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Trial record 4 of 29 for:    texting | Boston, Massachusetts, U.S.

Self-Management Using Text Messaging in a Homeless Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034993
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Boston Health Care for the Homeless Program
Information provided by (Responsible Party):
Donald Keith McInnes, Boston University

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE July 21, 2017
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Emergency Department Visits Made [ Time Frame: 4 months ]
Data from BHCHP's electronic medical record (EMR) and from the Coordinated Care Hub electronic case management system in use by the Care Hub organizations, which includes admission and discharge data
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03034993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Inpatient admissions [ Time Frame: 4 months ]
    Similar to Emergency Department visit data, this will come from BHCHP's EMR and from the electronic case management system
  • Appointment keeping [ Time Frame: 4 months ]
    Ratio of kept appointments to all appointments scheduled, based on the BHCHP EMR (e.g. 0-100%).
  • Medication Adherence [ Time Frame: 4 months ]
    Self report medication adherence is assessed with 2 measures: Morisky adherence scale, (range, 0=poor to 11=excellent) and a 1-item rating question in which patients rate their ability to take all their medications as prescribed (range, 1=very poor to 6=excellent)
  • Adult Well-Being Assessment [ Time Frame: 4 months ]
    This 9-item health-related quality of life (HRQOL) assessment is a validated measure developed by the Institute for Healthcare Improvement.
  • Comfort with Computers and Cell Phones [ Time Frame: 4 months ]
    The eHealth Literacy Scale, eHEALS, (range 8-40, higher equals greater self-efficacy) assesses comfort with computers and the Internet for health related purposes. Investigators will also adapt eHEALS so that separate items can be asked about comfort with cell phone use.
  • Frequency of Cell Phone Use and Computer Use [ Time Frame: 4 months ]
    Measures come from the Health Information National Trends Survey (HINTS). Scale ranges from 0 (no use) to 12 (frequent use of many features).
  • Outpatient appointments [ Time Frame: 4 months ]
    Number of outpatient visits made
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Inpatient admissions [ Time Frame: 4 months ]
    Similar to Emergency Department visit data, this will come from BHCHP's EMR and from the electronic case management system
  • Appointment keeping [ Time Frame: 4 months ]
    Ratio of kept appointments to all appointments scheduled, based on the BHCHP EMR (e.g. 0-100%).
  • Medication Adherence [ Time Frame: 4 months ]
    Self report medication adherence is assessed with 2 measures: Morisky adherence scale, (range, 0=poor to 11=excellent) and a 1-item rating question in which patients rate their ability to take all their medications as prescribed (range, 1=very poor to 6=excellent)
  • Adult Well-Being Assessment [ Time Frame: 4 months ]
    This 9-item health-related quality of life (HRQOL) assessment is a validated measure developed by the Institute for Healthcare Improvement.
  • Patient Activation Measure [ Time Frame: 4 months ]
    A validated measure of patient agency, self-efficacy, and knowledge about how to manage one's health20. PAM is on a scale rating of 1-4.
  • Comfort with Computers and Cell Phones [ Time Frame: 4 months ]
    The eHealth Literacy Scale, eHEALS, (range 8-40, higher equals greater self-efficacy) assesses comfort with computers and the Internet for health related purposes. We will also adapt eHEALS so that separate items can be asked about comfort with cell phone use.
  • Frequency of Cell Phone Use and Computer Use [ Time Frame: 4 months ]
    We use measures from the Health Information National Trends Survey (HINTS). Scale ranges from 0 (no use) to 12 (frequent use of many features).
  • Outpatient appointments [ Time Frame: 4 months ]
    Number of outpatient visits made
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-Management Using Text Messaging in a Homeless Population
Official Title  ICMJE Improving Self-Management of Chronic Conditions Among Homeless Persons: a Community-Based Participatory Approach Using Text Messaging
Brief Summary The purpose of this study is to determine if an automated text message intervention is beneficial for homeless patients in reducing their hospital visits, increasing their primary care appointments, and help them increase medication adherence.
Detailed Description

Boston Healthcare for the Homeless Program (BHCHP) is the study site for this research. It is the largest freestanding health care for the homeless program in the country - it provides primary care, behavioral health, oral health care and other wrap-around services to 12,500 homeless individuals a year. BHCHP was recently awarded a two-year grant from the Massachusetts Health Policy Commission to demonstrate how intensive, coordinated case management can reduce costs of caring for homeless persons who are high utilizers of emergency department (ED) and inpatient care. The Social Determinants of Health Coordinated Care Hub for Homeless Adults project (hereafter the "Care Hub") will create capacity among 9 Boston organizations serving homeless residents to meet their needs in primary care, behavioral health, housing, and shelter. This will improve quality of life, health outcomes, and care efficiency for the organizations. The participating organizations, in addition to BHCHP, are Bay Cove Human Services, Boston Public Health Commission, Boston Rescue Mission, Casa Esperanza, Massachusetts Housing and Shelter Alliance, The New England Center and Home for Veterans, St. Francis House, Victory Programs Specifically the investigators anticipate that patients participating in the Care Hub will have reduced use of ED and inpatient care because they will be better linked to and retained in appropriate care such as outpatient, mental health, substance use disorder (SUD), preventive care, and respite care. Regular care will increase the appropriate management of chronic health conditions and reduce episodes of exacerbations of these conditions which often lead to ED and hospital care. The purpose of this study is to evaluate whether an a text messaging system of appointment reminders, along with medication taking messages, and text messages about mood will augment the effectiveness of the Care Hub program.

The investigators propose to pilot a cell phone-based outpatient care support and medication reminder system. The content will include appointment reminders and educational and motivational messages about the importance of going to all outpatient care visits and of taking medications. The investigators take a community-based participatory research approach to this study - both because it appropriately considers the needs of the target population (increasing the likelihood of success) and because it empowers a population that is often treated as if its members were powerless. The cell phone texting intervention will help patients stay engaged in care, adhere to their medications, and adopt and sustain behavior change. This will be accomplished by completing a series of objectives:

  1. To develop a text messaging system designed for homeless patients which includes appointment reminders, medication taking reminders and motivation, and texts messages that allow participants to report their mood, all in support of chronic disease management. The system will be based on a health coaching model, and message content will be reviewed and edited by patients who are members of drafted by patient members of a BHCHP Community Innovation Panel (CIP).
  2. To train Care Hub intervention patients (or refresh existing skills) in cell phone text messaging.
  3. To test the text messaging system in a randomized pilot study with 60 patients, comparing outpatient, respite care, ED, and inpatient utilization, and Health-Related Quality of Care (HRQOL) between the 30 intervention and 30 control patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Disease
Intervention  ICMJE Behavioral: Text Messaging
Subjects will receive text messages with reminders of their upcoming outpatient health care appointments at the Boston Health Care for the Homeless Program (BHCHP) clinic. The text message will indicate the time of the appointment and the location (e.g. "Remember appointment Friday March 15 at 10am in the Yawkey building"). Appointment reminder text messages will be sent 3 days ahead and again 1 day ahead of the appointment date. Medication related texts will be sent every other day and will be educational and motivational (e.g. "Keep taking medications that way the doctor prescribed them, even if feeling fine"). Mood related texts will also be sent every other day and ask about mood on a 1 to 5 scale. The participant will text back a response.
Study Arms  ICMJE
  • Experimental: Text Messaging
    This group will receive text messages with appointment reminders, medication taking education and motivation, and for reporting of mood.
    Intervention: Behavioral: Text Messaging
  • Placebo Comparator: Control
    This group will receive simple text messages about general health promotion, such as about the importance of drinking water on hot days, using sunscreen, etc.
    Intervention: Behavioral: Text Messaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 2, 2018)
64
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
60
Estimated Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • is a patient participant in the Coordinated Care Hub Initiative
  • is willing to receive text messages
  • is able to understand English - spoken and read

Exclusion Criteria:

  • has an inability to find, open, and respond to a test text message
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034993
Other Study ID Numbers  ICMJE H-35967
catalyst grant ( Other Identifier: BU SPH )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Donald Keith McInnes, Boston University
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE Boston Health Care for the Homeless Program
Investigators  ICMJE
Principal Investigator: Donald K McInnes, ScD Boston University and Department of Veterans Affairs
PRS Account Boston University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP