NCT05548218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

September 16, 2022

Last Update Submit

April 22, 2024

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in A1C level

    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.

    16 weeks

Study Arms (4)

New diagnosis of diabetes control group

NO INTERVENTION

New diagnosis of diabetes intervention group

EXPERIMENTAL
Other: Automated health education using a digital health pathway

Uncontrolled diabetes control group

NO INTERVENTION

Uncontrolled diabetes intervention group

EXPERIMENTAL
Other: Automated health education using a digital health pathway

Interventions

Automated health education using a digital health pathwayOTHER

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.

New diagnosis of diabetes intervention groupUncontrolled diabetes intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

NorthShore University HealthSystem Evanston Hospital

Evanston, Illinois, 60201, United States

Location

NorthShore University HealthSystem Glenbrook Hospital

Glenview, Illinois, 60201, United States

Location

NorthShore University HealthSystem HighlandPark Hospital

Highland Park, Illinois, 60035-2558, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Quality Innovation and Clinical Practice Analytics

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

August 15, 2022

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)