Trial Outcomes & Findings for Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients (NCT NCT02779556)
NCT ID: NCT02779556
Last Updated: 2021-12-15
Results Overview
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
756 participants
Primary outcome timeframe
Six months
Results posted on
2021-12-15
Participant Flow
Participant milestones
| Measure |
Enhanced Usual Care
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
|
Intervention
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
|
|---|---|---|
|
Baseline
STARTED
|
394
|
362
|
|
Baseline
COMPLETED
|
393
|
362
|
|
Baseline
NOT COMPLETED
|
1
|
0
|
|
3 Months
STARTED
|
393
|
362
|
|
3 Months
COMPLETED
|
326
|
314
|
|
3 Months
NOT COMPLETED
|
67
|
48
|
|
6 Month
STARTED
|
353
|
333
|
|
6 Month
COMPLETED
|
320
|
294
|
|
6 Month
NOT COMPLETED
|
33
|
39
|
|
6 Month HbA1c
STARTED
|
394
|
362
|
|
6 Month HbA1c
COMPLETED
|
325
|
312
|
|
6 Month HbA1c
NOT COMPLETED
|
69
|
50
|
|
12 Month HbA1c
STARTED
|
394
|
362
|
|
12 Month HbA1c
COMPLETED
|
256
|
260
|
|
12 Month HbA1c
NOT COMPLETED
|
138
|
102
|
Reasons for withdrawal
| Measure |
Enhanced Usual Care
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
|
Intervention
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
|
|---|---|---|
|
Baseline
Partial baseline interview completed
|
1
|
0
|
|
3 Months
Lost to Follow-up
|
40
|
29
|
|
3 Months
Missed 3 month clinic visit
|
27
|
19
|
|
6 Month
Lost to Follow-up
|
33
|
39
|
|
6 Month HbA1c
No value collected during window
|
69
|
50
|
|
12 Month HbA1c
No value collected during window
|
138
|
102
|
Baseline Characteristics
Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=394 Participants
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
|
Intervention
n=362 Participants
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
|
Total
n=756 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
510 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
388 Participants
n=5 Participants
|
353 Participants
n=7 Participants
|
741 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
220 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
Less than High School
|
87 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Education
High School Graduate
|
141 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Education
Some College
|
126 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Education
College Graduate
|
40 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Education
Refused to answer question
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Literacy (NVS)
Limited
|
210 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Health Literacy (NVS)
Adequate
|
184 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: 119 individuals were excluded from analysis, because they did not have a 6 month HbA1c value within the designated window.
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Outcome measures
| Measure |
Enhanced Usual Care
n=325 Participants
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
|
Intervention
n=312 Participants
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
|
|---|---|---|
|
Hemoglobin A1C (HbA1C)
|
8.4 Percentage of glycated hemoglobin
Interval 8.3 to 8.6
|
8.3 Percentage of glycated hemoglobin
Interval 8.1 to 8.5
|
PRIMARY outcome
Timeframe: Twelve monthsPopulation: 240 individuals were excluded from analysis, because they did not have a 12 month HbA1c value within the designated window.
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Outcome measures
| Measure |
Enhanced Usual Care
n=260 Participants
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
|
Intervention
n=256 Participants
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
|
|---|---|---|
|
Hemoglobin A1C (HbA1C)
|
8.5 Percentage of glycated hemoglobin
Interval 8.3 to 8.7
|
8.4 Percentage of glycated hemoglobin
Interval 8.2 to 8.6
|
SECONDARY outcome
Timeframe: Three monthsPopulation: 116 participants were excluded, missed 3 month visit.
A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.
Outcome measures
| Measure |
Enhanced Usual Care
n=326 Participants
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
|
Intervention
n=314 Participants
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
|
|---|---|---|
|
Diabetes Knowledge
|
9.2 Score on a scale
Interval 9.0 to 9.4
|
9.3 Score on a scale
Interval 9.1 to 9.5
|
SECONDARY outcome
Timeframe: Six monthsPopulation: 142 participants were excluded, missed 6 month visit.
A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.
Outcome measures
| Measure |
Enhanced Usual Care
n=320 Participants
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook
|
Intervention
n=294 Participants
ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide
|
|---|---|---|
|
Diabetes Knowledge (0-13)
|
9.5 Score on a scale
Interval 9.3 to 9.6
|
9.7 Score on a scale
Interval 9.5 to 9.9
|
Adverse Events
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kristie Hadden, PhD/Associate Professor
University of Arkansas for Medical Sciences
Phone: 501-993-3178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place