SMS System for Patients With Uncontrolled Hypertension

• ClinicalTrials.gov Identifier: NCT03596242
• Recruitment Status: Completed
• First Posted: July 23, 2018
• Last Update Posted: February 17, 2022
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Other: SMS System; Behavioral: blood pressure control education	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Short Message Service System for Patients With Uncontrolled Hypertension
• Actual Study Start Date: March 9, 2021
• Actual Primary Completion Date: December 6, 2021
• Actual Study Completion Date: December 6, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: High Blood Pressure Monitoring by 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
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

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Screened [ Time Frame: baseline ]
   Number of subjects screened per month
2. Number of Subjects Enrolled [ Time Frame: baseline ]
   Number of subjects enrolled per month
3. Proportion of Eligible Subjects Enrolled [ Time Frame: baseline ]
   Proportion of qualified screened subjects who enroll into the study
4. 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
5. Proportion of subjects excluded without SMS capability [ Time Frame: baseline ]
   Proportion of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.
6. 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
7. SMS rate of response [ Time Frame: up to 12 weeks ]
   SMS rate response of at least one home BP measurement
8. SMS participation [ Time Frame: up to 12 weeks ]
   The number of patients who participate in SMS will be recorded
9. 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.

Secondary Outcome Measures :

1. Medication Adherence [ Time Frame: up to 12 weeks ]
   The number of patients who demonstrate medication compliance via SMS will be recorded.
2. Medication Adherence Questionnaire [ Time Frame: baseline, week 12 ]
   Score ranges from 0 to 10 with higher score denoting better medication adherence.
3. Monitoring of SBP [ Time Frame: up to 12 weeks ]
   Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded
4. Monitoring of DBP [ Time Frame: up to 12 weeks ]
   Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded
5. Initial and follow up BP in office [ Time Frame: up to 12 weeks ]
   Number of participants to attend initial and follow up blood pressure (systolic and diastolic) visits will be recorded.
6. No Show Rate [ Time Frame: up to 12 weeks ]
   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".
7. Coordinator time [ Time Frame: up to 12 weeks ]
   The time spent by the coordinator on study related patient activities will be recorded

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Patients who have been diagnosed with hypertension
• 18 and older
• stage 2 hypertension or greater (SBP>140 and 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 SMS capabilities will also be excluded.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Claudia Campos, MD; Wake Forest University Health Sciences

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Informed Consent Form  [PDF] November 20, 2020

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03596242
• Other Study ID Numbers: IRB00051763; 5UL1TR001420-03 ( U.S. NIH Grant/Contract )
• First Posted: July 23, 2018
• Last Update Posted: February 17, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

high blood pressure; SMS; text messaging; monitoring

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases