- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692208
Managing Diabetes to Gain Opportunities for a More Active Life
January 25, 2023 updated by: University of Chicago
Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL)
The purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this novel patient-facing disease management intervention, My Diabetes GOAL, is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management by: 1) establishing personalized goals of care based on comorbidities and preferences, 2) tracking diabetes measures against personalized goals, and 3) selecting the route and intensity of care management to help patients achieve their goals (e.g., telephonic care management, in-person care management, and self-care resources).
This application can be used to individualize care, increase engagement with patient portals, and improve patient self-efficacy, as they take a more active role in their care.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 65 years and older
- Diagnosis of Type 2 Diabetes
- Enrolled in MyChart (University of Chicago Patient Portal)
- Outpatient clinic visit in the prior year
Exclusion Criteria:
- Under 64 years of age
- No type 2 diabetes
- Not enrolled in MyChart
- No outpatient clinic visit in the prior year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
The intervention is already described in the intervention arm description.
|
Active Comparator: 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.
|
The intervention is already described in the intervention arm description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Documentation of Diabetes Goal
Time Frame: Baseline, 6 months
|
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).
|
Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personalized A1C Goals
Time Frame: Baseline, 6 months
|
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.
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Baseline, 6 months
|
Patient Ability to Reach Personalized Goals
Time Frame: Baseline, 6 month
|
Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey.
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Baseline, 6 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Care Utilization
Time Frame: 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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elbert S Huang, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2018
Primary Completion (Actual)
August 12, 2020
Study Completion (Actual)
September 29, 2020
Study Registration Dates
First Submitted
September 20, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Estimate)
February 20, 2023
Last Update Submitted That Met QC Criteria
January 25, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB18-0425
- R01DK127961-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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