Texts for Diabetes Control Among Homeless Persons

Sponsor

George Washington University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05616026

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: Intervention Behavioral: Attention Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Intervention versus Control group; Randomized at the Individual levelIntervention versus Control group; Randomized at the Individual level

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Short-messaging Services (SMS) Text for Uncontrolled Diabetes Among Persons Experiencing Homelessness

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Behavioral: Intervention 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 Other Names: Diabetes SMS text
Placebo Comparator: Control The control (CL) will receive 6 months of texts for general health promotion.	Behavioral: Attention Control 6 months of texts for general health promotion

Arm

Intervention/Treatment

Experimental: Intervention

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.

Behavioral: Intervention

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

Other Names:

Diabetes SMS text

Placebo Comparator: Control

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

Behavioral: Attention Control

6 months of texts for general health promotion

Outcome Measures

Primary Outcome Measures

Change in HbA1c [9 months]
Hemoglobin A1c level

Secondary Outcome Measures

Summary of Diabetes Self-Care Activities (SDSCA) [9 months]
Summary of Diabetes Self-Care Activities
Proportion of Days Covered (PDC) [9 months]
Medication Adherence through Proportion of Days Covered of Medications
Appointment Adherence [9 months]
Proportion of appointment adherence

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	George Washington University	Washington	District of Columbia	United States	20052

Sponsors and Collaborators

George Washington University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramin Asgary, Associate Professor School oh Public Health, PI, George Washington University

ClinicalTrials.gov Identifier:

NCT05616026

Other Study ID Numbers:

#11-21-ICTSHD-16

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 14, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ramin Asgary, Associate Professor School oh Public Health, PI, George Washington University

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Nov 14, 2022