SMS System for Patients With Uncontrolled Hypertension

Study Overview
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Brief Summary
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This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital.

Detailed Description
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The pilot will evaluate the feasibility of implementing a Short Message Service (SMS) system and Home Blood Pressure Measurements (HBPM) in the Outpatient Internal Medicine (OPD) clinic at Wake Forest Baptist Hospital. Implementing a new short text messaging service will improve the health delivery system in three ways. 1) Increasing patient engagement: SMS and HBPM require an active commitment by the patients themselves in their medical care and results in a marked improvement in the adherence to medication. High adherence to home blood pressure (BP) measurements has also been reported to improve BP control. 2) Supporting patients outside of the office visits by identifying and resolving barriers to medication adherence earlier on (i.e. if patients are unable to get their prescriptions or are having significant side effects). 3) Adopting clinical guidelines to improve BP control in a vulnerable population.

Official Title
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Short Message Service System for Patients With Uncontrolled Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Other: SMS System
* Behavioral: blood pressure control education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been diagnosed with hypertension 18 and older stage 2 hypertension or greater systolic blood pressure [(SBP)>140 and diastolic blood pressure (DBP) >90] who are receiving antihypertensive treatment. Exclusion Criteria: Pregnancy end-stage renal disease (on hemodialysis or peritoneal dialysis) hospice or nursing home care dementia Patients who do not have a phone with Short Message Service (SMS) capabilities will also be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Blood Pressure Monitoring by Short Message Service (SMS)<br>Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits | Other: SMS System<br>* Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence<br>Behavioral: blood pressure control education<br>* standard blood pressure control education given during visits<br>|
| Active Comparator: Usual Care Plus Standard Blood Pressure Monitoring<br>Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits | Behavioral: blood pressure control education<br>* standard blood pressure control education given during visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Screened |  | during screening period, about 6 months | 
| Number of Subjects Enrolled |  | during baseline period, about 4 months | 
| Number of Subjects Who Refuse Participation | number of participants who refuse to participate at the time of recruitment and the reason why | baseline | 
| Number of Subjects Excluded Without SMS Capability | Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability. | baseline | 
| Proportion of Participants Continuing myHealth | the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention | up to 12 weeks | 
| Number of Participants Who Responded to SMS With At Least One Home BP Measurement |  | up to 12 weeks | 
| SMS Participation | The number of patients who participate in SMS will be recorded | up to 12 weeks | 
| System Usability Scale (SUS) | Participants will complete the SUS in person on an I-Pad or over the phone. The SUS yields a single score on a scale of 0-100. A SUS score above a 68 would be considered above average (better) usability. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | The number of patients who demonstrate medication compliance via SMS will be recorded. | up to 12 weeks | 
| Medication Adherence Questionnaire | Score ranges from 0 to 10 with higher score denoting better medication adherence. | baseline, week 12 | 
| Monitoring of SBP | Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded | baseline and 12 weeks | 
| Monitoring of DBP | Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded | baseline and 12 weeks | 
| Initial and Follow up BP in Office | Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded. | baseline/day 0 and 12 weeks | 
| Number of Participants Considered No-Shows at Clinic Visits | No-show rate at 3 months' follow-up (f/u) clinic visits. If participants fail to come to their f/u visits within 7 days of their scheduled follow-up appointment, they will be considered as no- shows. | week 12 | 
| Coordinator Time | The time spent by the coordinator on study related patient activities will be recorded | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high blood pressure, SMS, text messaging, monitoring