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临床试验/NCT05365867
NCT05365867已完成不适用

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

Leticia R. Moczygemba6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
6
主要终点
Number of emergency department (ED) and hospital visits

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

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.

干预措施: iCAN Group (Behavioral)

结局指标

主要结局

Number of emergency department (ED) and hospital visits

时间窗: 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.

次要结局

  • Social Needs Attainment(Social need attainment will be assessed at baseline, 1, 3, 5, and 6 months post-enrollment.)
  • Social Support(Social support will be measured at baseline and 3 months and 6 months post-enrollment.)
  • Medication Adherence(Medication adherence will be measured at baseline and 3 months and 6 months post-enrollment.)
  • Psychological Distress(Psychological Distress will be measured at baseline and 3 months and 6 months post-enrollment.)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leticia R. Moczygemba

Professor

University of Texas at Austin

研究点 (6)

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