 |
| PDA/CDSMP | Diabetes-related Behaviors | Space carbohydrates | 0.60 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.58 |
| PDA/CDSMP | Diabetes-related Behaviors | Eat 5+ servings of fruits and vegetables | 0.35 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.06 |
| PDA/CDSMP | Diabetes-related Behaviors | Eat high-fat foods | 0.53 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.29 |
| PDA/CDSMP | Diabetes-related Behaviors | Eat packaged foods (e.g., sweets and desserts) | 0 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.68 |
| PDA/CDSMP | Diabetes-related Behaviors | Followed a healthful eating plan | 0.50 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.37 |
| Control | Diabetes-related Behaviors | Soak feet | 0.32 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.13 |
| Control | Diabetes-related Behaviors | Test blood sugar the recommended times | 1.21 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.28 |
| Control | Diabetes-related Behaviors | Eat 5+ servings of fruits and vegetables | 1.10 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.14 |
| Control | Diabetes-related Behaviors | Wash feet | -0.17 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 1.37 |
| Control | Diabetes-related Behaviors | Check feet | 0.63 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.11 |
| Control | Diabetes-related Behaviors | Test blood sugar | 0.97 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.76 |
| Control | Diabetes-related Behaviors | Eat high-fat foods | -0.72 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.2 |
| Control | Diabetes-related Behaviors | Participate in a specific exercise session | 0.72 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.06 |
| Control | Diabetes-related Behaviors | Exercise at least 30 minutes | 0.70 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.44 |
| Control | Diabetes-related Behaviors | Followed a healthful eating plan | 0.52 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.34 |
| Control | Diabetes-related Behaviors | Follow healthful eating plan | 0.93 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.45 |
| Control | Diabetes-related Behaviors | Inspect inside of shoes | 0.11 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 3.57 |
| Control | Diabetes-related Behaviors | Eat packaged foods (e.g., sweets and desserts) | -0.66 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.02 |
| Control | Diabetes-related Behaviors | Space carbohydrates | 0.64 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.28 |
| Control | Diabetes-related Behaviors | Dry between toes | 0.76 Days (e.g., Avg diff 12mo vs baseline) | Standard Deviation 2.67 |
Patient Self-reported Perceived Health Status
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CDSMP | Patient Self-reported Perceived Health Status | Very Good | 13 participants |
| CDSMP | Patient Self-reported Perceived Health Status | Good | 19 participants |
| CDSMP | Patient Self-reported Perceived Health Status | Excellent | 3 participants |
| CDSMP | Patient Self-reported Perceived Health Status | Fair | 10 participants |
| CDSMP | Patient Self-reported Perceived Health Status | Poor | 1 participants |
| Personal Digital Assistant (PDA) | Patient Self-reported Perceived Health Status | Good | 6 participants |
| Personal Digital Assistant (PDA) | Patient Self-reported Perceived Health Status | Fair | 2 participants |
| Personal Digital Assistant (PDA) | Patient Self-reported Perceived Health Status | Poor | 0 participants |
| Personal Digital Assistant (PDA) | Patient Self-reported Perceived Health Status | Excellent | 0 participants |
| Personal Digital Assistant (PDA) | Patient Self-reported Perceived Health Status | Very Good | 3 participants |
| PDA/CDSMP | Patient Self-reported Perceived Health Status | Poor | 0 participants |
| PDA/CDSMP | Patient Self-reported Perceived Health Status | Excellent | 1 participants |
| PDA/CDSMP | Patient Self-reported Perceived Health Status | Fair | 9 participants |
| PDA/CDSMP | Patient Self-reported Perceived Health Status | Very Good | 6 participants |
| PDA/CDSMP | Patient Self-reported Perceived Health Status | Good | 4 participants |
| Control | Patient Self-reported Perceived Health Status | Fair | 8 participants |
| Control | Patient Self-reported Perceived Health Status | Good | 14 participants |
| Control | Patient Self-reported Perceived Health Status | Poor | 2 participants |
| Control | Patient Self-reported Perceived Health Status | Excellent | 1 participants |
| Control | Patient Self-reported Perceived Health Status | Very Good | 5 participants |
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CDSMP | Quality of Life (QOL) | Physical health was not good in the past 30 days | 5.9 Number of days | Standard Deviation 8.7 |
| CDSMP | Quality of Life (QOL) | Poor phys/mental health prevented usual activities | 3.8 Number of days | Standard Deviation 7.2 |
| CDSMP | Quality of Life (QOL) | Mental health was not good in the past 30 days | 6.8 Number of days | Standard Deviation 9.6 |
| Personal Digital Assistant (PDA) | Quality of Life (QOL) | Physical health was not good in the past 30 days | 9.0 Number of days | Standard Deviation 11.7 |
| Personal Digital Assistant (PDA) | Quality of Life (QOL) | Poor phys/mental health prevented usual activities | 7.3 Number of days | Standard Deviation 12.6 |
| Personal Digital Assistant (PDA) | Quality of Life (QOL) | Mental health was not good in the past 30 days | 7.2 Number of days | Standard Deviation 12.6 |
| PDA/CDSMP | Quality of Life (QOL) | Mental health was not good in the past 30 days | 7.3 Number of days | Standard Deviation 11 |
| PDA/CDSMP | Quality of Life (QOL) | Physical health was not good in the past 30 days | 8.5 Number of days | Standard Deviation 10.2 |
| PDA/CDSMP | Quality of Life (QOL) | Poor phys/mental health prevented usual activities | 7.8 Number of days | Standard Deviation 9.1 |
| Control | Quality of Life (QOL) | Physical health was not good in the past 30 days | 7.3 Number of days | Standard Deviation 8.8 |
| Control | Quality of Life (QOL) | Poor phys/mental health prevented usual activities | 5.4 Number of days | Standard Deviation 9.3 |
| Control | Quality of Life (QOL) | Mental health was not good in the past 30 days | 6.6 Number of days | Standard Deviation 10.2 |