Trial Outcomes & Findings for Point-of-care Health Literacy and Activation Information to Improve Diabetes Care (NCT NCT01876485)
NCT ID: NCT01876485
Last Updated: 2019-06-19
Results Overview
Measures of HbA1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
HbA1c levels will be measured at baseline, four months, and ten months.
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Arm 1: Empowering Patients in Chronic Care (EPIC)
Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
|
Arm 2: Enhanced Usual Care (EUC)
The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the Patient Aligned Care Team (PACT) Registered Nurse (RN) Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
140
|
|
Overall Study
Post-Intervention
|
125
|
129
|
|
Overall Study
Maintenance
|
116
|
114
|
|
Overall Study
COMPLETED
|
116
|
114
|
|
Overall Study
NOT COMPLETED
|
24
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
Baseline characteristics by cohort
| Measure |
Arm 1: Empowering Patients in Chronic Care (EPIC)
n=140 Participants
Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
|
Arm 2: Enhanced Usual Care (EUC)
n=140 Participants
The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
|
Total
n=280 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
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
94 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Age, Continuous
|
67.39 Years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
66.94 Years
STANDARD_DEVIATION 8.34 • n=7 Participants
|
67.17 Years
STANDARD_DEVIATION 8.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Percent Glycosylated Hemoglobin (HbA1c)
|
9.11 Percent/DCCT
STANDARD_DEVIATION 1.60 • n=5 Participants
|
9.06 Percent/DCCT
STANDARD_DEVIATION 1.32 • n=7 Participants
|
9.08 Percent/DCCT
STANDARD_DEVIATION 1.46 • n=5 Participants
|
|
Diabetes Distress Scale (DDS)
|
2.41 Units on a scale
STANDARD_DEVIATION 1.05 • n=5 Participants
|
2.45 Units on a scale
STANDARD_DEVIATION 1.02 • n=7 Participants
|
2.43 Units on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: HbA1c levels will be measured at baseline, four months, and ten months.Population: Although not all of the 140 per group with HbA1c at baseline completed each the post-intervention and maintenance assessments, intent to treat analyses were conducted which enabled us to use the full 140 across time points.
Measures of HbA1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.
Outcome measures
| Measure |
Arm 1: Empowering Patients in Chronic Care (EPIC)
n=140 Participants
Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
|
Arm 2: Enhanced Usual Care (EUC)
n=140 Participants
The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
|
|---|---|---|
|
Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention
Baseline
|
9.11 Percentage/DCCT
Standard Deviation 1.60
|
9.06 Percentage/DCCT
Standard Deviation 1.32
|
|
Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention
4 Months
|
8.61 Percentage/DCCT
Standard Deviation 1.27
|
9.04 Percentage/DCCT
Standard Deviation 1.70
|
|
Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention
10 Months
|
8.68 Percentage/DCCT
Standard Deviation 1.53
|
8.79 Percentage/DCCT
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: Diabetes specific quality of life will be measured at baseline, four months, and ten months.Population: Seven participants did not complete the DDS at baseline. Therefore, sample sizes for DDS are lower than for HbA1c. Although not all of the 138/135 per group with DDS at baseline completed each the post-intervention and maintenance assessments, intent to treat analyses were conducted which enabled us to use the full number across time points.
The Diabetes Distress Scale (DDS) will be used to assess diabetes quality of life throughout the study. Minimum value: 1; Maximum value: 6. Higher scores indicate a higher level of diabetes distress.
Outcome measures
| Measure |
Arm 1: Empowering Patients in Chronic Care (EPIC)
n=138 Participants
Patients in the intervention arm will receive the Empowering Patients in Chronic Care group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
Empowering Patients in Chronic Care (EPIC): EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
|
Arm 2: Enhanced Usual Care (EUC)
n=135 Participants
The Enhanced Usual Care (EUC) arm will serve as a concurrent control group to compare to the intervention arm of the study. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
Enhanced Usual Care (EUC): Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
|
|---|---|---|
|
Change in Diabetes Specific Quality of Life
Baseline
|
2.41 Units On A Scale
Standard Deviation 1.05
|
2.45 Units On A Scale
Standard Deviation 1.02
|
|
Change in Diabetes Specific Quality of Life
4 Months
|
2.02 Units On A Scale
Standard Deviation 0.81
|
2.30 Units On A Scale
Standard Deviation 0.99
|
|
Change in Diabetes Specific Quality of Life
10 Months
|
1.96 Units On A Scale
Standard Deviation 0.76
|
2.27 Units On A Scale
Standard Deviation 1.05
|
Adverse Events
Arm 1: Empowering Patients in Chronic Care (EPIC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Enhanced Usual Care (EUC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 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