Trial Outcomes & Findings for Managing Diabetes to Gain Opportunities for a More Active Life (NCT NCT03692208)
NCT ID: NCT03692208
Last Updated: 2023-02-21
Results Overview
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).
COMPLETED
NA
110 participants
Baseline, 6 months
2023-02-21
Participant Flow
110 Participants were randomized to either intervention or delayed intervention, but only 75 participants completed the initial survey immediately after randomization that was a required element to participate in the study.
Participant milestones
| Measure |
Intervention
Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart.
|
Delayed Intervention/Control
Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above.
My Diabetes Goal Survey and Optional Care Management: The intervention is already described in the intervention arm description.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
|
Overall Study
Received Allocated Intervention
|
42
|
33
|
|
Overall Study
Follow-Up Survey
|
41
|
25
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There are missing baseline A1C values for both study arms.
Baseline characteristics by cohort
| Measure |
Intervention
n=50 Participants
Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart.
|
Delayed Intervention
n=50 Participants
Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated above.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=50 Participants
|
50 Participants
n=50 Participants
|
100 Participants
n=100 Participants
|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 5.0 • n=50 Participants
|
72.7 years
STANDARD_DEVIATION 5.5 • n=50 Participants
|
72.5 years
STANDARD_DEVIATION 5.2 • n=100 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=50 Participants
|
39 Participants
n=50 Participants
|
68 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
32 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=50 Participants
|
49 Participants
n=50 Participants
|
97 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=50 Participants
|
39 Participants
n=50 Participants
|
70 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
25 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
A1c
|
7.1 % (percentage of A1c)
STANDARD_DEVIATION 0.8 • n=42 Participants • There are missing baseline A1C values for both study arms.
|
7.2 % (percentage of A1c)
STANDARD_DEVIATION 1.3 • n=46 Participants • There are missing baseline A1C values for both study arms.
|
7.1 % (percentage of A1c)
STANDARD_DEVIATION 1.1 • n=88 Participants • There are missing baseline A1C values for both study arms.
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: We reviewed the electronic health records to assess how many participants of the total sample of 100 participants had a documented goal in the EHR at baseline and at months.
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).
Outcome measures
| Measure |
Intervention Arm
n=50 Participants
Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart.
|
Delayed Intervention Arm
n=50 Participants
Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated.
|
|---|---|---|
|
Documentation of Diabetes Goal
Baseline · Documentation of Goals
|
21 Participants
|
27 Participants
|
|
Documentation of Diabetes Goal
Baseline · No Documentation of Goals
|
29 Participants
|
23 Participants
|
|
Documentation of Diabetes Goal
6-month Trial · Documentation of Goals
|
45 Participants
|
22 Participants
|
|
Documentation of Diabetes Goal
6-month Trial · No Documentation of Goals
|
5 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: The number of participants analyzed is less than 50 because of incomplete collection of personalized A1c goals at the 6 month timepoint.
The A1C goal outcome is based on a survey response and is distinct from the measured A1C from laboratory testing. The number of analyzed A1C goal results is therefore dependent on the number of survey respondents.
Outcome measures
| Measure |
Intervention Arm
n=35 Participants
Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart.
|
Delayed Intervention Arm
n=28 Participants
Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated.
|
|---|---|---|
|
Personalized A1C Goals
Baseline
|
6.6 % (percentage A1c)
Standard Deviation 0.7
|
6.9 % (percentage A1c)
Standard Deviation 1.6
|
|
Personalized A1C Goals
6 months
|
7.0 % (percentage A1c)
Standard Deviation 0.9
|
6.7 % (percentage A1c)
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, 6 monthPopulation: We reviewed the electronic health records to assess how many participants of the Intervention Arm reached their documented goals at baseline and at 6 months. The denominator is limited to participants with survey responses and lab values.
Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey.
Outcome measures
| Measure |
Intervention Arm
n=32 Participants
Patients that are enrolled in the intervention arm will receive an email message via MyChart (University of Chicago patient portal) to complete an initial questionnaire. Completion of the questionnaire will be required prior to initiating risk factor tracking and opening the portal to requests for care management support. A study team member (diabetes nurse educator) will contact the patient, if requested via the survey, to initiate telephonic care management or links to additional support services. Upon completion the study, all patients will receive a post-survey via MyChart.
|
Delayed Intervention Arm
n=25 Participants
Patients enrolled in the delayed intervention arm will receive usual care for the first 6 months, and then will receive the survey and intervention as stated.
|
|---|---|---|
|
Patient Ability to Reach Personalized Goals
Baseline · Achieved Goal
|
10 Participants
|
10 Participants
|
|
Patient Ability to Reach Personalized Goals
Baseline · Goal not achieved
|
22 Participants
|
15 Participants
|
|
Patient Ability to Reach Personalized Goals
6 month trial · Achieved Goal
|
13 Participants
|
5 Participants
|
|
Patient Ability to Reach Personalized Goals
6 month trial · Goal not achieved
|
17 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearWe will utilize the EHR to determine the frequency of referrals to telephone care management, the source of referrals (population management, physician), the patient predictors of referrals, and to characterize frequency and content of telephonic management.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Arm
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