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SMS System for Patients With Uncontrolled Hypertension

Not Applicable
Completed
Conditions
Hypertension
Interventions
Other: SMS System
Behavioral: blood pressure control education
Registration Number
NCT03596242
Lead Sponsor
Wake Forest University Health Sciences
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
High Blood Pressure Monitoring by Short Message Service (SMS)blood pressure control educationWill 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
Usual Care Plus Standard Blood Pressure Monitoringblood pressure control educationWill receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
High Blood Pressure Monitoring by Short Message Service (SMS)SMS SystemWill 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
Primary Outcome Measures
NameTimeMethod
Number of Participants Screenedduring screening period, about 6 months
Number of Subjects Excluded Without SMS Capabilitybaseline

Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.

Proportion of Participants Continuing myHealthup to 12 weeks

the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention

SMS Participationup to 12 weeks

The number of patients who participate in SMS will be recorded

System Usability Scale (SUS)Week 12

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.

Number of Subjects Enrolledduring baseline period, about 4 months
Number of Subjects Who Refuse Participationbaseline

number of participants who refuse to participate at the time of recruitment and the reason why

Number of Participants Who Responded to SMS With At Least One Home BP Measurementup to 12 weeks
Secondary Outcome Measures
NameTimeMethod
Medication Adherenceup to 12 weeks

The number of patients who demonstrate medication compliance via SMS will be recorded.

Medication Adherence Questionnairebaseline, week 12

Score ranges from 0 to 10 with higher score denoting better medication adherence.

Number of Participants Considered No-Shows at Clinic Visitsweek 12

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".

Monitoring of DBPbaseline and 12 weeks

Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded

Initial and Follow up BP in Officebaseline/day 0 and 12 weeks

Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded.

Coordinator Timeup to 12 weeks

The time spent by the coordinator on study related patient activities will be recorded

Monitoring of SBPbaseline and 12 weeks

Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

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