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Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals

mHealth Technology to Connect and Empower People Experiencing Homelessness to Improve Health and Social Need Outcomes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05365867
Acronym
iCAN
Enrollment
120
Registered
2022-05-09
Start date
2022-05-17
Completion date
2024-06-18
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attainment of Social Needs (i.e., Housing, Employment, Receipt of Benefits), Medication Adherence, Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness, Pyschological Distress, Social Support

Keywords

mHealth among people experiencing homelessness

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.

Interventions

BEHAVIORALiCAN Group

See description in iCAN study arm.

Sponsors

Leticia R. Moczygemba
Lead SponsorOTHER
University of Maryland
CollaboratorOTHER
Sunrise Navigation Center
CollaboratorUNKNOWN
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

The biostatistician is masked to who is in the intervention or usual care group.

Intervention model description

Participants are randomized to the iCAN group or usual care control group in parallel for the duration of the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of emergency department (ED) and hospital visitsNumber 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).Number of ED and hospital visits data will come from medical records from the local health information exchange.

Secondary

MeasureTime frameDescription
Medication AdherenceMedication adherence will be measured at baseline and 3 months and 6 months post-enrollment.Medication adherence will be measured using the Hill-Bone Medication Adherence Scale, a 9-item scale that measures medication adherence for chronic conditions.
Social SupportSocial support will be measured at baseline and 3 months and 6 months post-enrollment.Social support will be measured using the modified 8-item Medical Outcomes Study Social Support Survey, a valid and reliable tool in multiple groups across various conditions.
Psychological DistressPsychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.The Kessler Psychological Distress Scale - 6 (K6) is comprised of 6 items that assess feelings of anxiety and depression.
Social Needs AttainmentSocial need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.Three questions will be used to assess changes in housing and employment status and receipt of benefits.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026