HypertensionNCT02301455
REACH OUT: to Reduce High Blood Pressure in the Emergency Department
A study testing Text messaging in people with Hypertension and Stroke, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Stroke
- What is being tested?
- Text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypertension, Stroke
- Being tested
- Text messaging
- Keywords
- hypertension treatment, stroke prevention
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingBehavioural
persistently hypertensive participants will be randomized to receive these tailored, motivational text messages
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of people who respond to text messages and are persistently hypertensive
Measured: 3 weeks
Secondary outcomes (4)
Change in systolic and diastolic blood pressure
Measured: 4 months
Feasibility of a screening algorithm
Proportion of subjects recruited compared to proportion of subjects approached. Subject eligibility identified by screening algorithm.
Measured: 4 months
Feasibility of subject follow-up mechanism
Proportion of subjects responding to follow-up text messages
Measured: 4 months
Mean group differences and standard deviations for systolic blood pressure
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesli E. Skolarus, MD, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301455
- Sponsor's protocol ID
- HUM00091668
- Status last verified
- Feb 2018
- First submitted
- 23 Oct 2014
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30659702
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH OUT: to Reduce High Blood Pressure in the Emergency Department
- ClinicalTrials.gov ID
- NCT02301455
- Acronym / sponsor ID
- HUM00091668
- Conditions
- Hypertension, Stroke
- Keywords
- hypertension treatment, stroke prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Text messagingParticipants who after 3 weeks have high blood pressure and are responsive to text messages, who are then randomized to receive text messages. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text messagingpersistently hypertensive participants will be randomized to receive these tailored, motivational text messages | Behavioural | Text messages, hypertensive |
Primary outcome
Proportion of people who respond to text messages and are persistently hypertensive
Time frame: 3 weeks
4 secondary outcomes
Change in systolic and diastolic blood pressure
Time frame: 4 months
Feasibility of a screening algorithm
Time frame: 4 months
Feasibility of subject follow-up mechanism
Time frame: 4 months
Mean group differences and standard deviations for systolic blood pressure
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Derived from this study: PubMed 30659702Meurer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messaging in people with Hypertension and Stroke, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of people who respond to text messages and are persistently hypertensive (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.