Clinical trial NCT05365867: Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals
Official title: mHealth Technology to Connect and Empower People Experiencing Homelessness to Improve Health and Social Need Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness
Medication Adherence
Social Support
Pyschological Distress
Attainment of Social Needs (i.e., Housing, Employment, Receipt of Benefits)
Keywords: mHealth among people experiencing homelessness
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: Sunrise Navigation Center
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-05-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to the iCAN group or usual care control group in parallel for the duration of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: People experiencing homelessness (PEH) are at exceptionally high risk of frequent emergency department (ED) and hospital use, poor functional outcomes, and increased morbidity and mortality from poorly managed chronic health conditions and complex social needs. Evidence-based interventions of particular promise for reducing ED and hospital utilization and improving health outcomes and meeting social needs involve:1) providing care in the community to overcome barriers including transportation and fear of stigmatization; 2) coordination of care transitions following ED or hospital discharge to improve access to needed community supports and reduce the risk of readmission; and 3) using mHealth technology to link PEH with appropriate community-based health and social services. This project builds on evidence from two feasibility studies in order to integrate and test a mHealth intervention, comprised of GPS technology and text messaging components, into a community setting to connect PEH with a community-based case manager and healthcare and social services. Our hypothesis is that integrating the mHealth intervention into an established, trusted navigation center for PEH will mitigate barriers to care and gaps in the care continuum resulting in decreased ED and hospital use and improved health outcomes and attainment of social needs. The study aim is to conduct a stratified RCT to compare a mHealth intervention with usual care community-based case management to examine the impact on healthcare utilization (primary outcome), medication adherence, social support, psychological distress and social needs attainment (secondary outcomes) in PEH.


Eligibility criteria: Inclusion Criteria:

* 18 years old Homeless (defined as where the person slept most nights in past 30 days (street, shelters, transitional housing, doubling-up with family or friends) Currently own a cell phone with service or use phone with wifi (when available) at baseline Currently prescribed ≥ 2 medications for chronic medical conditions (self-report) Diagnosis of at least two chronic health conditions (self-report): e.g., hypertension, diabetes, depression
* 2 hospitalizations or ED visits in the last 6 months (self-report) Score of at least 4 on the REALM-SF health literacy measure Score \> 17 on the Mini-Mental State Exam

Exclusion Criteria:

Unable to communicate verbally in English. This is an exclusion criteria because the text messaging, apps, procedures and measures are not validated in in other languages.

Primary outcomes:
measure: Number of emergency department (ED) and hospital visits
timeFrame: Number of ED and hospital visits from baseline to 6 months post-enrollment (primary outcome), and from 6 months post-enrollment to 12 months post-enrollment (sustained impact of the intervention).
Secondary outcomes:
measure: Medication Adherence
timeFrame: Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.
measure: Social Support
timeFrame: Social support will be measured at baseline and 3 months and 6 months post-enrollment.
measure: Psychological Distress
timeFrame: Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.
measure: Social Needs Attainment
timeFrame: Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.
Other outcomes:
measure: Process measures in iCAN group
timeFrame: Process measures will be collected at 1, 3, 5, and 6 months post-enrollment visits in the iCAN group.
measure: Technology and Case Manager Assessment
timeFrame: The technology and case manager assessment will occur at the 6-month post-enrollment visit.
Locations:
city: Austin
country: United States
facility: Trinity Center
state: Texas
city: Austin
country: United States
facility: Sunrise Navigation Center
state: Texas
city: Austin
country: United States
facility: Charlie Center
state: Texas
Study officials:
References: