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REACH OUT: to Reduce High Blood Pressure in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02301455
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Lesli E. Skolarus, MD, University of Michigan

Brief Summary:

One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition.

Hypertension is very prevalent in the emergency department (ED), but significantly undertreated. The overall goal of this project is to develop a text messaging intervention to improve hypertension care in the ED. This will first be done by testing the feasibility of identifying hypertensive patients in the ED, and the response rate to text messages.


Condition or disease Intervention/treatment Phase
Hypertension Stroke Behavioral: Text messaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control, Not hypertensive
Participants who after 3 weeks do not have high blood pressure or are not responsive to text messages.
Experimental: Text messages, hypertensive
Participants who after 3 weeks have high blood pressure and are responsive to text messages, who are then randomized to receive text messages.
Behavioral: Text messaging
persistently hypertensive participants will be randomized to receive these tailored, motivational text messages

No Intervention: No text messages, hypertensive
Participants who after 3 weeks have high blood pressure and are responsive to text messages, who are then randomized to not receive text messages.



Primary Outcome Measures :
  1. Proportion of people who respond to text messages and are persistently hypertensive [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Change in systolic and diastolic blood pressure [ Time Frame: 4 months ]
  2. Feasibility of a screening algorithm [ Time Frame: 4 months ]
    Proportion of subjects recruited compared to proportion of subjects approached. Subject eligibility identified by screening algorithm.

  3. Feasibility of subject follow-up mechanism [ Time Frame: 4 months ]
    Proportion of subjects responding to follow-up text messages

  4. Mean group differences and standard deviations for systolic blood pressure [ Time Frame: 4 months ]


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
Criteria

Inclusion Criteria:

  • Adult (≥18 y/o)
  • At least one BP of systolic blood pressure (SBP) ≥160 or a diastolic blood pressure (DBP) ≥100 or only BP performed prior to enrollment is SBP ≥160 or a DBP ≥100 (If the patient has repeated measurements after achieving Criteria 1, but prior to being enrolled, at least one of the repeat BP remains SBP ≥140 or a DBP ≥90)
  • Must have mobile phones with text-messaging capability
  • Likely to be discharged from the ED

Exclusion Criteria:

  • Adult who is in an urgent condition
  • Unable to read
  • Non-English speaking
  • Incarcerated/ institutionalized resident
  • Pregnant, or has a pre-existing condition that makes follow-up for 4 months unlikely.

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 ClinicalTrials.gov identifier (NCT number): NCT02301455


Locations
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United States, Michigan
Ann Arbor, Michigan, United States
Sponsors and Collaborators
University of Michigan

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Responsible Party: Lesli E. Skolarus, MD, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02301455     History of Changes
Other Study ID Numbers: HUM00091668
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by Lesli E. Skolarus, MD, University of Michigan:
hypertension treatment
stroke prevention

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases