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Texts for Diabetes Control Among Homeless Persons

Primary Purpose

Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Attention Control
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring Diabetes, Homelessness, SMS text, mobile Health, Clinical trial, Health disparities

Eligibility Criteria

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

Inclusion Criteria: Homeless person age ≥ 21 Diagnosed with type 2 DM Most recent visit HbA1c ≥ 8% English/Spanish speaking Connected to study sites' shelter-clinics for care Exclusion Criteria: Pregnant or within 3 months postpartum Has an uncontrolled severe illness Has had a heart attack or stroke in the previous 6 months Inability to read/respond to texts Inability to provide informed consent Receiving inpatient care for severe substance abuse

Sites / Locations

  • George Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

The intervention (INT) will include 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education, and support.

The control (CL) will receive 6 months of texts for general health promotion.

Outcomes

Primary Outcome Measures

Change in HbA1c
Hemoglobin A1c level

Secondary Outcome Measures

Summary of Diabetes Self-Care Activities (SDSCA)
Summary of Diabetes Self-Care Activities
Proportion of Days Covered (PDC)
Medication Adherence through Proportion of Days Covered of Medications
Appointment Adherence
Proportion of appointment adherence

Full Information

First Posted
November 4, 2022
Last Updated
February 14, 2023
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT05616026
Brief Title
Texts for Diabetes Control Among Homeless Persons
Official Title
Short-messaging Services (SMS) Text for Uncontrolled Diabetes Among Persons Experiencing Homelessness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University

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
This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.
Detailed Description
Diabetes mellitus (DM) is common among persons experiencing homelessness (PEH), often inadequately managed, and carries significant costs. SMS strategies for DM have not been tested among PEH despite the accessibility of mobile phones. This study uses a SMS strategy to offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. This mixed-methods (RCT and qualitative) study will be implemented in shelter-clinics in New York City in collaboration with community organizations, allowing for sustainability and scalability. Aim 1 will evaluate the efficacy of a 6-month SMS program for DM management versus an attention control on changes in HbA1c and adherence to DM self-care activities, medications, and appointments at 9 months in adult PEH with uncontrolled DM (n=100). Outcomes will be measured at 0, 3, 6, &9 months. Aim 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with PEH and providers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes, Homelessness, SMS text, mobile Health, Clinical trial, Health disparities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention versus Control group; Randomized at the Individual level
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention (INT) will include 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education, and support.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control (CL) will receive 6 months of texts for general health promotion.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Other Intervention Name(s)
Diabetes SMS text
Intervention Description
6 months of diabetes management support via SMS texts including reminders for medication adherence, appointments, and diabetes self-care activities as well as education, and support
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
6 months of texts for general health promotion
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Hemoglobin A1c level
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Summary of Diabetes Self-Care Activities (SDSCA)
Description
Summary of Diabetes Self-Care Activities
Time Frame
9 months
Title
Proportion of Days Covered (PDC)
Description
Medication Adherence through Proportion of Days Covered of Medications
Time Frame
9 months
Title
Appointment Adherence
Description
Proportion of appointment adherence
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Homeless person age ≥ 21 Diagnosed with type 2 DM Most recent visit HbA1c ≥ 8% English/Spanish speaking Connected to study sites' shelter-clinics for care Exclusion Criteria: Pregnant or within 3 months postpartum Has an uncontrolled severe illness Has had a heart attack or stroke in the previous 6 months Inability to read/respond to texts Inability to provide informed consent Receiving inpatient care for severe substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramin Asgary, MD, MPH
Phone
917-684-9331
Email
raminasgary1@gwu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leah Bauder, MPH
Phone
970-682-0940
Email
leahbaud@gwu.edu
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramin Asgary, MD
Phone
202-994-6803
Email
raminasgary1@gwu.edu
First Name & Middle Initial & Last Name & Degree
Leah Bauder, MPH
Email
leahbaud@gwu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Texts for Diabetes Control Among Homeless Persons

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