Managing Diabetes to Gain Opportunities for a More Active Life

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 20, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

February 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.
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.

Descriptive Information

Brief Title ^ICMJE

Managing Diabetes to Gain Opportunities for a More Active Life

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

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.
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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 2020

Estimated Primary Completion Date

February 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

65 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Elbert S Huang, MD University of Chicago

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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