Trial Outcomes & Findings for Empowering Patients to Better Manage Diabetes Through Self-Care (NCT NCT00254501)
NCT ID: NCT00254501
Last Updated: 2016-07-22
Results Overview
Compare changes in Hemoglobin A-1C from baseline between the two groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
baseline and 12 months
Results posted on
2016-07-22
Participant Flow
Participant milestones
| Measure |
Usual Care Plus Out-of-pocket Cost Waiver
Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
|
EMPOWER Group
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
37
|
|
Overall Study
COMPLETED
|
31
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Usual Care Plus Out-of-pocket Cost Waiver
Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
|
EMPOWER Group
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Empowering Patients to Better Manage Diabetes Through Self-Care
Baseline characteristics by cohort
| Measure |
Usual Care Plus Out-of-pocket Cost Waiver
n=31 Participants
Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
|
EMPOWER Group
n=36 Participants
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
55.6 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
54.2 years
STANDARD_DEVIATION 8.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
30 participants
n=93 Participants
|
32 participants
n=4 Participants
|
62 participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Education categories
High school graduate
|
5 participants
n=93 Participants
|
4 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Education categories
Some college
|
17 participants
n=93 Participants
|
15 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Education categories
College graduate
|
8 participants
n=93 Participants
|
11 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Education categories
At least a masters degree
|
0 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Education categories
Unspecified
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Income categories
$15 000 to <$30 000
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Income categories
$30 000 to <$50 000
|
11 participants
n=93 Participants
|
12 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Income categories
$50 000 to <$100 000
|
11 participants
n=93 Participants
|
10 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Income categories
$100 000 or more
|
2 participants
n=93 Participants
|
10 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Income categories
Unspecified
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Hypertension
Yes
|
16 participants
n=93 Participants
|
26 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Hypertension
No
|
15 participants
n=93 Participants
|
10 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Dyslipidemia
Yes
|
16 participants
n=93 Participants
|
25 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Dyslipidemia
No
|
15 participants
n=93 Participants
|
11 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Depression
Yes
|
10 participants
n=93 Participants
|
6 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Depression
No
|
21 participants
n=93 Participants
|
30 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
On glucose-lowering therapy
Yes
|
24 participants
n=93 Participants
|
28 participants
n=4 Participants
|
52 participants
n=27 Participants
|
|
On glucose-lowering therapy
No
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
On oral agents
Yes
|
20 participants
n=93 Participants
|
24 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
On oral agents
No
|
11 participants
n=93 Participants
|
12 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
On insulin
Yes
|
10 participants
n=93 Participants
|
5 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
On insulin
No
|
21 participants
n=93 Participants
|
31 participants
n=4 Participants
|
52 participants
n=27 Participants
|
|
On other diabetes medications
Yes
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
On other diabetes medications
No
|
29 participants
n=93 Participants
|
33 participants
n=4 Participants
|
62 participants
n=27 Participants
|
|
Used diabetic supplies
Yes
|
18 participants
n=93 Participants
|
10 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Used diabetic supplies
No
|
13 participants
n=93 Participants
|
26 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Years since diabetes diagnosis
|
8.0 years
STANDARD_DEVIATION 7.4 • n=93 Participants
|
9.9 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
9.0 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: Specific employers were recruited and offered waiver of out-of-pocket costs for diabetes-related care to their employees to participate in the study. The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.
Compare changes in Hemoglobin A-1C from baseline between the two groups.
Outcome measures
| Measure |
Usual Care Plus Out-of-pocket Cost Waiver
n=29 Participants
Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
|
Pharmacists Consults Plus Out-of-pocket Cost Waiver
n=36 Participants
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
|
|---|---|---|
|
Change in Hemoglobin A-1C From Baseline
|
-0.16 percentage of glycolsylated hemoglobin
Standard Deviation 0.42
|
-0.50 percentage of glycolsylated hemoglobin
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.
Changes from baseline in LDL, HDL, total cholesterol, triglycerides. Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group): 1. LDL 2. HDL 3. Total cholesterol 4. Triglycerides
Outcome measures
| Measure |
Usual Care Plus Out-of-pocket Cost Waiver
n=31 Participants
Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
|
Pharmacists Consults Plus Out-of-pocket Cost Waiver
n=36 Participants
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
|
|---|---|---|
|
Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
LDL (n: 27; 35)
|
0.1 mg/dl
Interval -8.3 to 8.5
|
-3.9 mg/dl
Interval -17.0 to 9.2
|
|
Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
Total cholesterol (n: 29; 36)
|
-5.1 mg/dl
Interval -16.5 to 6.3
|
-11.6 mg/dl
Interval -25.0 to 1.8
|
|
Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
triglycerides (n: 29; 36)
|
-5.8 mg/dl
Interval -58.3 to 46.6
|
-8.9 mg/dl
Interval -30.0 to 12.3
|
|
Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides
HDL (n: 29; 36)
|
-3.6 mg/dl
Interval -7.2 to -0.05
|
-6.3 mg/dl
Interval -9.1 to -3.4
|
SECONDARY outcome
Timeframe: baseline to 12 monthsPopulation: Changes in claims-based data from baseline to 12 months among patients with at least one diabetes-related claim at baseline.
Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are: 1. Total cost of care 2. Costs of diabetes medications 3. Costs of diabetes supplies
Outcome measures
| Measure |
Usual Care Plus Out-of-pocket Cost Waiver
n=31 Participants
Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
|
Pharmacists Consults Plus Out-of-pocket Cost Waiver
n=36 Participants
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
|
|---|---|---|
|
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
Total health care costs (n: 31; 36)
|
-89 US dollars
Interval -3355.0 to 3177.0
|
1612 US dollars
Interval -953.0 to 24176.0
|
|
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
Diabetes medication costs (n: 24; 28)
|
516 US dollars
Interval 176.0 to 857.0
|
450 US dollars
Interval 69.0 to 830.0
|
|
Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months
Diabetes supplies costs (n: 18; 10)
|
237 US dollars
Interval 59.0 to 415.0
|
191 US dollars
Interval 78.0 to 304.0
|
SECONDARY outcome
Timeframe: From baseline to 12 monthsPopulation: The number of participants reported for each outcome reflects those participants who completed both baseline and 12-month surveys.
Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group): 1. Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment 2. Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers. 3. Changes from baseline to 12 months for understanding of diabetes. This is a single question: "How would you rate your understanding of diabetes and its treatment?" which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent).
Outcome measures
| Measure |
Usual Care Plus Out-of-pocket Cost Waiver
n=31 Participants
Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
|
Pharmacists Consults Plus Out-of-pocket Cost Waiver
n=36 Participants
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
|
|---|---|---|
|
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
Overall Diabetes Empowerment Scale (n: 27; 34)
|
0.29 units on a scale
Interval 0.01 to 0.56
|
0.17 units on a scale
Interval 0.04 to 0.3
|
|
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
Adherence Starts with Knowledge (ASK-20)(n:28; 31)
|
0.25 units on a scale
Interval -0.76 to 1.26
|
-0.65 units on a scale
Interval -1.86 to 0.57
|
|
Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months
Understanding of Diabetes (n: 29; 35)
|
-0.14 units on a scale
Interval -0.4 to 0.13
|
0.54 units on a scale
Interval 0.12 to 0.96
|
Adverse Events
Usual Care Plus Out-of-pocket Cost Waiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EMPOWER Group
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