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T1DTechCHW: Enhancing the Community Health Worker Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups (T1DTechCHW)

Primary Purpose

Diabetes, Type 1 Diabetes, Young Adult

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T1D-CATCH
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T1D duration ≥6 months
  • 18-30 years old
  • Self-identified URM status: non-Hispanic Black or Hispanic
  • English- or Spanish-speaking
  • Not currently on diabetes technology (includes never offered, discontinued, or previously refused technology)

Exclusion Criteria:

  • Developmental or sensory disability interfering with study participation
  • Current pregnancy
  • Participation in another behavioral or technology intervention study in the past 6 months.

Sites / Locations

  • Albert Einstein College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

T1D-CATCH

Usual Care Control Condition

Arm Description

The CHW intervention will consist of both individual and optional group sessions with YA-URMs with T1D. In individual sessions, CHWs will provide T1D technology education, peer support, and social needs management. Over the 9-month study period, session frequency will involve weekly individual sessions based on participant technology milestones and an optional monthly CHW-led peer group support session. CHW individual and group sessions will be held via videoconferencing or in person, per participant preference and institutional COVID-19 rules.

Control arm participants will receive usual primary or endocrine care at Montefiore. Usual care consists of a physician or nurse practitioner visit with review of blood sugars and treatment decisions based on provider experience. Physicians in endocrinology practices are nested within a diabetes center with access to diabetes nurse practitioners/educators, dieticians, a psychologist, and nurses. In all practices, patients are recommended to see their physician or nurse practitioner every 3 months and attend individual or group sessions.

Outcomes

Primary Outcome Measures

Technology Use
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)

Secondary Outcome Measures

YA-URM Autonomy/ Competence, Social Support
Measured using the Healthcare Self-Determination survey
YA-URM Autonomy/ Competence, Social Support
Measured using the Healthcare Self-Determination survey
YA-URM Autonomy/ Competence, Social Support
Measured using the Healthcare Self-Determination survey
YA-URM Autonomy/ Competence, Social Support
Measured using the Healthcare Self-Determination survey
Hemoglobin A1c
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Hemoglobin A1c
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Hemoglobin A1c
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Hemoglobin A1c
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Quality of Life (Diabetes Distress)
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
Quality of Life (Diabetes Distress)
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
Quality of Life (Diabetes Distress)
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
Quality of Life (Diabetes Distress)
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
Quality of Life (Diabetes Distress)
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
Quality of Life (Diabetes Distress)
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
Quality of Life (Diabetes Distress)
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
Quality of Life (Diabetes Distress)
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
Quality of Life (Diabetes Distress
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
Quality of Life (Diabetes Distress)
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
Quality of life (Diabetes Distress)
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
Quality of Life (Diabetes Distress)
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
Technology Use
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
Technology Use
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
Technology Use
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)

Full Information

First Posted
December 16, 2021
Last Updated
September 29, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05211869
Brief Title
T1DTechCHW: Enhancing the Community Health Worker Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups
Acronym
T1DTechCHW
Official Title
T1DTechCHW: Enhancing the Community Health Worker (CHW) Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups (YA-URMs) With Type 1 Diabetes (T1D)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
The objective of this study is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1D-CATCH) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (YA-URMs) with type 1 diabetes (T1D). The investigators will conduct a 9-month randomized controlled trial in which YA-URMs will be randomized toT1D-CATCH or usual care. The investigators will recruit from adult and pediatric endocrinology and primary care practices in a large safety-net health system in the Bronx, New York. Our specific aims are to 1) evaluate T1D-CATCH effects on technology initiation and continued use over 6 months and 2) evaluate T1D-CATCH implementation using Proctor's Taxonomy of Implementation Outcomes: feasibility, adoption, fidelity, and cost.
Detailed Description
The study will involve a 9-month randomized control trial of usual care versus T1D-CATCH, an intervention that enhances core community health worker (CHW) service roles to support increased use of T1D technology in young adults (underrepresented minorities)(YA_URM's). Participants will be recruited from primary and specialty care practices at Montefiore Medical Center in the Bronx, NY, which is a large safety-net hospital system in one of the poorest counties in the U.S. Two young adult-aged CHWs from the Montefiore CHW program will be trained extensively per our Supporting Emerging Adults with Diabetes (SEAD) program manuals. For YA-URMs, CHWs will conduct hands-on diabetes technology education, goal-setting, peer support, and social service linkage. CHWs will also help shift insurance approval tasks away from busy providers and better align patient-provider priorities through close communication between the YA-URM and provider. Group sessions will be optional and will follow the YA-centric education curriculum developed in Dr. Agarwal's Supporting Emerging Adults with Diabetes (SEAD) program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 1 Diabetes, Young Adult, Diabetes Mellitus

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will be randomized after enrollment into the study using REDCap. Study staff will notify CHWs of participant assignment to the intervention arm based on REDCap. Investigators, except the PI, and outcome assessors will remain blinded to arm assignment. The PI will not be able to be blinded because they will be required to do supervision and close oversight of the CHWs.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T1D-CATCH
Arm Type
Experimental
Arm Description
The CHW intervention will consist of both individual and optional group sessions with YA-URMs with T1D. In individual sessions, CHWs will provide T1D technology education, peer support, and social needs management. Over the 9-month study period, session frequency will involve weekly individual sessions based on participant technology milestones and an optional monthly CHW-led peer group support session. CHW individual and group sessions will be held via videoconferencing or in person, per participant preference and institutional COVID-19 rules.
Arm Title
Usual Care Control Condition
Arm Type
No Intervention
Arm Description
Control arm participants will receive usual primary or endocrine care at Montefiore. Usual care consists of a physician or nurse practitioner visit with review of blood sugars and treatment decisions based on provider experience. Physicians in endocrinology practices are nested within a diabetes center with access to diabetes nurse practitioners/educators, dieticians, a psychologist, and nurses. In all practices, patients are recommended to see their physician or nurse practitioner every 3 months and attend individual or group sessions.
Intervention Type
Behavioral
Intervention Name(s)
T1D-CATCH
Intervention Description
As defined by the CDC, a CHW is "a frontline public health worker who is a trusted member of a community or who has a thorough understanding of the community being served, and leverages this unique position to link health systems, social services, and communities". CHWs engender trust with patients by having direct community and lived experience, offering specific support and empathy that may be difficult for other diabetes care professionals to provide. In addition, CHWs have firsthand understanding of cultural barriers to traditional western healthcare and can promote patient-centered culturally-relevant care. They enhance team-based care by helping providers with extra outreach, social needs management, time-consuming tasks, and aligning patient-provider priorities. CHWs in this project will provide social needs assessment and management, introduction to diabetes technologies, and support for onboarding to technology.
Primary Outcome Measure Information:
Title
Technology Use
Description
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
Time Frame
9 month mark
Secondary Outcome Measure Information:
Title
YA-URM Autonomy/ Competence, Social Support
Description
Measured using the Healthcare Self-Determination survey
Time Frame
Baseline
Title
YA-URM Autonomy/ Competence, Social Support
Description
Measured using the Healthcare Self-Determination survey
Time Frame
3 month mark
Title
YA-URM Autonomy/ Competence, Social Support
Description
Measured using the Healthcare Self-Determination survey
Time Frame
6 month mark
Title
YA-URM Autonomy/ Competence, Social Support
Description
Measured using the Healthcare Self-Determination survey
Time Frame
9 month mark
Title
Hemoglobin A1c
Description
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Time Frame
Baseline
Title
Hemoglobin A1c
Description
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Time Frame
3 month mark
Title
Hemoglobin A1c
Description
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Time Frame
6 month mark
Title
Hemoglobin A1c
Description
Obtained by POC (in clinic) or laboratory (DCA Vantage)
Time Frame
9 month mark
Title
Quality of Life (Diabetes Distress)
Description
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
Time Frame
Baseline
Title
Quality of Life (Diabetes Distress)
Description
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
Time Frame
Baseline
Title
Quality of Life (Diabetes Distress)
Description
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
Time Frame
Baseline
Title
Quality of Life (Diabetes Distress)
Description
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
Time Frame
Baseline
Title
Quality of Life (Diabetes Distress)
Description
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
Time Frame
3 month follow-up
Title
Quality of Life (Diabetes Distress)
Description
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
Time Frame
3 month follow-up
Title
Quality of Life (Diabetes Distress)
Description
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
Time Frame
3 month follow-up
Title
Quality of Life (Diabetes Distress)
Description
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
Time Frame
3 month follow-up
Title
Quality of Life (Diabetes Distress
Description
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
Time Frame
6 month follow-up
Title
Quality of Life (Diabetes Distress)
Description
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
Time Frame
6 month follow-up
Title
Quality of life (Diabetes Distress)
Description
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
Time Frame
6 month follow-up
Title
Quality of Life (Diabetes Distress)
Description
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
Time Frame
6 month follow-up
Title
Technology Use
Description
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
Time Frame
3 month mark
Title
Technology Use
Description
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
Time Frame
6 month mark
Title
Technology Use
Description
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
Time Frame
9 month mark
Other Pre-specified Outcome Measures:
Title
Feasibility Check
Description
Post-intervention interviews examining intervention content, complexity, comfort, delivery, and credibility
Time Frame
6 months (post-intervention)
Title
Adoption
Description
Measured by recruitment logs
Time Frame
9 months (post-intervention)
Title
Adoption
Description
Measured by electronic medical records (EMR)
Time Frame
9 months (post-intervention)
Title
Adoption
Description
Measured by young adult participant consent rates
Time Frame
9 months (post-intervention)
Title
Adoption
Description
Measured by percentage of provider opt-in
Time Frame
9 months (post-intervention)
Title
Adoption
Description
Measured by CHW communications
Time Frame
9 months (post-intervention)
Title
Fidelity
Description
Measured by the community health worker (CHW) dashboard
Time Frame
Baseline
Title
Fidelity
Description
Measured by electronic medical records (EMR) to analyze session attendance
Time Frame
Baseline
Title
Fidelity
Description
Measured by content delivery
Time Frame
Baseline
Title
Fidelity
Description
Measured by community health workers (CHW) dashboard
Time Frame
3 month mark
Title
Fidelity
Description
Measured by CHW session recordings
Time Frame
3 month mark
Title
Fidelity
Description
Measured by EMR to analyze session attendance
Time Frame
3 month mark
Title
Fidelity
Description
Measured by content delivery
Time Frame
3 month mark
Title
Fidelity
Description
Measured by insurance tasks
Time Frame
3 month mark
Title
Fidelity
Description
Measured by CHW dashboard
Time Frame
6 month mark
Title
Fidelity
Description
Measured by CHW session recordings
Time Frame
6 month mark
Title
Fidelity
Description
Measured by EMR to analyze session attendance
Time Frame
6 month mark
Title
Fidelity
Description
Measured by content delivery
Time Frame
6 month mark
Title
Fidelity
Description
Measured by insurance tasks
Time Frame
6 month mark
Title
Cost
Description
Measured by time sheets, receipts, and budget to analyze CHW salary/benefits
Time Frame
6 months (post-intervention)
Title
Cost
Description
Measured by time sheets, receipts, and budget to analyze CHW equipment
Time Frame
6 months (post-intervention)
Title
Cost
Description
Measured by time sheets, receipts, and budget to analyze CHW consumables
Time Frame
6 months (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: T1D duration ≥6 months 18-30 years old Self-identified URM status: non-Hispanic Black or Hispanic English- or Spanish-speaking Not currently on a connected diabetes technology system (includes never offered, prescribed but not started within 3 months of receiving the device, discontinued, or previously refused technology) Exclusion Criteria: Developmental or sensory disability interfering with study participation Current pregnancy Participation in another behavioral or diabetes technology intervention study in the past 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shivani Agarwal, MD, MPH
Phone
844-556-6683
Ext
32
Email
shivani.agarwal@einsteinmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Finnan, BA
Phone
844-556-6683
Email
molly.finnan@einsteinmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivani Agarwal, MD, MPH
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivani Agarwal, MD, MPH
Phone
844-556-6683
Ext
32
Email
shivani.agarwal@einsteinmed.org
First Name & Middle Initial & Last Name & Degree
Molly Finnan, BA
Phone
844-556-6683
Ext
32
Email
molly.finnan@einsteinmed.org
First Name & Middle Initial & Last Name & Degree
Shivani Agarwal, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
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T1DTechCHW: Enhancing the Community Health Worker Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups

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