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Diabetes Self-Management Models to Reduce Health Disparities

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01221090
Acronym
P20-P2
Enrollment
376
Registered
2010-10-14
Start date
2009-01-31
Completion date
2012-05-31
Last updated
2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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

BEHAVIORALPDA

Technological assistance

BEHAVIORALCDSMP

6-week classes

BEHAVIORALPDA/CDSMP

Combined technology and education

Sponsors

Texas A&M University
CollaboratorOTHER
Scott and White Hospital & Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
HbA1c12 monthsMeasures 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

MeasureTime frameDescription
BMI12 monthsBody mass index
Patient Self-reported Perceived Health Status12 months
Diabetes-related Behaviors12 monthsParticipants 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 monthsParticipants 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

ArmCount
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
Total376

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyNon-Compliant or Unable to Contact15121520
Overall StudyWithdrawal by Subject022272

Baseline characteristics

CharacteristicPersonal Digital Assistant (PDA)TotalControlPDA/CDSMPCDSMP
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
25 Participants96 Participants25 Participants26 Participants20 Participants
Age, Categorical
Between 18 and 65 years
56 Participants280 Participants70 Participants73 Participants81 Participants
Age Continuous57.7 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
BMI35.3 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 Pressure73.6 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 Participants74 Participants21 Participants24 Participants16 Participants
Education
Graduate school
7 Participants47 Participants13 Participants14 Participants13 Participants
Education
High school graduate
20 Participants74 Participants21 Participants17 Participants16 Participants
Education
Less than high school
4 Participants16 Participants3 Participants3 Participants6 Participants
Education
Some college/vocational school
34 Participants149 Participants36 Participants33 Participants46 Participants
Education
Some high school
3 Participants16 Participants1 Participants8 Participants4 Participants
HbA1c9.3 %
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 Participants39 Participants9 Participants7 Participants12 Participants
Income
$15,000 - $24,999
14 Participants60 Participants16 Participants19 Participants11 Participants
Income
$25,000 - $49,999
37 Participants140 Participants30 Participants32 Participants41 Participants
Income
$50,000 - $75,000
12 Participants64 Participants17 Participants23 Participants12 Participants
Income
> $75,000
6 Participants46 Participants14 Participants14 Participants12 Participants
Income
Prefer not to answer
1 Participants27 Participants9 Participants4 Participants13 Participants
Minority
No
51 Participants239 Participants63 Participants65 Participants60 Participants
Minority
Yes
30 Participants137 Participants32 Participants34 Participants41 Participants
Race-Ethnicity
Hispanic
19 Participants76 Participants15 Participants22 Participants20 Participants
Race-Ethnicity
Non-Hispanic Black
11 Participants61 Participants17 Participants12 Participants21 Participants
Race-Ethnicity
Non-Hispanic White
49 Participants226 Participants58 Participants61 Participants58 Participants
Race-Ethnicity
Other
2 Participants13 Participants5 Participants4 Participants2 Participants
Region of Enrollment
United States
81 participants376 participants95 participants99 participants101 participants
Sex: Female, Male
Female
47 Participants207 Participants53 Participants53 Participants54 Participants
Sex: Female, Male
Male
34 Participants169 Participants42 Participants46 Participants47 Participants
Systolic Blood Pressure138.5 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 typeEG000
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 / 1010 / 810 / 990 / 95
serious
Total, serious adverse events
0 / 1010 / 810 / 990 / 95

Outcome results

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.

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.

ArmMeasureValue (MEAN)Dispersion
CDSMPHbA1c8.7 percentage of gycosylated HbA1cStandard Deviation 1.9
Personal Digital Assistant (PDA)HbA1c8.7 percentage of gycosylated HbA1cStandard Deviation 1.7
PDA/CDSMPHbA1c8.6 percentage of gycosylated HbA1cStandard Deviation 1.4
ControlHbA1c8.4 percentage of gycosylated HbA1cStandard Deviation 1.6
Comparison: We used a multilevel statistical model including time (in days) as a continuous variable, where 0=baseline. The lowest level of the hierarchy was repeated measurements of HbA1c on each subject, with participants themselves constituting the 2nd level. Forward selection was utilized, in which powers of time were added one at a time to the base model including treatment group effects. Interaction terms between time \& treatment effects were added gradually and evaluated with likelihood ratio tests.p-value: 0.771Likelihood Ratio Tests
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
CDSMPBMI34.9 kg/m^2Standard Deviation 9.2
Personal Digital Assistant (PDA)BMI35.8 kg/m^2Standard Deviation 7.6
PDA/CDSMPBMI32.8 kg/m^2Standard Deviation 5.5
ControlBMI33.9 kg/m^2Standard Deviation 8.4
p-value: 0.2176Regression, Linear
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.

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.

ArmMeasureGroupValue (MEAN)Dispersion
CDSMPDiabetes-related BehaviorsTest blood sugar0.26 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.01
CDSMPDiabetes-related BehaviorsEat 5+ servings of fruits and vegetables0.31 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.92
CDSMPDiabetes-related BehaviorsInspect inside of shoes1.47 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.53
CDSMPDiabetes-related BehaviorsExercise at least 30 minutes0.80 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.9
CDSMPDiabetes-related BehaviorsFollow healthful eating plan0.28 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.05
CDSMPDiabetes-related BehaviorsSpace carbohydrates0.15 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3
CDSMPDiabetes-related BehaviorsParticipate in a specific exercise session0 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.39
CDSMPDiabetes-related BehaviorsTest blood sugar the recommended times0.55 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.37
CDSMPDiabetes-related BehaviorsEat packaged foods (e.g., sweets and desserts)-0.09 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.26
CDSMPDiabetes-related BehaviorsCheck feet1.84 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.99
CDSMPDiabetes-related BehaviorsWash feet0.52 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.55
CDSMPDiabetes-related BehaviorsEat high-fat foods-0.98 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.17
CDSMPDiabetes-related BehaviorsSoak feet0.74 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.29
CDSMPDiabetes-related BehaviorsFollowed a healthful eating plan0.32 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.97
CDSMPDiabetes-related BehaviorsDry between toes0.53 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.52
Personal Digital Assistant (PDA)Diabetes-related BehaviorsDry between toes0.36 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.91
Personal Digital Assistant (PDA)Diabetes-related BehaviorsEat 5+ servings of fruits and vegetables0.64 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.46
Personal Digital Assistant (PDA)Diabetes-related BehaviorsCheck feet0.36 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.11
Personal Digital Assistant (PDA)Diabetes-related BehaviorsInspect inside of shoes0.82 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.89
Personal Digital Assistant (PDA)Diabetes-related BehaviorsTest 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 BehaviorsSpace carbohydrates-0.36 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.67
Personal Digital Assistant (PDA)Diabetes-related BehaviorsEat high-fat foods1.45 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.34
Personal Digital Assistant (PDA)Diabetes-related BehaviorsFollow healthful eating plan-0.36 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.96
Personal Digital Assistant (PDA)Diabetes-related BehaviorsExercise at least 30 minutes0.09 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.39
Personal Digital Assistant (PDA)Diabetes-related BehaviorsSoak feet1.00 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2
Personal Digital Assistant (PDA)Diabetes-related BehaviorsFollowed a healthful eating plan-0.36 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.63
Personal Digital Assistant (PDA)Diabetes-related BehaviorsEat 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 BehaviorsWash feet0.09 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.7
Personal Digital Assistant (PDA)Diabetes-related BehaviorsParticipate 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 BehaviorsTest blood sugar-0.91 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.12
PDA/CDSMPDiabetes-related BehaviorsDry between toes1.53 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.04
PDA/CDSMPDiabetes-related BehaviorsTest blood sugar0.10 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.05
PDA/CDSMPDiabetes-related BehaviorsTest blood sugar the recommended times0.11 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.4
PDA/CDSMPDiabetes-related BehaviorsExercise at least 30 minutes-0.16 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.22
PDA/CDSMPDiabetes-related BehaviorsParticipate in a specific exercise session0.37 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.89
PDA/CDSMPDiabetes-related BehaviorsCheck feet0.65 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.66
PDA/CDSMPDiabetes-related BehaviorsWash feet-0.05 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1
PDA/CDSMPDiabetes-related BehaviorsSoak feet0.55 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.5
PDA/CDSMPDiabetes-related BehaviorsInspect inside of shoes0.20 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.16
PDA/CDSMPDiabetes-related BehaviorsFollow healthful eating plan0.60 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.44
PDA/CDSMPDiabetes-related BehaviorsSpace carbohydrates0.60 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.58
PDA/CDSMPDiabetes-related BehaviorsEat 5+ servings of fruits and vegetables0.35 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.06
PDA/CDSMPDiabetes-related BehaviorsEat high-fat foods0.53 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.29
PDA/CDSMPDiabetes-related BehaviorsEat packaged foods (e.g., sweets and desserts)0 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.68
PDA/CDSMPDiabetes-related BehaviorsFollowed a healthful eating plan0.50 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.37
ControlDiabetes-related BehaviorsSoak feet0.32 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.13
ControlDiabetes-related BehaviorsTest blood sugar the recommended times1.21 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.28
ControlDiabetes-related BehaviorsEat 5+ servings of fruits and vegetables1.10 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.14
ControlDiabetes-related BehaviorsWash feet-0.17 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 1.37
ControlDiabetes-related BehaviorsCheck feet0.63 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.11
ControlDiabetes-related BehaviorsTest blood sugar0.97 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.76
ControlDiabetes-related BehaviorsEat high-fat foods-0.72 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.2
ControlDiabetes-related BehaviorsParticipate in a specific exercise session0.72 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.06
ControlDiabetes-related BehaviorsExercise at least 30 minutes0.70 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.44
ControlDiabetes-related BehaviorsFollowed a healthful eating plan0.52 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.34
ControlDiabetes-related BehaviorsFollow healthful eating plan0.93 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.45
ControlDiabetes-related BehaviorsInspect inside of shoes0.11 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 3.57
ControlDiabetes-related BehaviorsEat packaged foods (e.g., sweets and desserts)-0.66 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.02
ControlDiabetes-related BehaviorsSpace carbohydrates0.64 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.28
ControlDiabetes-related BehaviorsDry between toes0.76 Days (e.g., Avg diff 12mo vs baseline)Standard Deviation 2.67
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar.p-value: 0.26ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar the recommended times.p-value: 0.21ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Exercise at least 30 minutes.p-value: 0.53ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Participate in a specific exercise session.p-value: 0.24ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Check feet.p-value: 0.18ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Wash feet.p-value: 0.19ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Soak feet.p-value: 0.87ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Dry between toes.p-value: 0.53ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Inspect inside of shoes.p-value: 0.32ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Follow healthful eating plan.p-value: 0.37ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Space carbohydrates.p-value: 0.72ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Eat 5+ servings of fruits and vegetables.p-value: 0.59ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Eat high-fat foods.p-value: <0.004ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Eat packaged foods (e.g., sweets and desserts).p-value: 0.66ANOVA
Comparison: This analysis was to compare the average difference in days for the diabetes self-care activity, Followed a healthful eating plan.p-value: 0.68ANOVA
Secondary

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.

ArmMeasureGroupValue (NUMBER)
CDSMPPatient Self-reported Perceived Health StatusVery Good13 participants
CDSMPPatient Self-reported Perceived Health StatusGood19 participants
CDSMPPatient Self-reported Perceived Health StatusExcellent3 participants
CDSMPPatient Self-reported Perceived Health StatusFair10 participants
CDSMPPatient Self-reported Perceived Health StatusPoor1 participants
Personal Digital Assistant (PDA)Patient Self-reported Perceived Health StatusGood6 participants
Personal Digital Assistant (PDA)Patient Self-reported Perceived Health StatusFair2 participants
Personal Digital Assistant (PDA)Patient Self-reported Perceived Health StatusPoor0 participants
Personal Digital Assistant (PDA)Patient Self-reported Perceived Health StatusExcellent0 participants
Personal Digital Assistant (PDA)Patient Self-reported Perceived Health StatusVery Good3 participants
PDA/CDSMPPatient Self-reported Perceived Health StatusPoor0 participants
PDA/CDSMPPatient Self-reported Perceived Health StatusExcellent1 participants
PDA/CDSMPPatient Self-reported Perceived Health StatusFair9 participants
PDA/CDSMPPatient Self-reported Perceived Health StatusVery Good6 participants
PDA/CDSMPPatient Self-reported Perceived Health StatusGood4 participants
ControlPatient Self-reported Perceived Health StatusFair8 participants
ControlPatient Self-reported Perceived Health StatusGood14 participants
ControlPatient Self-reported Perceived Health StatusPoor2 participants
ControlPatient Self-reported Perceived Health StatusExcellent1 participants
ControlPatient Self-reported Perceived Health StatusVery Good5 participants
p-value: 0.572Fisher Exact
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.

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.

ArmMeasureGroupValue (MEAN)Dispersion
CDSMPQuality of Life (QOL)Physical health was not good in the past 30 days5.9 Number of daysStandard Deviation 8.7
CDSMPQuality of Life (QOL)Poor phys/mental health prevented usual activities3.8 Number of daysStandard Deviation 7.2
CDSMPQuality of Life (QOL)Mental health was not good in the past 30 days6.8 Number of daysStandard Deviation 9.6
Personal Digital Assistant (PDA)Quality of Life (QOL)Physical health was not good in the past 30 days9.0 Number of daysStandard Deviation 11.7
Personal Digital Assistant (PDA)Quality of Life (QOL)Poor phys/mental health prevented usual activities7.3 Number of daysStandard Deviation 12.6
Personal Digital Assistant (PDA)Quality of Life (QOL)Mental health was not good in the past 30 days7.2 Number of daysStandard Deviation 12.6
PDA/CDSMPQuality of Life (QOL)Mental health was not good in the past 30 days7.3 Number of daysStandard Deviation 11
PDA/CDSMPQuality of Life (QOL)Physical health was not good in the past 30 days8.5 Number of daysStandard Deviation 10.2
PDA/CDSMPQuality of Life (QOL)Poor phys/mental health prevented usual activities7.8 Number of daysStandard Deviation 9.1
ControlQuality of Life (QOL)Physical health was not good in the past 30 days7.3 Number of daysStandard Deviation 8.8
ControlQuality of Life (QOL)Poor phys/mental health prevented usual activities5.4 Number of daysStandard Deviation 9.3
ControlQuality of Life (QOL)Mental health was not good in the past 30 days6.6 Number of daysStandard Deviation 10.2
Comparison: This analysis was to compare the quality of life measure, Number of days physical health was not good in the past 30 days at the 12 month follow-up visit.p-value: 0.685Regression, Linear
Comparison: 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.p-value: 0.997Regression, Linear
Comparison: 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.p-value: 0.3067Regression, Linear

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026