Chronic DiseaseNCT03034993
Self-Management Using Text Messaging in a Homeless Population
A study testing Text Messaging in people with Chronic Disease, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 30 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is a patient participant in the Coordinated Care Hub Initiative
- is willing to receive text messages
- is able to understand English - spoken and read
Who cannot join
- has an inability to find, open, and respond to a test text message
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
Official title: Improving Self-Management of Chronic Conditions Among Homeless Persons: a Community-Based Participatory Approach Using Text Messaging
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.
Read the 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:
- 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).
- To train Care Hub intervention patients (or refresh existing skills) in cell phone text messaging.
- 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.
- Conditions
- Chronic Disease
- Being tested
- Text Messaging
- Keywords
- Healthcare for homeless, Text messages, Primary care visits, Medication adherence, Inpatient admissions
- Medical subject headings
- Chronic Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Text Messaging | Experimental | This group will receive text messages with appointment reminders, medication taking education and motivation, and for reporting of mood. Receives: Behavioral: Text Messaging |
| Control | Placebo comparator | 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. Receives: Behavioral: Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Visits Made
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
Measured: 4 months
Secondary outcomes (7)
Inpatient admissions
Similar to Emergency Department visit data, this will come from BHCHP's EMR and from the electronic case management system
Measured: 4 months
Appointment keeping
Ratio of kept appointments to all appointments scheduled, based on the BHCHP EMR (e.g. 0-100%).
Measured: 4 months
Medication Adherence
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)
Measured: 4 months
Adult Well-Being Assessment
This 9-item health-related quality of life (HRQOL) assessment is a validated measure developed by the Institute for Healthcare Improvement.
Measured: 4 months
Comfort with Computers and Cell Phones
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.
Measured: 4 months
Frequency of Cell Phone Use and Computer Use
Measures come from the Health Information National Trends Survey (HINTS). Scale ranges from 0 (no use) to 12 (frequent use of many features).
Measured: 4 months
Outpatient appointments
Number of outpatient visits made
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start21 Jul 2017
- Primary completion30 Dec 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Health Care for the Homeless Program
- Responsible party
- Principal investigator, Donald Keith McInnes, Boston University
- Investigators
- Donald K McInnes, ScD, Principal investigator, Boston University and Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034993
- Sponsor's protocol ID
- H-35967
- Other IDs
- catalyst grant
- Status last verified
- May 2019
- First submitted
- 26 Jan 2017
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barrow SM, Herman DB, Cordova P, Struening EL. Mortality among homeless shelter residents in New York City. Am J Public Health. 1999 Apr;89(4):529-34. doi: 10.2105/ajph.89.4.529.
PubMed 10191796Hwang SW, Aubry T, Palepu A, Farrell S, Nisenbaum R, Hubley AM, Klodawsky F, Gogosis E, Hay E, Pidlubny S, Dowbor T, Chambers C. The health and housing in transition study: a longitudinal study of the health of homeless and vulnerably housed adults in three Canadian cities. Int J Public Health. 2011 Dec;56(6):609-23. doi: 10.1007/s00038-011-0283-3. Epub 2011 Aug 20.
PubMed 21858461Krousel-Wood M, Thomas S, Muntner P, Morisky D. Medication adherence: a key factor in achieving blood pressure control and good clinical outcomes in hypertensive patients. Curr Opin Cardiol. 2004 Jul;19(4):357-62. doi: 10.1097/01.hco.0000126978.03828.9e.
PubMed 15218396Kidder DP, Wolitski RJ, Campsmith ML, Nakamura GV. Health status, health care use, medication use, and medication adherence among homeless and housed people living with HIV/AIDS. Am J Public Health. 2007 Dec;97(12):2238-45. doi: 10.2105/AJPH.2006.090209. Epub 2007 Oct 30.
PubMed 17971562Craig GM, Booth H, Story A, Hayward A, Hall J, Goodburn A, Zumla A. The impact of social factors on tuberculosis management. J Adv Nurs. 2007 Jun;58(5):418-24. doi: 10.1111/j.1365-2648.2007.04257.x. Epub 2007 Apr 17.
PubMed 17442025Kushel MB, Vittinghoff E, Haas JS. Factors associated with the health care utilization of homeless persons. JAMA. 2001 Jan 10;285(2):200-6. doi: 10.1001/jama.285.2.200.
PubMed 11176814Kushel MB, Perry S, Bangsberg D, Clark R, Moss AR. Emergency department use among the homeless and marginally housed: results from a community-based study. Am J Public Health. 2002 May;92(5):778-84. doi: 10.2105/ajph.92.5.778.
PubMed 11988447Clarke J, Proudfoot J, Ma H. Mobile Phone and Web-based Cognitive Behavior Therapy for Depressive Symptoms and Mental Health Comorbidities in People Living With Diabetes: Results of a Feasibility Study. JMIR Ment Health. 2016 May 31;3(2):e23. doi: 10.2196/mental.5131.
PubMed 27245948Nelson LA, Mulvaney SA, Gebretsadik T, Ho YX, Johnson KB, Osborn CY. Disparities in the use of a mHealth medication adherence promotion intervention for low-income adults with type 2 diabetes. J Am Med Inform Assoc. 2016 Jan;23(1):12-8. doi: 10.1093/jamia/ocv082. Epub 2015 Jul 17.
PubMed 26186935Whynes DK, MLitt BA, Giggs JA. The health of the Nottingham homeless. Public Health. 1992 Jul;106(4):307-14. doi: 10.1016/s0033-3506(05)80424-x.
PubMed 1529093Riley ED, Neilands TB, Moore K, Cohen J, Bangsberg DR, Havlir D. Social, structural and behavioral determinants of overall health status in a cohort of homeless and unstably housed HIV-infected men. PLoS One. 2012;7(4):e35207. doi: 10.1371/journal.pone.0035207. Epub 2012 Apr 25.
PubMed 22558128Emeche U. Is a strategy focused on super-utilizers equal to the task of health care system transformation? Yes. Ann Fam Med. 2015 Jan-Feb;13(1):6-7. doi: 10.1370/afm.1746. No abstract available.
PubMed 25583884Chambers C, Chiu S, Katic M, Kiss A, Redelmeier DA, Levinson W, Hwang SW. High utilizers of emergency health services in a population-based cohort of homeless adults. Am J Public Health. 2013 Dec;103 Suppl 2(Suppl 2):S302-10. doi: 10.2105/AJPH.2013.301397. Epub 2013 Oct 22.
PubMed 24148033Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Annu Rev Public Health. 1998;19:173-202. doi: 10.1146/annurev.publhealth.19.1.173.
PubMed 9611617Larimer ME, Malone DK, Garner MD, Atkins DC, Burlingham B, Lonczak HS, Tanzer K, Ginzler J, Clifasefi SL, Hobson WG, Marlatt GA. Health care and public service use and costs before and after provision of housing for chronically homeless persons with severe alcohol problems. JAMA. 2009 Apr 1;301(13):1349-57. doi: 10.1001/jama.2009.414.
PubMed 19336710
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-Management of Chronic Conditions Among Homeless Persons: a Community-Based Participatory Approach Using Text Messaging
- ClinicalTrials.gov ID
- NCT03034993
- Acronym / sponsor ID
- H-35967
- Conditions
- Chronic Disease
- Keywords
- Healthcare for homeless, Text messages, Primary care visits, Medication adherence, Inpatient admissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Boston Health Care for the Homeless Program
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
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:
- 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).
- To train Care Hub intervention patients (or refresh existing skills) in cell phone text messaging.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messaging | Experimental | Behavioral: Text MessagingThis group will receive text messages with appointment reminders, medication taking education and motivation, and for reporting of mood. |
| Control | Placebo comparator | Behavioral: Text MessagingThis group will receive simple text messages about general health promotion, such as about the importance of drinking water on hot days, using sunscreen, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- is a patient participant in the Coordinated Care Hub Initiative
- is willing to receive text messages
- is able to understand English - spoken and read
Key exclusion criteria (1 listed)
- has an inability to find, open, and respond to a test text message
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 |
|---|---|---|
| Text MessagingSubjects 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. | Behavioural | Control, Text Messaging |
Primary outcome
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
7 secondary outcomes
Inpatient admissions
Time frame: 4 months
Appointment keeping
Time frame: 4 months
Medication Adherence
Time frame: 4 months
Adult Well-Being Assessment
Time frame: 4 months
Comfort with Computers and Cell Phones
Time frame: 4 months
Frequency of Cell Phone Use and Computer Use
Time frame: 4 months
Outpatient appointments
Time frame: 4 months
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 3 May 2019.
- Background: PubMed 10191796Barrow SM, Herman DB, Cordova P, Struening EL. Mortality among homeless shelter residents in New York City. Am J Public Health. 1999 Apr;89(4):529-34. doi: 10.2105/ajph.89.4.529.
- Background: PubMed 21858461Hwang SW, Aubry T, Palepu A, Farrell S, Nisenbaum R, Hubley AM, Klodawsky F, Gogosis E, Hay E, Pidlubny S, Dowbor T, Chambers C. The health and housing in transition study: a longitudinal study of the health of homeless and vulnerably housed adults in three Canadian cities. Int J Public Health. 2011 Dec;56(6):609-23. doi: 10.1007/s00038-011-0283-3. Epub 2011 Aug 20.
- Background: PubMed 15218396Krousel-Wood M, Thomas S, Muntner P, Morisky D. Medication adherence: a key factor in achieving blood pressure control and good clinical outcomes in hypertensive patients. Curr Opin Cardiol. 2004 Jul;19(4):357-62. doi: 10.1097/01.hco.0000126978.03828.9e.
- Background: PubMed 17971562Kidder DP, Wolitski RJ, Campsmith ML, Nakamura GV. Health status, health care use, medication use, and medication adherence among homeless and housed people living with HIV/AIDS. Am J Public Health. 2007 Dec;97(12):2238-45. doi: 10.2105/AJPH.2006.090209. Epub 2007 Oct 30.
- Background: PubMed 17442025Craig GM, Booth H, Story A, Hayward A, Hall J, Goodburn A, Zumla A. The impact of social factors on tuberculosis management. J Adv Nurs. 2007 Jun;58(5):418-24. doi: 10.1111/j.1365-2648.2007.04257.x. Epub 2007 Apr 17.
- Background: PubMed 11176814Kushel MB, Vittinghoff E, Haas JS. Factors associated with the health care utilization of homeless persons. JAMA. 2001 Jan 10;285(2):200-6. doi: 10.1001/jama.285.2.200.
- Background: PubMed 11988447Kushel MB, Perry S, Bangsberg D, Clark R, Moss AR. Emergency department use among the homeless and marginally housed: results from a community-based study. Am J Public Health. 2002 May;92(5):778-84. doi: 10.2105/ajph.92.5.778.
- Background: PubMed 27245948Clarke J, Proudfoot J, Ma H. Mobile Phone and Web-based Cognitive Behavior Therapy for Depressive Symptoms and Mental Health Comorbidities in People Living With Diabetes: Results of a Feasibility Study. JMIR Ment Health. 2016 May 31;3(2):e23. doi: 10.2196/mental.5131.
- Background: PubMed 26186935Nelson LA, Mulvaney SA, Gebretsadik T, Ho YX, Johnson KB, Osborn CY. Disparities in the use of a mHealth medication adherence promotion intervention for low-income adults with type 2 diabetes. J Am Med Inform Assoc. 2016 Jan;23(1):12-8. doi: 10.1093/jamia/ocv082. Epub 2015 Jul 17.
- Background: PubMed 1529093Whynes DK, MLitt BA, Giggs JA. The health of the Nottingham homeless. Public Health. 1992 Jul;106(4):307-14. doi: 10.1016/s0033-3506(05)80424-x.
- Background: PubMed 22558128Riley ED, Neilands TB, Moore K, Cohen J, Bangsberg DR, Havlir D. Social, structural and behavioral determinants of overall health status in a cohort of homeless and unstably housed HIV-infected men. PLoS One. 2012;7(4):e35207. doi: 10.1371/journal.pone.0035207. Epub 2012 Apr 25.
- Background: PubMed 25583884Emeche U. Is a strategy focused on super-utilizers equal to the task of health care system transformation? Yes. Ann Fam Med. 2015 Jan-Feb;13(1):6-7. doi: 10.1370/afm.1746. No abstract available.
- Individual participant dataSharing planned: No
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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.
Donald K McInnes, ScD principal investigator
Boston University and Department of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging in people with Chronic Disease, run by Boston University at 1 site 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 3 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 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Emergency Department Visits Made (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03034993, which also lists 24 linked publications.
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 3 May 2019.