Type 2 DiabetesNCT05548218
Care Companion Diabetes
A study testing Automated health education using a digital health pathway in people with Type 2 Diabetes, run by Endeavor Health at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Automated health education using a digital health pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Aug 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient has cognitive limitations that, in the opinion of their provider, limit the patient's ability to understand study requirements
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Swedish Covenant Hospital
Chicago, Illinois, 60625
NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, 60201
NorthShore University HealthSystem Glenbrook Hospital
Glenview, Illinois, 60201
NorthShore University HealthSystem HighlandPark Hospital
Highland Park, Illinois, 60035-2558
About this study
Official title: Care Companion: A Pragmatic Trial Conducting Automated Health Educations Among Patient With Type-2 Diabetes Utilizing a Digital Health Pathway
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Automated health education using a digital health pathway
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| New diagnosis of diabetes control group | No intervention | Not described |
| New diagnosis of diabetes intervention group | Experimental | Not described Receives: Other: Automated health education using a digital health pathway |
| Uncontrolled diabetes control group | No intervention | Not described |
| Uncontrolled diabetes intervention group | Experimental | Not described Receives: Other: Automated health education using a digital health pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start15 Aug 2022
- Primary completion15 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav Shah, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548218
- Sponsor's protocol ID
- EH22-331
- Status last verified
- Apr 2024
- First submitted
- 16 Sep 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Companion: A Pragmatic Trial Conducting Automated Health Educations Among Patient With Type-2 Diabetes Utilizing a Digital Health Pathway
- ClinicalTrials.gov ID
- NCT05548218
- Acronym / sponsor ID
- EH22-331
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient has cognitive limitations that, in the opinion of their provider, limit the patient's ability to understand study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated health education using a digital health pathwayMyChart 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. | Other | New diagnosis of diabetes intervention group, Uncontrolled diabetes intervention group |
Primary outcome
Change in A1C level
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated health education using a digital health pathway in people with Type 2 Diabetes, run by Endeavor Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1C level (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.