Clinical trial NCT03596242: SMS System for Patients With Uncontrolled Hypertension
Official title: Short Message Service System for Patients With Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: high blood pressure
SMS
text messaging
monitoring
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-07-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Participants Screened
timeFrame: during screening period, about 6 months
measure: Number of Subjects Enrolled
timeFrame: during baseline period, about 4 months
measure: Number of Subjects Who Refuse Participation
timeFrame: baseline
measure: Number of Subjects Excluded Without SMS Capability
timeFrame: baseline
measure: Proportion of Participants Continuing myHealth
timeFrame: up to 12 weeks
measure: Number of Participants Who Responded to SMS With At Least One Home BP Measurement
timeFrame: up to 12 weeks
measure: SMS Participation
timeFrame: up to 12 weeks
measure: System Usability Scale (SUS)
timeFrame: Week 12
Secondary outcomes:
measure: Medication Adherence
timeFrame: up to 12 weeks
measure: Medication Adherence Questionnaire
timeFrame: baseline, week 12
measure: Monitoring of SBP
timeFrame: baseline and 12 weeks
measure: Monitoring of DBP
timeFrame: baseline and 12 weeks
measure: Initial and Follow up BP in Office
timeFrame: baseline/day 0 and 12 weeks
measure: Number of Participants Considered No-Shows at Clinic Visits
timeFrame: week 12
measure: Coordinator Time
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Claudia Campos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauffenburger JC, Choudhry NK. Text Messaging and Patient Engagement in an Increasingly Mobile World. Circulation. 2016 Feb 9;133(6):555-6. doi: 10.1161/CIRCULATIONAHA.116.021182. Epub 2016 Jan 14. No abstract available.
citation: Campos CL, Jones D, Snively BM, Rocco M, Pedley C, Atwater S, Moore JB. Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 May 14;10(5):e18984. doi: 10.2196/18984.