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Care Companion Diabetes

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated health education using a digital health pathway
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swedish Covenant HospitalRecruiting
  • NorthShore University HealthSystem Evanston HospitalRecruiting
  • NorthShore University HealthSystem Glenbrook HospitalRecruiting
  • NorthShore University HealthSystem HighlandPark HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

New diagnosis of diabetes control group

New diagnosis of diabetes intervention group

Uncontrolled diabetes control group

Uncontrolled diabetes intervention group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2022
Last Updated
September 16, 2022
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT05548218
Brief Title
Care Companion Diabetes
Official Title
Care Companion: A Pragmatic Trial Conducting Automated Health Educations Among Patient With Type-2 Diabetes Utilizing a Digital Health Pathway
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New diagnosis of diabetes control group
Arm Type
No Intervention
Arm Title
New diagnosis of diabetes intervention group
Arm Type
Experimental
Arm Title
Uncontrolled diabetes control group
Arm Type
No Intervention
Arm Title
Uncontrolled diabetes intervention group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Automated health education using a digital health pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in A1C level
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nirav Shah, MD, MPH
Phone
847-657-5959
Email
Nshah2@northshore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Ning Chi, MBBS, MPH
Phone
9175801280
Email
wchi@northshore.org
Facility Information:
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirav Shah, MD, MPH
Phone
847-657-5959
Email
NSHAH2@NORTHSHORE.ORG
Facility Name
NorthShore University HealthSystem Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirav S Shah, MD, MPH
Phone
847-570-4208
Email
nshah2@northshore.org
Facility Name
NorthShore University HealthSystem Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirav S Shah
Phone
847-570-4208
Email
nshah2@northshore.org
Facility Name
NorthShore University HealthSystem HighlandPark Hospital
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035-2558
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirav S Shah
Phone
847-570-1700
Email
nshah2@northshore.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Care Companion Diabetes

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