HypertensionAchieveBPNCT02069015
Achieving Blood Pressure Control Through Enhanced Discharge
A study testing Patient education in people with Hypertension, run by Wayne State University at 1 site in United States.
Trial summary
The primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. Enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2016
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with uncontrolled blood pressure to the emergency department (>140/90 for non-diabetics and >130/80 for diabetics)
- Self-reported history of hypertension
Who cannot join
- End-stage renal disease
- No history of hypertension
- Do not present with uncontrolled blood pressure
Trial locations and contacts
1 site in 1 country.
United States1 site
Detroit Receiving Hospital Emergency Department
Detroit, Michigan, 48201
About this study
The primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. Enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period.
Read the detailed description
A targeted sample of patients with uncontrolled blood pressure at the time of their emergency department visit discharge will be randomized into either standard or enhanced discharge. To control for medication effects in achieving blood pressure control, both groups will receive similar blood pressure medication while actively participating in the study.
- Conditions
- Hypertension
- Being tested
- Patient education
- Keywords
- Patient education, Hypertension, Patient activation
- Medical subject headings
- Hypertension, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
Patient education on hypertension delivered through a touchscreen kiosk.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced discharge | Experimental | Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge. Receives: Behavioral: Patient education |
| Standard discharge | No intervention | Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (Systolic) at 180 Days
Systolic Blood Pressure (SDB) at 180 days post-discharge
Measured: 180 days
Secondary outcomes (1)
Patient Activation Measure (PAM)
Measure of how actively involved patient is in their medical care.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionJun 2016
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Julie Gleason-Comstock, Wayne State University
- Investigators
- Julie A Gleason-Comstock, PhD, Principal investigator, Wayne State UniversityPhillip D Levy, MD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069015
- Sponsor's protocol ID
- BCBSMF 1956.11
- Acronym
- AchieveBP
- Status last verified
- Dec 2020
- First submitted
- 19 Feb 2014
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gleason-Comstock JA, Streater A, Jen KL, Artinian NT, Timmins J, Baker S, Joshua B, Paranjpe A. Consumer health information technology in an adult public health primary care clinic: a heart health education feasibility study. Patient Educ Couns. 2013 Dec;93(3):464-71. doi: 10.1016/j.pec.2013.07.010. Epub 2013 Aug 12.
PubMed 23948646Levy PD, Cline D. Asymptomatic hypertension in the emergency department: a matter of critical public health importance. Acad Emerg Med. 2009 Nov;16(11):1251-7. doi: 10.1111/j.1553-2712.2009.00512.x. Epub 2009 Oct 20.
PubMed 19845553Levy P, Ye H, Compton S, Zalenski R, Byrnes T, Flack JM, Welch R. Subclinical hypertensive heart disease in black patients with elevated blood pressure in an inner-city emergency department. Ann Emerg Med. 2012 Oct;60(4):467-74.e1. doi: 10.1016/j.annemergmed.2012.03.030. Epub 2012 May 31.
PubMed 22658278Gleason-Comstock J, Streater A, Ager J, Goodman A, Brody A, Kivell L, Paranjpe A, Vickers J, Mango L, Dawood R, Levy P. Patient education and follow-up as an intervention for hypertensive patients discharged from an emergency department: a randomized control trial study protocol. BMC Emerg Med. 2015 Dec 21;15:38. doi: 10.1186/s12873-015-0052-3.
PubMed 26691646Gleason-Comstock J, Streater A, Goodman A, Janisse J, Brody A, Mango L, Dawood R, Levy P. Willingness to pay and willingness to accept in a patient-centered blood pressure control study. BMC Health Serv Res. 2017 Aug 7;17(1):538. doi: 10.1186/s12913-017-2451-5.
PubMed 28784120Gleason Comstock J, Janisse J, Streater A, Brody A, Goodman A, Zhang L, Mango L, Dawood R, Costello W, Patton S, Paranjpe A, Welsh C, Welch R, Levy P. Efficacy of enhanced emergency department discharge for chronic hypertension management - Results of a randomized controlled trial. Contemp Clin Trials Commun. 2020 Jul 18;19:100613. doi: 10.1016/j.conctc.2020.100613. eCollection 2020 Sep.
PubMed 32743119
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Blood Pressure Control Through Enhanced Discharge
- ClinicalTrials.gov ID
- NCT02069015
- Acronym / sponsor ID
- AchieveBP / BCBSMF 1956.11
- Conditions
- Hypertension
- Keywords
- Patient education, Hypertension, Patient activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 22 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. Enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period.
Detailed description
A targeted sample of patients with uncontrolled blood pressure at the time of their emergency department visit discharge will be randomized into either standard or enhanced discharge. To control for medication effects in achieving blood pressure control, both groups will receive similar blood pressure medication while actively participating in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced discharge | Experimental | Behavioral: Patient educationPatient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge. |
| Standard discharge | No intervention | –Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Present with uncontrolled blood pressure to the emergency department (>140/90 for non-diabetics and >130/80 for diabetics)
- Self-reported history of hypertension
Key exclusion criteria (3 listed)
- End-stage renal disease
- No history of hypertension
- Do not present with uncontrolled blood pressure
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 |
|---|---|---|
| Patient educationPatient education on hypertension delivered through a touchscreen kiosk. | Behavioural | Enhanced discharge |
Primary outcome
Blood Pressure (Systolic) at 180 Days
Time frame: 180 days
Systolic Blood Pressure (SDB) at 180 days post-discharge
1 secondary outcome
Patient Activation Measure (PAM)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23948646Gleason-Comstock JA, Streater A, Jen KL, Artinian NT, Timmins J, Baker S, Joshua B, Paranjpe A. Consumer health information technology in an adult public health primary care clinic: a heart health education feasibility study. Patient Educ Couns. 2013 Dec;93(3):464-71. doi: 10.1016/j.pec.2013.07.010. Epub 2013 Aug 12.
- Background: PubMed 19845553Levy PD, Cline D. Asymptomatic hypertension in the emergency department: a matter of critical public health importance. Acad Emerg Med. 2009 Nov;16(11):1251-7. doi: 10.1111/j.1553-2712.2009.00512.x. Epub 2009 Oct 20.
- Background: PubMed 22658278Levy P, Ye H, Compton S, Zalenski R, Byrnes T, Flack JM, Welch R. Subclinical hypertensive heart disease in black patients with elevated blood pressure in an inner-city emergency department. Ann Emerg Med. 2012 Oct;60(4):467-74.e1. doi: 10.1016/j.annemergmed.2012.03.030. Epub 2012 May 31.
- Background: PubMed 26691646Gleason-Comstock J, Streater A, Ager J, Goodman A, Brody A, Kivell L, Paranjpe A, Vickers J, Mango L, Dawood R, Levy P. Patient education and follow-up as an intervention for hypertensive patients discharged from an emergency department: a randomized control trial study protocol. BMC Emerg Med. 2015 Dec 21;15:38. doi: 10.1186/s12873-015-0052-3.
- Background: PubMed 28784120Gleason-Comstock J, Streater A, Goodman A, Janisse J, Brody A, Mango L, Dawood R, Levy P. Willingness to pay and willingness to accept in a patient-centered blood pressure control study. BMC Health Serv Res. 2017 Aug 7;17(1):538. doi: 10.1186/s12913-017-2451-5.
- Results publication: PubMed 32743119Gleason Comstock J, Janisse J, Streater A, Brody A, Goodman A, Zhang L, Mango L, Dawood R, Costello W, Patton S, Paranjpe A, Welsh C, Welch R, Levy P. Efficacy of enhanced emergency department discharge for chronic hypertension management - Results of a randomized controlled trial. Contemp Clin Trials Commun. 2020 Jul 18;19:100613. doi: 10.1016/j.conctc.2020.100613. eCollection 2020 Sep.
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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.
Julie A Gleason-Comstock, PhD principal investigator
Wayne State University
Phillip D Levy, MD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Hypertension, run by Wayne State University 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 2 inclusion and 3 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 22 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2020). 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?
Blood Pressure (Systolic) at 180 Days (time frame: 180 days). 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 NCT02069015, which also lists 6 linked publications.
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 22 Dec 2020.