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Managing Diabetes to Gain Opportunities for a More Active Life

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Diabetes Goal Survey and Optional Care Management
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Geriatrics

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Delayed Intervention/Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Documentation of Diabetes Goal
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 20, 2018
Last Updated
January 25, 2023
Sponsor
University of Chicago
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03692208
Brief Title
Managing Diabetes to Gain Opportunities for a More Active Life
Official Title
Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
August 12, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Geriatrics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Intervention/Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
My Diabetes Goal Survey and Optional Care Management
Intervention Description
The intervention is already described in the intervention arm description.
Primary Outcome Measure Information:
Title
Documentation of Diabetes Goal
Description
Documentation of a personalized goal for diabetes care (e.g., A1C target) of diabetes care (yes or no).
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Personalized A1C Goals
Description
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.
Time Frame
Baseline, 6 months
Title
Patient Ability to Reach Personalized Goals
Description
Using EHR data, we will measure whether or not patients are reaching the goals they have documented in the survey.
Time Frame
Baseline, 6 month
Other Pre-specified Outcome Measures:
Title
Health Care Utilization
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elbert S Huang, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Managing Diabetes to Gain Opportunities for a More Active Life

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