HypertensionNCT04824560

Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension

A study testing Blood pressure education in people with Hypertension, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate changes in patient knowledge of blood pressure management and perceptions of making lifestyle changes to manage their blood pressure after implementation of an evidence-based one-page teaching protocol with supplemental handouts and optional use of suggested apps and web sites. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Blood pressure education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2020to 1 Mar 2021
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults from 18 to 75 years old
Ability to self-consent
English-speaking
Able to read/write English
Currently prescribed at least one medication for treatment of essential primary hypertension

Who cannot join

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

Walgreens Store #6587
Albuquerque, New Mexico, 87112

Other trials in United States

About this study

Conditions: Hypertension
Being tested: Blood pressure education
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood pressure educationBehavioural
One page teaching protocol performed by pharmacy students; phone follow-up

Study groups in NCT04824560
Study group	Role	What they receive
BP Education	Other	All participants enrolled receive blood pressure education. Receives: Behavioral: Blood pressure education

What is being measured

The primary outcome is the main question the study is designed to answer.

Pre & Post Survey & Knowledge Test
change in participant's knowledge of blood pressure management as measured by a pre- and post-test of 10 multiple-choice questions
Measured: 8 weeks

Secondary outcomes (2)

BP Education Helpfulness
All participants enrolled receive blood pressure education; measured patient's perceived helpfulness of educational one-page handout in a post-survey
Measured: 8 weeks
BP Education - Change in Confidence in Managing Disease State (Pre & Post Survey)
change in participant's confidence in managing disease state as measured by pre \& post survey
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20201 Mar 2021

First posted1 Apr 2021
Study start1 Oct 2020
Primary completion1 Mar 2021
Study completion1 Mar 2021

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.
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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04824560
Sponsor's protocol ID: 20-458
Status last verified: Oct 2024
First submitted: 9 Mar 2021
Last updated: 25 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension
ClinicalTrials.gov ID: NCT04824560
Acronym / sponsor ID: 20-458
Conditions: Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Collaborators: University of Missouri-Columbia
Study start: 1 Oct 2020 (actual)
Primary completion: 1 Mar 2021 (actual)
Study completion: 1 Mar 2021 (actual)
First posted: 1 Apr 2021 (actual)
Results: Posted 25 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BP Education	Other	Behavioral: Blood pressure educationAll participants enrolled receive blood pressure education.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults from 18 to 75 years old
Ability to self-consent
English-speaking
Able to read/write English
Currently prescribed at least one medication for treatment of essential primary hypertension

Key exclusion criteria (4 listed)

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners

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
Blood pressure educationOne page teaching protocol performed by pharmacy students; phone follow-up	Behavioural	BP Education

Primary outcome

Pre & Post Survey & Knowledge Test
Time frame: 8 weeks
change in participant's knowledge of blood pressure management as measured by a pre- and post-test of 10 multiple-choice questions

2 secondary outcomes

BP Education Helpfulness
Time frame: 8 weeks
BP Education - Change in Confidence in Managing Disease State (Pre & Post Survey)
Time frame: 8 weeks

Results and safety

Results posted to the registry on 25 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BP Education	17	5

Primary outcome: Pre & Post Survey & Knowledge Test

Time frame: 8 weeks. Mean (Full Range). Unit: percentage of questions answered correct

Measure	BP Education n = 5
Pre-Test Knowledge Score	85 (70 to 100)
Post-Test Knowledge Score	100 (100 to 100)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: After enrollment, packet was mailed to participant and future phone call time frames set up to be able to call the participants back for an initial call to ensure packet received within one week of enrollment; with follow-up at 4 weeks after enrollment, 8 weeks after enrollment, and then a final phone call to ensure information would be mailed back at up to 4 weeks after the final phone call.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BP Education	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypertension

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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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 Blood pressure education in people with Hypertension, run by University of New Mexico 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 5 inclusion and 4 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 25 Nov 2024. 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 25 Nov 2024). 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?

Pre & Post Survey & Knowledge Test (time frame: 8 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 NCT04824560.

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 25 Nov 2024.