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Uncontrolled Hypertension Among the Homeless

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth for Hypertension in Homeless Persons
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Hypertension, Homeless Persons, mHealth, Short message service, texting, blood pressure, medication adherence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently experiencing homelessness
  • Current diagnosis of hypertension
  • SBP above 140mmHg or DBP above 90mmHg at most recent clinic visit
  • English or Spanish speaking
  • Currently presenting to Project Renewal shelter-clinics for medical care
  • Connected to multidisciplinary social and health services at Project Renewal

Exclusion Criteria:

  • Pregnant or within 3 months post-partum
  • Heart attack or stroke within previous 6 months
  • History of aortic aneurysm
  • Diagnosis of end-stage renal disease or currently on dialysis
  • Inability to read or respond to SMS texts
  • Any condition preventing participants from providing informed consent
  • SBP >175mmHg or DBP >105mmHg unless medical provider determines patient has no symptoms suggesting a hypertensive emergency or urgency

Sites / Locations

  • George Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hypertension-Specific Education

General Health Education

Arm Description

6 months of mHealth HTN management support via SMS texts including reminders for medication adherence, appointment attendance, and HTN-specific health education and support. Texts will be delivered to support medication adherence and lifestyle changes, and participants will receive appointment reminders before each appointments with a follow-up text and robocall if the appointment is missed.

6 months of mHealth including basic healthcare and general health promotion via SMS texts. Blood pressure measurements and adherence assessments will be collected at every shelter visit.

Outcomes

Primary Outcome Measures

Blood pressure
Systolic and diastolic blood pressure readings (SBP and DBP)
Medication adherence
Voils 3 Item DOSE-Nonadherence measure
Appointment attendance
Percentage of appointments attended

Secondary Outcome Measures

Attitude, acceptance and experience of the intervention
Interview answers concerning participants experiences.

Full Information

First Posted
December 7, 2021
Last Updated
September 8, 2023
Sponsor
George Washington University
Collaborators
New York University, National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05187013
Brief Title
Uncontrolled Hypertension Among the Homeless
Official Title
mHealth to Address Uncontrolled Hypertension Among Hypertensive Homeless Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
New York University, National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to assess the effect of implementing a mobile health (mHealth) strategy using text messaging for hypertension (HTN) management among hypertensive homeless persons with uncontrolled blood pressure age 21 or older in shelter-clinics in New York City (NYC). The study uses a randomized clinical trial design (homeless, n=120) and semi-structured interviews (homeless, n=30; providers, n=20). The control group will receive text messages for usual standard care/healthy lifestyle during a 6-month follow-up period. The intervention group will receive text messages geared towards both standard care/healthy lifestyle and blood pressure control. At the end of study period, the investigators will assess changes in blood pressure (BP) measurements, adherence to clinic visits, and adherence to medication, and the investigators will compare them between the two groups. Qualitative interviews with both patients and providers who provide services to the homeless in shelter settings will develop a better understand barriers and opportunities regarding BP control. The investigators hypothesize that those individuals randomized to the intervention will experience a reduction in blood pressure (8mmHg systolic BP or diastolic BP) and will exhibit better adherence to blood pressure medications and appointments compared to the control group.
Detailed Description
Project Renewal operates several urban shelters in five boroughs of NYC. Enrollment, data collection, and retention will be supported at these sites. Patient participants will be recruited in clinics via medical record reviews and will be randomly assigned to treatment groups using a computer-assisted permuted randomization schedule with a block size of four, stratified by clinic site, severe mental illness, and active substance use disorder. Provider participants are physicians, nurse practitioners, social workers, and counselors working at Project Renewal. The intervention will include 6 months of mHealth HTN management support via short message service (SMS) texts including reminders for medication adherence, appointment attendance, and HTN-specific health education and support. Texts will be delivered to support medication adherence and lifestyle changes, and participants will receive appointment reminders before each appointments. The control group will receive 6 months of mHealth including basic healthcare and general health promotion via SMS texts on the same schedule as the intervention group. Both groups will undergo BP measurements and adherence assessments at appointments in the shelter-clinics. All texts will be interactive and reciprocal; during the study, feedback to SMS texts, including automated and reciprocal feedback for patient-specific input, will be directly provided to patients to enhance education and behavioral changes. Primary outcome measures will be recorded at 0, 2, 4, and 6 months, and secondary outcome measures will be collected throughout the study. Qualitative interviews with persons experiencing homelessness with HTN (n=30, 15 each arm) and providers (n=20) will be conducted at the end of the recruitment period. Trained research assistants (RA) will collect data and perform the semi-structured interviews. During clinic visits, BP will be measured by trained clinic nurses in a seated upright position on the right arm with a properly sized cuff. Two readings will be taken at 2-minute intervals following 5 minutes of rest and will be averaged and recorded. Proportion of days covered (PDC) and pill counts will be conducted at each visit. Additional information, including appointment attendance, will be collected from the medical record.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Homeless Persons, mHealth, Short message service, texting, blood pressure, medication adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypertension-Specific Education
Arm Type
Experimental
Arm Description
6 months of mHealth HTN management support via SMS texts including reminders for medication adherence, appointment attendance, and HTN-specific health education and support. Texts will be delivered to support medication adherence and lifestyle changes, and participants will receive appointment reminders before each appointments with a follow-up text and robocall if the appointment is missed.
Arm Title
General Health Education
Arm Type
Other
Arm Description
6 months of mHealth including basic healthcare and general health promotion via SMS texts. Blood pressure measurements and adherence assessments will be collected at every shelter visit.
Intervention Type
Behavioral
Intervention Name(s)
mHealth for Hypertension in Homeless Persons
Intervention Description
SMS text messages sent to participants' mobile phones
Primary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic blood pressure readings (SBP and DBP)
Time Frame
6 months
Title
Medication adherence
Description
Voils 3 Item DOSE-Nonadherence measure
Time Frame
6 months
Title
Appointment attendance
Description
Percentage of appointments attended
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Attitude, acceptance and experience of the intervention
Description
Interview answers concerning participants experiences.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently experiencing homelessness Current diagnosis of hypertension SBP above 140mmHg or DBP above 90mmHg at most recent clinic visit English or Spanish speaking Currently presenting to Project Renewal shelter-clinics for medical care Connected to multidisciplinary social and health services at Project Renewal Exclusion Criteria: Pregnant or within 3 months post-partum Heart attack or stroke within previous 6 months History of aortic aneurysm Diagnosis of end-stage renal disease or currently on dialysis Inability to read or respond to SMS texts Any condition preventing participants from providing informed consent SBP >175mmHg or DBP >105mmHg unless medical provider determines patient has no symptoms suggesting a hypertensive emergency or urgency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramin Asgary, MD, MPH
Phone
202-994-6803
Email
raminasgary1@gwu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leah J Bauder, MPH
Phone
970-682-0940
Email
leahbaud@gwmail.gwu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramin Asgary, MD, MPH
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramin Asgary, MD
Email
raminasgary1@gwu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Uncontrolled Hypertension Among the Homeless

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