Managing Diabetes to Gain Opportunities for a More Active Life

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692208
• Other study ID #: IRB18-0425
• Secondary ID: R01DK127961-01
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: September 29, 2020

Study information

• Verified date: January 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 29, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Care Utilization	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
Primary	Documentation of Diabetes Goal	Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).	Baseline, 6 months
Secondary	Personalized A1C Goals	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.	Baseline, 6 months
Secondary	Patient Ability to Reach Personalized Goals	Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey.	Baseline, 6 month