SMS System for Patients With Uncontrolled Hypertension

Hypertension Clinical Trial

Official title:

Short Message Service System for Patients With Uncontrolled Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596242
• Other study ID #: IRB00051763
• Secondary ID: 5UL1TR001420-03
• Status: Completed
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: March 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Screened		during screening period, about 6 months
Primary	Number of Subjects Enrolled		during baseline period, about 4 months
Primary	Number of Subjects Who Refuse Participation	number of participants who refuse to participate at the time of recruitment and the reason why	baseline
Primary	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
Primary	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
Primary	Number of Participants Who Responded to SMS With At Least One Home BP Measurement		up to 12 weeks
Primary	SMS Participation	The number of patients who participate in SMS will be recorded	up to 12 weeks
Primary	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	Medication Adherence	The number of patients who demonstrate medication compliance via SMS will be recorded.	up to 12 weeks
Secondary	Medication Adherence Questionnaire	Score ranges from 0 to 10 with higher score denoting better medication adherence.	baseline, week 12
Secondary	Monitoring of SBP	Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded	baseline and 12 weeks
Secondary	Monitoring of DBP	Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded	baseline and 12 weeks
Secondary	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
Secondary	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
Secondary	Coordinator Time	The time spent by the coordinator on study related patient activities will be recorded	up to 12 weeks