SMS System for Patients With Uncontrolled Hypertension

NCT03596242 | Completed Results

• 2 other identifiers: IRB000517635UL1TR001420-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

high blood pressure; SMS; text messaging; monitoring

Outcome Measures

Primary Outcomes (8)

• 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

• 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 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 Outcomes (7)

• Medication Adherence

  up to 12 weeks

• Medication Adherence Questionnaire

  baseline, week 12

• Monitoring of SBP

  baseline and 12 weeks

• Monitoring of DBP

  baseline and 12 weeks

• Initial and Follow up BP in Office

  baseline/day 0 and 12 weeks

Study Arms (2)

High Blood Pressure Monitoring by Short Message Service (SMS)

EXPERIMENTAL

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; Behavioral: blood pressure control education

Usual Care Plus Standard Blood Pressure Monitoring

ACTIVE COMPARATOR

Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits

Behavioral: blood pressure control education

Interventions

SMS System OTHER

Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence

High Blood Pressure Monitoring by Short Message Service (SMS)

blood pressure control education BEHAVIORAL

standard blood pressure control education given during visits

High Blood Pressure Monitoring by Short Message Service (SMS); Usual Care Plus Standard Blood Pressure Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been diagnosed with hypertension
• and older
• stage 2 hypertension or greater systolic blood pressure \[(SBP)\>140 and diastolic blood pressure (DBP) \>90\] who are receiving antihypertensive treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• 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.

  PMID: 26769741 BACKGROUND

• 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.

  PMID: 33988513 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Claudia L. Campos, MD
• Organization: Wake Forest School of Medicine

ccampos@wakehealth.edu

ccampos@wakehealth.edu

Study Officials

• Claudia Campos, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: March 9, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)