Number of Emergency Department and Hospital Visits Among Adults Experiencing HomelessnessiCANNCT05365867
Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals
A study testing iCAN Group in people with Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness and Medication Adherence, run by Leticia R. Moczygemba at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness, Medication Adherence, Social Support
- What is being tested?
- iCAN Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 May 2022to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Trinity Center
Austin, Texas, 78701
Sunrise Navigation Center
Austin, Texas, 78745
Charlie Center
Austin, Texas, 78759
About this study
Official title: mHealth Technology to Connect and Empower People Experiencing Homelessness to Improve Health and Social Need Outcomes
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.
- 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)
- Being tested
- iCAN Group
- Keywords
- mHealth among people experiencing homelessness
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCAN GroupBehavioural
See description in iCAN study arm.
| Study group | Role | What they receive |
|---|---|---|
| iCAN Group | Experimental | iCAN is comprised of text messaging, GPS technology, preloaded apps, and telephone case management integrated within a community-based navigation center. Participants will receive 3 - 5 messages daily regarding medication adherence and appointment reminders, general health messages, motivational messages, and as needed messages for local information (e.g., weather updates). Within 48 - 72 hours of enrollment, participants will be called on their study phone by the study case manager for an intake assessment that will take 30 - 45 minutes in duration. The purpose of the assessment is to identify relevant health and social needs that the case manager can assist the participant in addressing by connecting with other medical and social services in the community. Within 48 - 72 hours of notification of a ED or hospital visit the iCAN case manager will call the participant on the study phone to assess care coordination needs for managing discharge instructions. Receives: Behavioral: iCAN Group |
| Usual Care Control (UCC) | No intervention | Participants randomized to the UCC group will have access to their personal phones and use it in the usual manner with no installment of apps, text messages, or case manager interventions. Since the majority of PEH have a cell phone of some type, this will allow us to compare the intervention to how PEH typically use their cell phones. Also, the UCC will have access to all of the services available at any of the enrollment sites but no formal interaction from the iCAN case manager and no option of text messaging with the iCAN case manager. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of emergency department (ED) and hospital visits
Number of ED and hospital visits data will come from medical records from the local health information exchange.
Measured: 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 (4)
Medication Adherence
Medication adherence will be measured using the Hill-Bone Medication Adherence Scale, a 9-item scale that measures medication adherence for chronic conditions.
Measured: Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.
Social Support
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.
Measured: Social support will be measured at baseline and 3 months and 6 months post-enrollment.
Psychological Distress
The Kessler Psychological Distress Scale - 6 (K6) is comprised of 6 items that assess feelings of anxiety and depression.
Measured: Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.
Social Needs Attainment
Three questions will be used to assess changes in housing and employment status and receipt of benefits.
Measured: Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start17 May 2022
- Primary completion18 Dec 2023
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Number of Emergency Department and Hospital Visits Among Adults Experiencing HomelessnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to the iCAN group or usual care control group in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leticia R. Moczygemba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Sunrise Navigation Center, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor-investigator, Leticia R. Moczygemba, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365867
- Sponsor's protocol ID
- STUDY000026665
- Other IDs
- R18HS027750
- Acronym
- iCAN
- Status last verified
- Aug 2024
- First submitted
- 3 May 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Technology to Connect and Empower People Experiencing Homelessness to Improve Health and Social Need Outcomes
- ClinicalTrials.gov ID
- NCT05365867
- Acronym / sponsor ID
- iCAN / STUDY000026665
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Leticia R. MoczygembaUniversity, hospital or other
- Collaborators
- University of Maryland, Sunrise Navigation Center, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to the iCAN group or usual care control group in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| iCAN Group | Experimental | Behavioral: iCAN GroupiCAN is comprised of text messaging, GPS technology, preloaded apps, and telephone case management integrated within a community-based navigation center. Participants will receive 3 - 5 messages daily regarding medication adherence and appointment reminders, general health messages, motivational messages, and as needed messages for local information (e.g., weather updates). Within 48 - 72 hours of enrollment, participants will be called on their study phone by the study case manager for an intake assessment that will take 30 - 45 minutes in duration. The purpose of the assessment is to identify relevant health and social needs that the case manager can assist the participant in addressing by connecting with other medical and social services in the community. Within 48 - 72 hours of notification of a ED or hospital visit the iCAN case manager will call the participant on the study phone to assess care coordination needs for managing discharge instructions. |
| Usual Care Control (UCC) | No intervention | –Participants randomized to the UCC group will have access to their personal phones and use it in the usual manner with no installment of apps, text messages, or case manager interventions. Since the majority of PEH have a cell phone of some type, this will allow us to compare the intervention to how PEH typically use their cell phones. Also, the UCC will have access to all of the services available at any of the enrollment sites but no formal interaction from the iCAN case manager and no option of text messaging with the iCAN case manager. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCAN GroupSee description in iCAN study arm. | Behavioural | iCAN Group |
Primary outcome
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.
4 secondary outcomes
Medication Adherence
Time frame: Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.
Social Support
Time frame: Social support will be measured at baseline and 3 months and 6 months post-enrollment.
Psychological Distress
Time frame: Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.
Social Needs Attainment
Time frame: Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCAN Group in people with Number of Emergency Department and Hospital Visits Among Adults Experiencing Homelessness and Medication Adherence, run by Leticia R. Moczygemba at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.