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Clinical Trials/NCT03596242
NCT03596242
Completed
Not Applicable

Short Message Service System for Patients With Uncontrolled Hypertension

Wake Forest University Health Sciences1 site in 1 country24 target enrollmentMarch 9, 2021
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Wake Forest University Health Sciences
Enrollment
24
Locations
1
Primary Endpoint
Number of Participants Screened
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2021
End Date
December 6, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Patients who do not have a phone with Short Message Service (SMS) capabilities will also be excluded.

Outcomes

Primary Outcomes

Number of Participants Screened

Time Frame: during screening period, about 6 months

Number of Subjects Excluded Without SMS Capability

Time Frame: baseline

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

Proportion of Participants Continuing myHealth

Time Frame: up 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 Participation

Time Frame: up to 12 weeks

The number of patients who participate in SMS will be recorded

System Usability Scale (SUS)

Time Frame: 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 Enrolled

Time Frame: during baseline period, about 4 months

Number of Subjects Who Refuse Participation

Time Frame: baseline

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 Measurement

Time Frame: up to 12 weeks

Secondary Outcomes

  • Medication Adherence(up to 12 weeks)
  • Medication Adherence Questionnaire(baseline, week 12)
  • Number of Participants Considered No-Shows at Clinic Visits(week 12)
  • Monitoring of DBP(baseline and 12 weeks)
  • Initial and Follow up BP in Office(baseline/day 0 and 12 weeks)
  • Coordinator Time(up to 12 weeks)
  • Monitoring of SBP(baseline and 12 weeks)

Study Sites (1)

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