SMS System for Patients With Uncontrolled Hypertension

Short Message Service System for Patients With Uncontrolled Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: SMS System; Behavioral: blood pressure control education

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care Plus Standard Blood Pressure Monitoring; Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits	Behavioral: blood pressure control education; standard blood pressure control education given during visits
Experimental: High Blood Pressure Monitoring by Short Message Service (SMS); 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; Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence; Behavioral: blood pressure control education; standard blood pressure control education given during visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Claudia Campos, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): December 6, 2021

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: text messaging; SMS; monitoring; high blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB00051763; 5UL1TR001420-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No