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

Medication Adherence Clinical Trial

— iCAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365867
• Other study ID #: STUDY000026665
• Secondary ID: R18HS027750
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: University of Texas at Austin
• Contact: Leticia R Moczygemba, PharmD, PhD
• Phone: 5127737924
• Email: lrmoczygemba[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Medication Adherence
• Social Support

Intervention

Behavioral:
• iCAN Group
See description in iCAN study arm.

Locations

Country	Name	City	State
United States	Charlie Center	Austin	Texas
United States	Sunrise Navigation Center	Austin	Texas
United States	Trinity Center	Austin	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Texas at Austin	Agency for Healthcare Research and Quality (AHRQ), Sunrise Navigation Center, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process measures in 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.	Process measures will be collected at 1, 3, 5, and 6 months post-enrollment visits in the iCAN group.
Other	Technology and Case Manager Assessment	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.	The technology and case manager assessment will occur at the 6-month post-enrollment visit.
Primary	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.	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	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.	Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.
Secondary	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.	Social support will be measured at baseline and 3 months and 6 months post-enrollment.
Secondary	Psychological Distress	The Kessler Psychological Distress Scale - 6 (K6) is comprised of 6 items that assess feelings of anxiety and depression.	Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.
Secondary	Social Needs Attainment	Three questions will be used to assess changes in housing and employment status and receipt of benefits.	Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.