Managing Diabetes to Gain Opportunities for a More Active Life

NCT ID: NCT03692208

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2020-09-29

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

My Diabetes Goal Survey and Optional Care Management

Intervention Type: BEHAVIORAL

The intervention is already described in the intervention arm description.

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.

Group Type: ACTIVE_COMPARATOR

My Diabetes Goal Survey and Optional Care Management

Intervention Type: BEHAVIORAL

The intervention is already described in the intervention arm description.

Interventions

My Diabetes Goal Survey and Optional Care Management

The intervention is already described in the intervention arm description.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elbert S Huang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

References

Zhu M, Cui M, Nathan AG, Press VG, Wan W, Miles C, Ali R, Pusinelli M, Huisingh-Scheetz M, Huang ES. A nurse driven care management program to engage older diabetes patients in personalized goal setting and disease management. Health Sci Rep. 2024 Jun 23;7(6):e2208. doi: 10.1002/hsr2.2208. eCollection 2024 Jun.

Reference Type: DERIVED

PMID: 38915356 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK127961-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB18-0425

Identifier Type: -

Identifier Source: org_study_id