HypertensionNCT02664610
Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)
A study testing Text Messaging in people with Hypertension and Stroke, run by University of Michigan.
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 significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- 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
- 94 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 y/o) participants with BP ≥140/90 who have mobile phones with text-messaging capability.
Who cannot join
- Adult who is illiterate, non-English speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 months unlikely.
About this study
Official title: REACH OUT: to Reduce High Blood Pressure
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 significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor.
This proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban African American community in Flint, Michigan.
Read the detailed description
This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.
- 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
hypertensive participants will be randomized to receive tailored, motivational text messages
| Study group | Role | What they receive |
|---|---|---|
| No text messages, hypertensive | No intervention | Participants who have high blood pressure, who are randomized to health information (do not receive text messages). |
| Text messages, hypertensive | Experimental | Participants who have high blood pressure, who are randomized to receive text messages. Receives: Behavioral: Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Systolic Blood Pressure
Measured: Baseline to 6 months
Secondary outcomes (1)
Mean Change in Diastolic Blood Pressure
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 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
- Investigators
- Lesli Skolarus, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664610
- Sponsor's protocol ID
- GO13884
- Status last verified
- May 2023
- First submitted
- 6 Oct 2015
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH OUT: to Reduce High Blood Pressure
- ClinicalTrials.gov ID
- NCT02664610
- Acronym / sponsor ID
- GO13884
- Conditions
- Hypertension, Stroke
- Keywords
- hypertension treatment, stroke prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 17 Jul 2017
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 significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor.
This proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban African American community in Flint, Michigan.
Detailed description
This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No text messages, hypertensive | No intervention | –Participants who have high blood pressure, who are randomized to health information (do not receive text messages). |
| Text messages, hypertensive | Experimental | Behavioral: Text MessagingParticipants who have high blood pressure, who are randomized to receive text messages. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (>18 y/o) participants with BP ≥140/90 who have mobile phones with text-messaging capability.
Key exclusion criteria (1 listed)
- Adult who is illiterate, non-English speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 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 Messaginghypertensive participants will be randomized to receive tailored, motivational text messages | Behavioural | Text messages, hypertensive |
Primary outcome
Mean Change in Systolic Blood Pressure
Time frame: Baseline to 6 months
1 secondary outcome
Mean Change in Diastolic Blood Pressure
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lesli Skolarus principal investigator
University of Michigan
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.
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 1 inclusion and 1 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 17 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Systolic Blood Pressure (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2023.