Managing Diabetes to Gain Opportunities for a More Active Life

• ClinicalTrials.gov Identifier: NCT03692208
• Recruitment Status: Completed
• First Posted: October 2, 2018
• Last Update Posted: March 11, 2022
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: My Diabetes Goal Survey and Optional Care Management	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL)
• Actual Study Start Date: October 29, 2018
• Actual Primary Completion Date: August 12, 2020
• Actual Study Completion Date: September 29, 2020

Arms and Interventions

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.	Behavioral: My Diabetes Goal Survey and Optional Care Management; 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.	Behavioral: My Diabetes Goal Survey and Optional Care Management; The intervention is already described in the intervention arm description.

Outcome Measures

Primary Outcome Measures :

1. Documentation of Diabetes Goal [ Time Frame: 1 year ]
   Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).

Secondary Outcome Measures :

1. Patient selection of personalized goals [ Time Frame: 1 year ]
   Patients will receive a pre-and post-survey in which they will be asked if they have diabetes care goals. We will measure these goals over time.
2. Patient ability to reach personalized goals [ Time Frame: 1year ]
   Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey.

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Investigators

• Principal Investigator: Elbert S Huang, MD; University of Chicago

  Study Documents (Full-Text)

Documents provided by University of Chicago:

Study Protocol and Statistical Analysis Plan  [PDF] July 9, 2018

More Information

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT03692208
• Other Study ID Numbers: IRB18-0425
• First Posted: October 2, 2018
• Last Update Posted: March 11, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Chicago:

Geriatrics

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases