Care Companion Diabetes

Sponsor
NorthShore University HealthSystem (Other)
Overall Status
Recruiting
CT.gov ID
NCT05548218
Collaborator
(none)
220
4
4
12
55
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Automated health education using a digital health pathway
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Care Companion: A Pragmatic Trial Conducting Automated Health Educations Among Patient With Type-2 Diabetes Utilizing a Digital Health Pathway
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Aug 15, 2023
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: New diagnosis of diabetes control group

Experimental: New diagnosis of diabetes intervention group

Other: Automated health education using a digital health pathway
MyChart Care Companion is an interactive, individualized plan of care delivered to at-risk patients through user-friendly, accessible technology. Care Companion is a digital health pathway housed within EPIC. Care Companion features are integrated into the existing MyChart mobile app, which is part of Epic, and is available for iOS and Android devices. The interactive plan of care delivers notifications to patients' phones, prompts patients to complete educational session in the mobile app, analyzes questionnaire responses and patient-reported data, and orchestrates changes to the plan and escalations as needed to help patients, their caregivers, and care managers stay on top of the patient care. In addition to mobile phone, patients can also now access MyChart Care Companion on webpages via computers. The automated pathway assigns patient interactive health education materials during the study.

No Intervention: Uncontrolled diabetes control group

Experimental: Uncontrolled diabetes intervention group

Other: Automated health education using a digital health pathway
MyChart Care Companion is an interactive, individualized plan of care delivered to at-risk patients through user-friendly, accessible technology. Care Companion is a digital health pathway housed within EPIC. Care Companion features are integrated into the existing MyChart mobile app, which is part of Epic, and is available for iOS and Android devices. The interactive plan of care delivers notifications to patients' phones, prompts patients to complete educational session in the mobile app, analyzes questionnaire responses and patient-reported data, and orchestrates changes to the plan and escalations as needed to help patients, their caregivers, and care managers stay on top of the patient care. In addition to mobile phone, patients can also now access MyChart Care Companion on webpages via computers. The automated pathway assigns patient interactive health education materials during the study.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Swedish Covenant Hospital Chicago Illinois United States 60625
2 NorthShore University HealthSystem Evanston Hospital Evanston Illinois United States 60201
3 NorthShore University HealthSystem Glenbrook Hospital Glenview Illinois United States 60201
4 NorthShore University HealthSystem HighlandPark Hospital Highland Park Illinois United States 60035-2558

Sponsors and Collaborators

  • NorthShore University HealthSystem

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nirav Shah, Medical Director of Quality Innovation and Clinical Practice Analytics, NorthShore University HealthSystem
ClinicalTrials.gov Identifier:
NCT05548218
Other Study ID Numbers:
  • EH22-331
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022