Care Companion Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Automated health education using a digital health pathway

• Registration Number: NCT05548218
• Lead Sponsor: NorthShore University HealthSystem

Brief Summary

Digital health interventions have the potential to help patients with diabetes effectively manage their disease at home. Many digital health studies provide patients with educational materials and self-care recommendations. The digital health interventions allow patients to conveniently access these materials on their phones or computers, and enable care teams to provide essential knowledge for diabetes management. Digital health based education intervention is a reasonably inexpensive method that offers high coverage and motivational encouragement to help patients improve their health at home.This study aims to provide patients with timely education for diabetes management and has the potential to improve clinical outcomes for patients with diabetes.

Detailed Description

This study is a prospective, randomized control, pragmatic trial of patients with diabetes, including patients newly diagnosed with diabetes and patients with uncontrolled diabetes. This study focuses on delivering educational materials through the MyChart Care Companion pathway to conduct timely educations and assess patient medication adherence level and activity level. This is a minimal risk study without intervention procedures.

There are two Type 2 Diabetes subjects groups uncontrolled diabetes and new diabetics. Each group will be randomized 1 to 1 to either the Care Companion program or control group which receives a one-page document on diabetic care. The Care Companion program is a digital interactive weekly program that includes modules on health and nutrition education and weekly activity and medication adherence check-ins. There are weekly modules that are completed over 16 weeks.

The objective is to provide timely education to patients with type 2 diabetes through MyChart Care Companion pathway, with the aim of improving patient's self management knowledge. We will also evaluate patient experience and acceptance of the MyChart Care Companion features.

Study Timeline

• Study Start: 2022-08-15
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patients with a new type 2 diabetes diagnosis within 1 year at time of enrollment and has an A1c level over 6.5%, or patients with a type 2 diabetes diagnosis over an year and has an A1c level over 8% at time of enrollment
• Patient able to speak and understand English
• Patient is at least 18 years of age

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Exclusion Criteria

• Patient has cognitive limitations that, in the opinion of their provider, limit the patient's ability to understand study requirements

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New diagnosis of diabetes intervention group	Automated health education using a digital health pathway	-
Uncontrolled diabetes intervention group	Automated health education using a digital health pathway	-

Primary Outcome Measures

Name	Time	Method
Change in A1C level	16 weeks	Our primary clinical outcome of interest would be the change in A1c levels measured at baseline during enrollment and at the 12-16 week mark of the study.

Trial Locations

Locations (4)

NorthShore University HealthSystem Glenbrook Hospital; 🇺🇸 Glenview, Illinois, United States

NorthShore University HealthSystem Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

Swedish Covenant Hospital; 🇺🇸 Chicago, Illinois, United States

NorthShore University HealthSystem HighlandPark Hospital; 🇺🇸 Highland Park, Illinois, United States