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Completed

NCT Number: NCT05365867

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charlie Center, Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iCAN Group

Behavioral

See description in iCAN study arm.

Primary outcomes

  1. Number of emergency department (ED) and hospital visits

    Time frame: 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).

    Number of ED and hospital visits data will come from medical records from the local health information exchange.

Secondary outcomes

  1. Medication Adherence

    Time frame: Medication 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.

  2. Social Support

    Time frame: Social 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.

  3. Psychological Distress

    Time frame: Psychological 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.

  4. Social Needs Attainment

    Time frame: Social 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.

Other outcomes

  1. Process measures in iCAN group

    Time frame: Process measures will be collected at 1, 3, 5, and 6 months post-enrollment visits in the iCAN group.

    A number of process measures will be collected in the iCAN group. Process measures will include percentage of valid responses to text message surveys, number of case manager telephone consultations, description of type and number of case manager interventions, number of times case manager uses GPS to locate a participant, and technology issues/concerns.

  2. Technology and Case Manager Assessment

    Time frame: The technology and case manager assessment will occur at the 6-month post-enrollment visit.

    At the end of the study, participants in the iCAN group will complete a modification of the Technology Acceptance Questionnaire to evaluate the acceptance of the mobile health technology and integration of case manager.

Sponsors and collaborators

Lead sponsor

Leticia R. Moczygemba

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Sunrise Navigation Center
  • University of Maryland

Registry information

Official study title

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

Acronym: iCAN

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 9, 2022
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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