Trial Outcomes & Findings for Diabetes Self-Management Models to Reduce Health Disparities (NCT NCT01221090)
NCT ID: NCT01221090
Last Updated: 2013-10-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
376 participants
Primary outcome timeframe
12 months
Results posted on
2013-10-14
Participant Flow
Participant milestones
| Measure |
CDSMP
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
Usual Care
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
81
|
99
|
95
|
|
Overall Study
COMPLETED
|
86
|
47
|
57
|
73
|
|
Overall Study
NOT COMPLETED
|
15
|
34
|
42
|
22
|
Reasons for withdrawal
| Measure |
CDSMP
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
Usual Care
|
|---|---|---|---|---|
|
Overall Study
Non-Compliant or Unable to Contact
|
15
|
12
|
15
|
20
|
|
Overall Study
Withdrawal by Subject
|
0
|
22
|
27
|
2
|
Baseline Characteristics
Diabetes Self-Management Models to Reduce Health Disparities
Baseline characteristics by cohort
| Measure |
CDSMP
n=101 Participants
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
n=81 Participants
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
n=99 Participants
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
n=95 Participants
Usual Care
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
280 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Age Continuous
|
56.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
57.6 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
207 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
169 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
81 participants
n=7 Participants
|
99 participants
n=5 Participants
|
95 participants
n=4 Participants
|
376 participants
n=21 Participants
|
|
Minority
No
|
60 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
239 Participants
n=21 Participants
|
|
Minority
Yes
|
41 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
|
Race-Ethnicity
Non-Hispanic White
|
58 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
Race-Ethnicity
Non-Hispanic Black
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race-Ethnicity
Hispanic
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race-Ethnicity
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Education
Less than high school
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Education
Some high school
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Education
High school graduate
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Education
Some college/vocational school
|
46 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Education
College graduate
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Education
Graduate school
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Income
< $15,000
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Income
$15,000 - $24,999
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Income
$25,000 - $49,999
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Income
$50,000 - $75,000
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Income
> $75,000
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Income
Prefer not to answer
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
BMI
|
33.5 kg/m^2
STANDARD_DEVIATION 8 • n=5 Participants
|
35.3 kg/m^2
STANDARD_DEVIATION 7.3 • n=7 Participants
|
34.6 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
33.9 kg/m^2
STANDARD_DEVIATION 7.7 • n=4 Participants
|
34.3 kg/m^2
STANDARD_DEVIATION 7.4 • n=21 Participants
|
|
Systolic Blood Pressure
|
131.9 mm/Hg
STANDARD_DEVIATION 14.1 • n=5 Participants
|
138.5 mm/Hg
STANDARD_DEVIATION 21.2 • n=7 Participants
|
136.2 mm/Hg
STANDARD_DEVIATION 19.1 • n=5 Participants
|
132.9 mm/Hg
STANDARD_DEVIATION 21.7 • n=4 Participants
|
134.8 mm/Hg
STANDARD_DEVIATION 19.3 • n=21 Participants
|
|
Diastolic Blood Pressure
|
79.4 mm/Hg
STANDARD_DEVIATION 9.8 • n=5 Participants
|
73.6 mm/Hg
STANDARD_DEVIATION 11 • n=7 Participants
|
78.8 mm/Hg
STANDARD_DEVIATION 11.4 • n=5 Participants
|
75.8 mm/Hg
STANDARD_DEVIATION 13.6 • n=4 Participants
|
77 mm/Hg
STANDARD_DEVIATION 11.7 • n=21 Participants
|
|
HbA1c
|
9.4 %
STANDARD_DEVIATION 1.7 • n=5 Participants
|
9.3 %
STANDARD_DEVIATION 1.6 • n=7 Participants
|
9.2 %
STANDARD_DEVIATION 1.4 • n=5 Participants
|
9.2 %
STANDARD_DEVIATION 1.6 • n=4 Participants
|
9.3 %
STANDARD_DEVIATION 1.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CDSMP
n=388 HbA1c
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
n=267 HbA1c
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
n=307 HbA1c
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
n=365 HbA1c
Usual Care
|
|---|---|---|---|---|
|
HbA1c
|
8.7 percentage of gycosylated HbA1c
Standard Deviation 1.9
|
8.7 percentage of gycosylated HbA1c
Standard Deviation 1.7
|
8.6 percentage of gycosylated HbA1c
Standard Deviation 1.4
|
8.4 percentage of gycosylated HbA1c
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Body mass index
Outcome measures
| Measure |
CDSMP
n=67 Participants
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
n=30 Participants
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
n=39 Participants
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
n=56 Participants
Usual Care
|
|---|---|---|---|---|
|
BMI
|
34.9 kg/m^2
Standard Deviation 9.2
|
35.8 kg/m^2
Standard Deviation 7.6
|
32.8 kg/m^2
Standard Deviation 5.5
|
33.9 kg/m^2
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Outcome measures
| Measure |
CDSMP
n=46 Participants
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
n=11 Participants
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
n=20 Participants
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
n=30 Participants
Usual Care
|
|---|---|---|---|---|
|
Patient Self-reported Perceived Health Status
Excellent
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Patient Self-reported Perceived Health Status
Very Good
|
13 participants
|
3 participants
|
6 participants
|
5 participants
|
|
Patient Self-reported Perceived Health Status
Good
|
19 participants
|
6 participants
|
4 participants
|
14 participants
|
|
Patient Self-reported Perceived Health Status
Fair
|
10 participants
|
2 participants
|
9 participants
|
8 participants
|
|
Patient Self-reported Perceived Health Status
Poor
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CDSMP
n=46 Participants
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
n=11 Participants
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
n=20 Participants
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
n=30 Participants
Usual Care
|
|---|---|---|---|---|
|
Diabetes-related Behaviors
Space carbohydrates
|
0.15 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.00
|
-0.36 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.67
|
0.60 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.58
|
0.64 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.28
|
|
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
|
0 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 0.63
|
0 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.68
|
-0.66 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.02
|
|
Diabetes-related Behaviors
Followed a healthful eating plan
|
0.32 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.97
|
-0.36 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.63
|
0.50 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.37
|
0.52 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.34
|
|
Diabetes-related Behaviors
Test blood sugar
|
0.26 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.01
|
-0.91 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.12
|
0.10 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.05
|
0.97 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.76
|
|
Diabetes-related Behaviors
Test blood sugar the recommended times
|
0.55 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.37
|
-1.22 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.28
|
0.11 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.40
|
1.21 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.28
|
|
Diabetes-related Behaviors
Exercise at least 30 minutes
|
0.80 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.90
|
0.09 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.39
|
-0.16 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.22
|
0.70 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.44
|
|
Diabetes-related Behaviors
Participate in a specific exercise session
|
0 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.39
|
-1.00 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.61
|
0.37 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.89
|
0.72 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.06
|
|
Diabetes-related Behaviors
Check feet
|
1.84 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.99
|
0.36 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.11
|
0.65 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.66
|
0.63 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.11
|
|
Diabetes-related Behaviors
Wash feet
|
0.52 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.55
|
0.09 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.70
|
-0.05 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.00
|
-0.17 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.37
|
|
Diabetes-related Behaviors
Soak feet
|
0.74 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.29
|
1.00 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.00
|
0.55 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.50
|
0.32 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.13
|
|
Diabetes-related Behaviors
Dry between toes
|
0.53 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.52
|
0.36 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.91
|
1.53 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.04
|
0.76 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.67
|
|
Diabetes-related Behaviors
Inspect inside of shoes
|
1.47 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.53
|
0.82 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.89
|
0.20 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.16
|
0.11 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 3.57
|
|
Diabetes-related Behaviors
Follow healthful eating plan
|
0.28 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.05
|
-0.36 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 1.96
|
0.60 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.44
|
0.93 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.45
|
|
Diabetes-related Behaviors
Eat 5+ servings of fruits and vegetables
|
0.31 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.92
|
0.64 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.46
|
0.35 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.06
|
1.10 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.14
|
|
Diabetes-related Behaviors
Eat high-fat foods
|
-0.98 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.17
|
1.45 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.34
|
0.53 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.29
|
-0.72 Days (e.g., Avg diff 12mo vs baseline)
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
CDSMP
n=46 Participants
6-week educational classes
CDSMP : 6-week classes
|
Personal Digital Assistant (PDA)
n=11 Participants
Personal digital assistance (technological)
PDA : Technological assistance
|
PDA/CDSMP
n=20 Participants
Combined intervention
PDA/CDSMP : Combined technology and education
|
Control
n=30 Participants
Usual Care
|
|---|---|---|---|---|
|
Quality of Life (QOL)
Mental health was not good in the past 30 days
|
6.8 Number of days
Standard Deviation 9.6
|
7.2 Number of days
Standard Deviation 12.6
|
7.3 Number of days
Standard Deviation 11.0
|
6.6 Number of days
Standard Deviation 10.2
|
|
Quality of Life (QOL)
Poor phys/mental health prevented usual activities
|
3.8 Number of days
Standard Deviation 7.2
|
7.3 Number of days
Standard Deviation 12.6
|
7.8 Number of days
Standard Deviation 9.1
|
5.4 Number of days
Standard Deviation 9.3
|
|
Quality of Life (QOL)
Physical health was not good in the past 30 days
|
5.9 Number of days
Standard Deviation 8.7
|
9.0 Number of days
Standard Deviation 11.7
|
8.5 Number of days
Standard Deviation 10.2
|
7.3 Number of days
Standard Deviation 8.8
|
Adverse Events
CDSMP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personal Digital Assistant (PDA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PDA/CDSMP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place