NCT02301455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

October 23, 2014

Last Update Submit

February 7, 2018

Conditions

Keywords

hypertension treatmentstroke prevention

Outcome Measures

Primary Outcomes (1)

  • Proportion of people who respond to text messages and are persistently hypertensive

    3 weeks

Secondary Outcomes (4)

  • Change in systolic and diastolic blood pressure

    4 months

  • Feasibility of a screening algorithm

    4 months

  • Feasibility of subject follow-up mechanism

    4 months

  • Mean group differences and standard deviations for systolic blood pressure

    4 months

Study Arms (3)

Control, Not hypertensive

NO INTERVENTION

Participants who after 3 weeks do not have high blood pressure or are not responsive to text messages.

Text messages, hypertensive

EXPERIMENTAL

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

No text messages, hypertensive

NO INTERVENTION

Participants who after 3 weeks have high blood pressure and are responsive to text messages, who are then randomized to not receive text messages.

Interventions

Text messagingBEHAVIORAL

persistently hypertensive participants will be randomized to receive these tailored, motivational text messages

Text messages, hypertensive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ann Arbor, Michigan, United States

Location

Related Publications (1)

  • Meurer WJ, Dome M, Brown D, Delemos D, Oska S, Gorom V, Skolarus L. Feasibility of Emergency Department-initiated, Mobile Health Blood Pressure Intervention: An Exploratory, Randomized Clinical Trial. Acad Emerg Med. 2019 May;26(5):517-527. doi: 10.1111/acem.13691. Epub 2019 Feb 19.

MeSH Terms

Conditions

HypertensionStroke

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 26, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations