Trial Outcomes & Findings for Uncontrolled Hypertension Among the Homeless (NCT NCT05187013)
NCT ID: NCT05187013
Last Updated: 2025-10-27
Results Overview
Systolic and diastolic blood pressure readings (SBP and DBP)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
6 months
Results posted on
2025-10-27
Participant Flow
No significant study events occurred after participant enrollment and before study assignment.
Participant milestones
| Measure |
Hypertension-Specific Education
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.
|
General Health Education
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.
|
Providers
Healthcare providers who participated in the semi-structured interview only.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
10
|
|
Overall Study
Number of Individuals Who Participated in Semi-Structured Interviews
|
13
|
7
|
10
|
|
Overall Study
COMPLETED
|
33
|
32
|
10
|
|
Overall Study
NOT COMPLETED
|
24
|
24
|
0
|
Reasons for withdrawal
| Measure |
Hypertension-Specific Education
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.
|
General Health Education
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.
|
Providers
Healthcare providers who participated in the semi-structured interview only.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
20
|
17
|
0
|
|
Overall Study
Ongoing Participants
|
3
|
5
|
0
|
Baseline Characteristics
Uncontrolled Hypertension Among the Homeless
Baseline characteristics by cohort
| Measure |
Hypertension-Specific Education
n=57 Participants
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.
|
General Health Education
n=56 Participants
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.
|
Providers
Healthcare providers and shelter staff who participated only in semi-structured interviews. No demographic data was collected for this group.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.53 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
58.05 years
STANDARD_DEVIATION 9.66 • n=7 Participants
|
—
|
57.78 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
—
|
102 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
—
|
71 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
—
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
—
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
—
|
77 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
6 Participants
n=4 Participants
|
|
Blood Pressure Baseline, Systolic, and Diastolic
Systolic Blood Pressure
|
155.772 mmHG
STANDARD_DEVIATION 12.071 • n=5 Participants
|
156.018 mmHG
STANDARD_DEVIATION 11.771 • n=7 Participants
|
—
|
155.894 mmHG
STANDARD_DEVIATION 11.871 • n=4 Participants
|
|
Blood Pressure Baseline, Systolic, and Diastolic
Diastolic Blood Pressure
|
91.263 mmHG
STANDARD_DEVIATION 10.316 • n=5 Participants
|
93.482 mmHG
STANDARD_DEVIATION 11.323 • n=7 Participants
|
—
|
92.363 mmHG
STANDARD_DEVIATION 10.836 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsSystolic and diastolic blood pressure readings (SBP and DBP)
Outcome measures
| Measure |
Hypertension-Specific Education
n=33 Participants
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.
|
General Health Education
n=32 Participants
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.
|
Providers
Healthcare providers and shelter staff who participated only in semi-structured interviews.
|
|---|---|---|---|
|
Blood Pressure
Diastolic Blood Pressure
|
89.67 mmHG
Standard Deviation 10.71
|
92.38 mmHG
Standard Deviation 82.22
|
—
|
|
Blood Pressure
Systolic Blood Pressure
|
135.36 mmHG
Standard Deviation 18.31
|
136.19 mmHG
Standard Deviation 15.68
|
—
|
PRIMARY outcome
Timeframe: Overall over 6 monthsMedication adherence was measured using the Voils 3-Item DOSE-Nonadherence measure, a 5-item Likert scale. This was measured by dichotomizing the response options such that any score of 2-5 on any of the three Extent of Non-adherence items is considered non-adherent (e.g., code as 1), and a response of 1 (none of the time) on all items is considered adherent (e.g., code as 0). The extent of adherence was then reported as a median percentage of the total participants with an IQR range as reflected below.
Outcome measures
| Measure |
Hypertension-Specific Education
n=33 Participants
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.
|
General Health Education
n=32 Participants
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.
|
Providers
Healthcare providers and shelter staff who participated only in semi-structured interviews.
|
|---|---|---|---|
|
Medication Adherence
|
83.3 Percentage of Adherent Participants
Interval 25.0 to 100.0
|
50 Percentage of Adherent Participants
Interval 0.0 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of appointments attended
Outcome measures
| Measure |
Hypertension-Specific Education
n=33 Participants
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.
|
General Health Education
n=32 Participants
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.
|
Providers
Healthcare providers and shelter staff who participated only in semi-structured interviews.
|
|---|---|---|---|
|
Appointment Attendance
|
46.08 Percentage
Standard Deviation 35.81
|
57.41 Percentage
Standard Deviation 33.51
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The number of participants interviewed from each group is below.
The number of interviews that were completed concerning participants' experiences. All data obtained are qualitative.
Outcome measures
| Measure |
Hypertension-Specific Education
n=33 Participants
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.
|
General Health Education
n=32 Participants
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.
|
Providers
n=10 Participants
Healthcare providers and shelter staff who participated only in semi-structured interviews.
|
|---|---|---|---|
|
Number of Participants Who Completed Interviews
|
13 Participants who Completed Interviews
|
6 Participants who Completed Interviews
|
10 Participants who Completed Interviews
|
Adverse Events
Hypertension-Specific Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Health Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place