Back to resultsNovel Digital Patient-Reported Outcomes Tool for Diabetes Management
Primary Purpose
Type 2 Diabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: PCP Group: Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and Provide care to at least five patients with a diagnosis of T2D Patient Group: Have a diagnosis of T2D for ≥6 months; Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two vi its in the past year; Fluency in English or Spanish; Be willing to send/receive text messages; and Be > 18 years of age. Exclusion Criteria: Patient Group: Refuse or are unable to provide informed consent; Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in the EHR; Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR); Are pregnant or planning to become pregnant within 12 months; Currently participate in another T2D study; or Plan to discontinue care at the clinic within the next 12 months.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
iMatter2
Usual Care (UC)
Arm Description
All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.
All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.
Outcomes
Primary Outcome Measures
Change in Hemoglobin A1C (HbA1c)
HbA1c will be extracted from home A1c kits.
Secondary Outcome Measures
Percentage of Patients Eligible for Participation in Trial who Enroll
Percentage of PCP Practices Eligible for Participation in Trial that Enroll
Percentage of Providers who View PRO Reports
Percentage of Patients who Respond to PRO Text Messages
Percentage of Patients who View PRO Interactive Dashboard
Mean Number of EHR Reports Viewed by Providers
Total Number of EHR Reports Viewed by Providers
Percentage of PRO Messages Responded To by Patients
Mean Number of PRO Messages Responded To by Patients
Total Number of PRO Messages Responded To by Patients
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard
Total Number of Reports Viewed by Patients via PRO Interactive Dashboard
Full Information
NCT ID
NCT05884775
First Posted
May 23, 2023
Last Updated
May 23, 2023
Sponsor
NYU Langone Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT05884775
Brief Title
Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
Official Title
iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
January 1, 2028 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) to evaluate the effectiveness of iMatter2 versus usual care on reduction in HbA1c at 12-months (primary outcome) among patients with Type 2 diabetes (T2D).
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
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
353 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iMatter2
Arm Type
Experimental
Arm Description
All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.
Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.
Intervention Type
Other
Intervention Name(s)
Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
Other Intervention Name(s)
iMatter2
Intervention Description
Once the program begins, the AI chatbot sends daily text messages that include the PRO questions; a link to a library of educational resources tailored to their responses and personalized motivational messages with support. Participants will also be sent links to the interactive web-based dashboard that visualizes their daily PRO and HbA1c data. PCPs will be able to view reports of patients' PRO and home A1c data through the EHR interface, which can be reviewed during visits with the patient or asynchronously to track patient PROs between visits.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1C (HbA1c)
Description
HbA1c will be extracted from home A1c kits.
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Percentage of Patients Eligible for Participation in Trial who Enroll
Time Frame
Up to Month 12
Title
Percentage of PCP Practices Eligible for Participation in Trial that Enroll
Time Frame
Up to Month 12
Title
Percentage of Providers who View PRO Reports
Time Frame
Up to Month 12
Title
Percentage of Patients who Respond to PRO Text Messages
Time Frame
Up to Month 12
Title
Percentage of Patients who View PRO Interactive Dashboard
Time Frame
Up to Month 12
Title
Mean Number of EHR Reports Viewed by Providers
Time Frame
Up to Month 12
Title
Total Number of EHR Reports Viewed by Providers
Time Frame
Up to Month 12
Title
Percentage of PRO Messages Responded To by Patients
Time Frame
Up to Month 12
Title
Mean Number of PRO Messages Responded To by Patients
Time Frame
Up to Month 12
Title
Total Number of PRO Messages Responded To by Patients
Time Frame
Up to Month 12
Title
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard
Time Frame
Up to Month 12
Title
Total Number of Reports Viewed by Patients via PRO Interactive Dashboard
Time Frame
Up to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
PCP Group:
Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and
Provide care to at least five patients with a diagnosis of T2D
Patient Group:
Have a diagnosis of T2D for ≥6 months;
Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two vi its in the past year;
Fluency in English or Spanish;
Be willing to send/receive text messages; and
Be > 18 years of age.
Exclusion Criteria:
Patient Group:
Refuse or are unable to provide informed consent;
Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in the EHR;
Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR);
Are pregnant or planning to become pregnant within 12 months;
Currently participate in another T2D study; or
Plan to discontinue care at the clinic within the next 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoinette Schoenthaler
Phone
6465013434
Email
Antoinette.schoenthaler@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Cruz
Email
Jocelyn.acosta@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette Schoenthaler
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD collected in this study will be available only to:
The research team, including the Principal Investigator, study coordinators, and personnel responsible for the support or oversight of the study
The study sponsor: The Agency for Healthcare Research and Quality
Learn more about this trial
Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
We'll reach out to this number within 24 hrs