Hypertension
Conditions
Keywords
Hypertension, Homeless Persons, mHealth, Short message service, texting, blood pressure, medication adherence
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.
Interventions
SMS text messages sent to participants' mobile phones
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 6 months | Systolic and diastolic blood pressure readings (SBP and DBP) |
| Medication Adherence | Overall over 6 months | Medication 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. |
| Appointment Attendance | 6 months | Percentage of appointments attended |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed Interviews | 6 months | The number of interviews that were completed concerning participants' experiences. All data obtained are qualitative. |
Countries
United States
Participant flow
Pre-assignment details
No significant study events occurred after participant enrollment and before study assignment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 57 |
| 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. | 56 |
| Providers Healthcare providers and shelter staff who participated only in semi-structured interviews. No demographic data was collected for this group. | 0 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 20 | 17 | 0 |
| Overall Study | Ongoing Participants | 3 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | General Health Education | Hypertension-Specific Education | Total |
|---|---|---|---|
| Age, Continuous | 58.05 years STANDARD_DEVIATION 9.66 | 57.53 years STANDARD_DEVIATION 10.2 | 57.78 years STANDARD_DEVIATION 9.9 |
| Blood Pressure Baseline, Systolic, and Diastolic Diastolic Blood Pressure | 93.482 mmHG STANDARD_DEVIATION 11.323 | 91.263 mmHG STANDARD_DEVIATION 10.316 | 92.363 mmHG STANDARD_DEVIATION 10.836 |
| Blood Pressure Baseline, Systolic, and Diastolic Systolic Blood Pressure | 156.018 mmHG STANDARD_DEVIATION 11.771 | 155.772 mmHG STANDARD_DEVIATION 12.071 | 155.894 mmHG STANDARD_DEVIATION 11.871 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 14 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 42 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 38 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 11 Participants | 25 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 51 Participants | 51 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 1 / 56 | 0 / 10 |
| other Total, other adverse events | 0 / 57 | 0 / 56 | 0 / 10 |
| serious Total, serious adverse events | 0 / 57 | 0 / 56 | 0 / 10 |
Outcome results
Appointment Attendance
Percentage of appointments attended
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertension-Specific Education | Appointment Attendance | 46.08 Percentage | Standard Deviation 35.81 |
| General Health Education | Appointment Attendance | 57.41 Percentage | Standard Deviation 33.51 |
Blood Pressure
Systolic and diastolic blood pressure readings (SBP and DBP)
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypertension-Specific Education | Blood Pressure | Systolic Blood Pressure | 135.36 mmHG | Standard Deviation 18.31 |
| Hypertension-Specific Education | Blood Pressure | Diastolic Blood Pressure | 89.67 mmHG | Standard Deviation 10.71 |
| General Health Education | Blood Pressure | Systolic Blood Pressure | 136.19 mmHG | Standard Deviation 15.68 |
| General Health Education | Blood Pressure | Diastolic Blood Pressure | 92.38 mmHG | Standard Deviation 82.22 |
Medication Adherence
Medication 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.
Time frame: Overall over 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hypertension-Specific Education | Medication Adherence | 83.3 Percentage of Adherent Participants |
| General Health Education | Medication Adherence | 50 Percentage of Adherent Participants |
Number of Participants Who Completed Interviews
The number of interviews that were completed concerning participants' experiences. All data obtained are qualitative.
Time frame: 6 months
Population: The number of participants interviewed from each group is below.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypertension-Specific Education | Number of Participants Who Completed Interviews | 13 Participants who Completed Interviews |
| General Health Education | Number of Participants Who Completed Interviews | 6 Participants who Completed Interviews |
| Providers | Number of Participants Who Completed Interviews | 10 Participants who Completed Interviews |