Trial Outcomes & Findings for Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes (NCT NCT01855399)
NCT ID: NCT01855399
Last Updated: 2019-07-12
Results Overview
Percent glycosylated hemoglobin is measured at baseline, 6 months, and 12 months to test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer support alone.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
290 participants
Primary outcome timeframe
6 Month
Results posted on
2019-07-12
Participant Flow
Participant milestones
| Measure |
Coaching With Decision Aid-TEC
All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data.
The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches will call their assigned peers once a week to provide support for their action steps.
|
Coaching Without the Decision Aid- Print Materials
Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach to review usual print diabetes education materials.
The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps.
|
|---|---|---|
|
6 Month
STARTED
|
146
|
144
|
|
6 Month
COMPLETED
|
126
|
129
|
|
6 Month
NOT COMPLETED
|
20
|
15
|
|
12 Month
STARTED
|
126
|
129
|
|
12 Month
COMPLETED
|
119
|
118
|
|
12 Month
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
Coaching With Decision Aid-TEC
All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data.
The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches will call their assigned peers once a week to provide support for their action steps.
|
Coaching Without the Decision Aid- Print Materials
Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach to review usual print diabetes education materials.
The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps.
|
|---|---|---|
|
6 Month
Lost to Follow-up
|
12
|
9
|
|
6 Month
Withdrawal by Subject
|
8
|
6
|
|
12 Month
Lost to Follow-up
|
7
|
11
|
Baseline Characteristics
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
Baseline characteristics by cohort
| Measure |
Coaching With Decision Aid-TEC
n=146 Participants
All participants will be assigned to one of up to 87 peer coaches, who also are Detroit VA diabetes patients who previously had poor glycemic control but are currently in good control. After their baseline assessment, participants in both arms will receive information on their lab and blood pressure values and will be randomized to one of the two study arms. Participants in the TEC arm will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data.
The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches will call their assigned peers once a week to provide support for their action steps.
|
Coaching Without the Decision Aid- Print Materials
n=144 Participants
Participants randomized to the 'print materials' group will be scheduled for an initial visit with their coach to review usual print diabetes education materials.
The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months coaches in both arms will call their assigned peers once a week to provide support for their action steps.
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
92 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
percent glycosylated hemoglobin
|
9.1 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.7 • n=5 Participants
|
9.1 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.7 • n=7 Participants
|
9.1 percent glycosylated hemoglobin
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthPercent glycosylated hemoglobin is measured at baseline, 6 months, and 12 months to test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer support alone.
Outcome measures
| Measure |
Peer Coaching + Decision Aid
n=121 Participants
All participants will be assigned to a peer coaches, who also is a Detroit VA diabetes patients who previously had poor glycemic control but is currently in good control. After their baseline assessment, participants will receive information on their lab and blood pressure values and will be scheduled for an initial visit with their coach to review the decision aid, which has incorporated their personal baseline data. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps.
|
Peer Coaching Alone
n=122 Participants
Participants will be scheduled for an initial visit with their coach to review usual print diabetes education materials. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps.
|
|---|---|---|
|
Percent Glycosylated Hemoglobin
|
8.38 Percent glycosylated hemoglobin
Standard Deviation 1.7
|
8.39 Percent glycosylated hemoglobin
Standard Deviation 1.7
|
Adverse Events
Coaching With Decision Aid-TEC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coaching Without the Decision Aid- Print Materials
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
Dr. Michele Heisler
VA HSRD: CCMR Ann Arbor and University of Michigan Medical School
Phone: (734) 845-3614
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place