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Completed

NCT Number: NCT03596242

SMS 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMS System

Other

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

blood pressure control education

Behavioral

standard blood pressure control education given during visits

Primary outcomes

  1. Number of Participants Screened

    Time frame: during screening period, about 6 months

  2. Number of Subjects Enrolled

    Time frame: during baseline period, about 4 months

  3. 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

  4. Number of Subjects Excluded Without SMS Capability

    Time frame: baseline

    Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.

  5. 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

  6. Number of Participants Who Responded to SMS With At Least One Home BP Measurement

    Time frame: up to 12 weeks

  7. SMS Participation

    Time frame: up to 12 weeks

    The number of patients who participate in SMS will be recorded

  8. 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 (better) usability.

Secondary outcomes

  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: baseline and 12 weeks

    Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded

  4. Monitoring of DBP

    Time frame: baseline and 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: baseline/day 0 and 12 weeks

    Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded.

  6. Number of Participants Considered No-Shows at Clinic Visits

    Time frame: week 12

    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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Short Message Service System for Patients With Uncontrolled Hypertension

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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