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Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking Among Homeless Adults (Smart-T)

Primary Purpose

Alcohol Use Disorder, Treatment, Homelessness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMA + App/Treatment Messages
Sponsored by
University of North Texas Health Science Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Score ≥ 8 on the AUDIT
  • Report consuming ≥ 1 drink of alcohol in the past week
  • Receiving treatment at Metrocare;
  • Willing and able to complete the baseline and follow-up visits;
  • Score ≥ 4 on the REALM-SF, indicating > 6th grade English literacy level
  • Score ≥ 24 on the Mini-Mental State Exam

Exclusion Criteria:

  • Circulation problems, neuropathy, deep vein thrombosis, leg ulcers, tendonitis, diabetes, pregnancy, history of swelling or nickel or other metal allergies that would prohibit wearing the SCRAM ankle bracelet.
  • Self-reported discomfort wearing an alcohol sensing bracelet for 4 weeks.
  • Previously participated in Phase I (for Phase III recruitment).

Sites / Locations

  • Bridge Homeless Recovery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

EMA only

EMA + App/Treatment Messages

Arm Description

Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment.

Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are receiving shelter-based treatment. The investigators will compare Phase III participants (i.e., received Metrocare, EMAs, and tailored treatment messages) to Phase I participants (i.e., received Metrocare and EMAs only) to examine the preliminary effectiveness of the app.

Outcomes

Primary Outcome Measures

Satisfaction With App Treatment Messages
Satisfaction with app on self-reported questions at follow-up (1-5 scale where 1 = Not at all; and 5 = Extremely)

Secondary Outcome Measures

Number of Drinking Days
Number of drinking days (number of days with any self-reported drinking out of 28 days)
Number of Heavy Drinking Days
Number of drinking days (number of days with self-reported >4 drinks for men; >3 drinks for women out of 28 days)

Full Information

First Posted
November 13, 2018
Last Updated
November 8, 2022
Sponsor
University of North Texas Health Science Center
Collaborators
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT03746808
Brief Title
Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking Among Homeless Adults
Acronym
Smart-T
Official Title
Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Homeless adults are 8 times as likely to be alcohol dependent compared with adults in the general population, yet few studies have examined the precipitants of alcohol use in this vulnerable population. Ecological momentary assessments (EMAs) that involve repeated assessment of thoughts/mood/behaviors (e.g., via smart phone) is currently the most accurate way to assess individuals in real-time in their natural environments. Advances in smartphone technology also allow for the collection of continuous geolocation and other passive sensing data. Thus, researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone. Building on prior work, this study will use a three-phase study to develop and test a "just in time" adaptive intervention to reduce alcohol use in homeless men and women. Phase I will use smartphones and passive sensing technologies to monitor geolocation, psychosocial variables (e.g., stress, affect, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. Phase I will identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use over 4 weeks. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent drinking. The resulting app will assess imminent risk of alcohol use after each EMA and will deliver relevant treatment messages that match a person's current risk factors. Phase III will test the feasibility, acceptability and preliminary efficacy of the app in a sample of 40 homeless adults with an AUD who receive the EMA plus treatment messages over 4 weeks. Drinking will be determined via self-report, supplemented by a transdermal alcohol sensor (i.e., SCRAM) worn by participants. This project will be the first to combine geolocation and psychosocial variables to identify real-time antecedents of drinking. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with alcohol use disorders.
Detailed Description
An estimated 6.2% of US adults will be homeless at some point in their lifetime. Homeless adults have higher rates of disease, greater risk of interpersonal violence, shorter life expectancies, and disproportionately higher health care utilization and costs compared to housed individuals. A significant contributor to morbidity and mortality among homeless adults is the high prevalence of alcohol use. Approximately 33% of homeless adults have current alcohol dependence, a rate nearly 8 times that of the general population. Although shelter-based treatments are common, compliance is typically poor. Identifying factors that influence alcohol use would significantly improve the ability to develop effective interventions and engage homeless adults in treatment. Relatively little is known about the environmental, cognitive, and behavioral antecedents of alcohol use in homeless adults. Like other subgroups, alcohol use has most often been examined using traditional lab/clinic based assessment methods that are not well suited to capturing the complicated street-level interactions experienced by most homeless adults. Traditional assessment methodologies may also provide biased and/or inaccurate estimates due to recall biases and errors in memory, particularly in this complicated population. Ecological momentary assessment (EMA), in which handheld devices (e.g., smartphones) are used to capture moment-to-moment experience, is currently the most accurate way to measure phenomena in natural settings. Additionally, recent technological advances have made it possible to collect continuous geolocation data alongside EMA. Researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone. This pilot study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults enrolled in shelter-based treatment for an AUD. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use. Phase II will modify an existing app, previously validated for smoking cessation, to create the intervention. Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are enrolled in shelter-based treatment. Alcohol consumption will be validated via a transdermal alcohol sensor (i.e., SCRAM) worn by participants in Phases I and III. The central hypothesis is that alcohol use is strongly affected by moment-to-moment risk and protective factors. This study will be able to use EMAs to identify and automatically intervene during moments when people are at high risk for drinking. This hypothesis is based on preliminary findings among homeless, justice-involved, and socioeconomically disadvantaged safety-net hospital patients. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with AUDs. This project will: Use EMA to identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use among 80 homeless adults with an AUD who are receiving shelter-based treatment. Informed by Aim 1 findings, develop a "just-in-time" adaptive intervention to reduce alcohol use, including an alcohol use risk algorithm and corresponding theory-based treatment messages. Examine feasibility, acceptability, and preliminary effectiveness of a just-in-time adaptive smartphone app among 40 homeless adults with an AUD who are receiving shelter-based treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Treatment, Homelessness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMA only
Arm Type
Placebo Comparator
Arm Description
Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment.
Arm Title
EMA + App/Treatment Messages
Arm Type
Active Comparator
Arm Description
Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are receiving shelter-based treatment. The investigators will compare Phase III participants (i.e., received Metrocare, EMAs, and tailored treatment messages) to Phase I participants (i.e., received Metrocare and EMAs only) to examine the preliminary effectiveness of the app.
Intervention Type
Behavioral
Intervention Name(s)
EMA + App/Treatment Messages
Intervention Description
This study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are enrolled in shelter-based treatment. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use.
Primary Outcome Measure Information:
Title
Satisfaction With App Treatment Messages
Description
Satisfaction with app on self-reported questions at follow-up (1-5 scale where 1 = Not at all; and 5 = Extremely)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of Drinking Days
Description
Number of drinking days (number of days with any self-reported drinking out of 28 days)
Time Frame
4 weeks
Title
Number of Heavy Drinking Days
Description
Number of drinking days (number of days with self-reported >4 drinks for men; >3 drinks for women out of 28 days)
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Score ≥ 8 on the AUDIT Report consuming ≥ 1 drink of alcohol in the past week Receiving treatment at Metrocare; Willing and able to complete the baseline and follow-up visits; Score ≥ 4 on the REALM-SF, indicating > 6th grade English literacy level Score ≥ 24 on the Mini-Mental State Exam Exclusion Criteria: Circulation problems, neuropathy, deep vein thrombosis, leg ulcers, tendonitis, diabetes, pregnancy, history of swelling or nickel or other metal allergies that would prohibit wearing the SCRAM ankle bracelet. Self-reported discomfort wearing an alcohol sensing bracelet for 4 weeks. Previously participated in Phase I (for Phase III recruitment).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Walters, PhD
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridge Homeless Recovery Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35869820
Citation
Walters ST, Mun EY, Tan Z, Luningham JM, Hebert ET, Oliver JA, Businelle MS. Development and preliminary effectiveness of a smartphone-based, just-in-time adaptive intervention for adults with alcohol misuse who are experiencing homelessness. Alcohol Clin Exp Res. 2022 Sep;46(9):1732-1741. doi: 10.1111/acer.14908. Epub 2022 Aug 7.
Results Reference
result
PubMed Identifier
34134874
Citation
Walters ST, Businelle MS, Suchting R, Li X, Hebert ET, Mun EY. Using machine learning to identify predictors of imminent drinking and create tailored messages for at-risk drinkers experiencing homelessness. J Subst Abuse Treat. 2021 Aug;127:108417. doi: 10.1016/j.jsat.2021.108417. Epub 2021 Apr 20.
Results Reference
result
PubMed Identifier
33583057
Citation
Mun EY, Li X, Businelle MS, Hebert ET, Tan Z, Barnett NP, Walters ST. Ecological Momentary Assessment of Alcohol Consumption and Its Concordance with Transdermal Alcohol Detection and Timeline Follow-Back Self-report Among Adults Experiencing Homelessness. Alcohol Clin Exp Res. 2021 Apr;45(4):864-876. doi: 10.1111/acer.14571. Epub 2021 Mar 3.
Results Reference
result
PubMed Identifier
32297874
Citation
Businelle MS, Walters ST, Mun EY, Kirchner TR, Hebert ET, Li X. Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention. JMIR Res Protoc. 2020 Apr 16;9(4):e15610. doi: 10.2196/15610.
Results Reference
result

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Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking Among Homeless Adults

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