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Trial record 5 of 662 for:    SMS

SMS System for Patients With Uncontrolled Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03596242
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : October 2, 2019
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Short Message Service System for Patients With Uncontrolled Hypertension
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: High Blood Pressure Monitoring by SMS
Participants will have their high blood pressure monitored by a SMS system
Other: SMS System
Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence

Primary Outcome Measures :
  1. SMS participation [ Time Frame: up to 12 weeks ]
    The number of patients who participate in SMS will be recorded

  2. Medication adherence [ Time Frame: up to 12 weeks ]
    The number of patients who demonstrate medication compliance via SMS will be recorded.

  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. Satisfaction assessed by the system usability scale [ Time Frame: Week 12 ]
    Survey results demonstrating acceptability of self-monitoring and SMS texting or clinic. The score range is 1-15 with lower scores denoting better outcomes.

  5. Monitoring of DBP [ Time Frame: up to 12 weeks ]
    Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded

Secondary Outcome Measures :
  1. 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.

  2. Coordinator time [ Time Frame: up to 12 weeks ]
    The time spent by the coordinator on study related patient activities will be recorded

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03596242

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Contact: Nickie Jackson 336-713-7362
Contact: Claudia Campos, MD 336-713-9745

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United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Nickie N Jackson, BS    336-713-7362   
Principal Investigator: Claudia L Campos, MD         
Sub-Investigator: Deanna Jones, MD         
Sub-Investigator: Justin Moore, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: Claudia Campos, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences Identifier: NCT03596242     History of Changes
Other Study ID Numbers: IRB00051763
5UL1TR001420-03 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
text messaging
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases