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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

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

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

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 months

Population: 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

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 months

Population: 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

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 month

Population: 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

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 year

We 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 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. Elbert Huang

The University of Chicago

Phone: (773) 834-9143

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place