HypertensionNCT07693699
Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care
A study testing In-Clinic Cuff Delivery - Enhanced Return Conversation, In-Clinic Cuff Delivery - Written Instructions and Mail Order Cuff Delivery - Enhanced Return Conversation in people with Hypertension, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial summary
The goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- In-Clinic Cuff Delivery - Enhanced Return Conversation, In-Clinic Cuff Delivery - Written Instructions and Mail Order Cuff Delivery - Enhanced Return Conversation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Jul 2026to 20 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- Diagnosed hypertension documented prior to the index clinic visit.
- Scheduled for and attends an in-person visit with a participating clinician at a study clinic.
- Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP >=140 mmHg or diastolic BP >=90 mmHg.
Who cannot join
- Visit is canceled, rescheduled, or the patient does not attend the visit.
- Patient already has a usable home BP cuff provide through insurance within the past 5 years.
- Patient declines assistance obtaining a BP cuff.
- Patient declines submitting cuff order to insurance.
- Patient unable to participate for operational reasons.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Advocate Medical Group Chicago (Southeast)
Chicago, Illinois, 60617
Nicole Glowacki, MPH, 708-684-3691, nicole.glowacki@aah.org
- Recruiting
Advocate Medical Group Chicago (Imani Village)
Chicago, Illinois, 60619
Nicole Glowacki, MPH, 708-684-3691, nicole.glowacki@aah.org
- Recruiting
Advocate Medical Group Beverly
Chicago, Illinois, 60643
Nicole Glowacki, MPH, 708-684-3691, nicole.glowacki@aah.org
- Recruiting
Advocate Medical Group Merrionette Park
Merrionette Park, Illinois, 60803
Nicole Glowacki, MPH, 708-684-3691, nicole.glowacki@aah.org
- Recruiting
Advocate Medical Group Oak Lawn (FP)
Oak Lawn, Illinois, 60453
Nicole Glowacki, MPH, 708-684-3691, nicole.gowacki@aah.org
- Recruiting
Advocate Medical Group Oak Lawn (IM)
Oak Lawn, Illinois, 60453
Nicole Glowacki, MPH, 708-684-3691, nicole.glowacki@aah.org
About this study
Official title: Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial
The goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?
Read the detailed description
The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders/support, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices.
In addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials.
Patients will be randomized to one of four arms:
- Mail-order cuff delivery with enhanced return conversation
- Mail-order cuff delivery with written instructions
- In-clinic cuff distribution with enhanced return conversation
- In-clinic cuff distribution with written instructions
All other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.
- Conditions
- Hypertension
- Being tested
- In-Clinic Cuff Delivery - Enhanced Return Conversation, In-Clinic Cuff Delivery - Written Instructions, Mail Order Cuff Delivery - Enhanced Return Conversation, Mail Order Cuff Delivery - Written Instructions
- Keywords
- blood pressure cuff, blood pressure cuff delivery, blood pressure cuff instruction
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Clinic Cuff Delivery - Enhanced Return ConversationBehavioural
Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
In-Clinic Cuff Delivery - Written InstructionsBehavioural
Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
Mail Order Cuff Delivery - Enhanced Return ConversationBehavioural
Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; submit vendor form for mail delivery; complete envelope checklist.
Mail Order Cuff Delivery - Written InstructionsBehavioural
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
| Study group | Role | What they receive |
|---|---|---|
| Mail-order cuff delivery - Enhanced Return Conversation | Active comparator | Patients will receive a blood pressure cuff in the mail and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team. Receives: Behavioral: Mail Order Cuff Delivery - Enhanced Return Conversation |
| Mail-order cuff delivery - Written instructions | Active comparator | Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team. Receives: Behavioral: Mail Order Cuff Delivery - Written Instructions |
| In-clinic cuff distribution - Enhanced Return Conversation | Active comparator | Patients will receive a blood pressure cuff in the clinic and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team. Receives: Behavioral: In-Clinic Cuff Delivery - Enhanced Return Conversation |
| In-clinic cuff distribution - Written instructions | Active comparator | Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team. Receives: Behavioral: In-Clinic Cuff Delivery - Written Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Blood Pressure Receipt
Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available
Measured: up to day 14
Rate of Return Modality Completion
Number of participants that completed the assigned return modality as documented on the envelope checklist.
Measured: up to day 14
Rate of Cuff Order Completion
Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.
Measured: up to day 14
Secondary outcomes (6)
Time to Complete Intervention
Number of days from index clinic visit to documentation of both cuff receipt and completion of assigned training modality.
Measured: up to day 14
Number of Participants Documenting at Least One Blood Pressure Reading
Number of participants with at least one self-monitored blood pressure reading documented in the EHR within 21 days of cuff receipt.
Measured: up to day 21
Time Between Cuff Receipt and First Documented Reading
Number of days between cuff receipt and first documented self-monitored blood pressure reading.
Measured: up to day 21
Rate of Workflow Barriers
Number of participants with documented workflow barriers contributing to incomplete or non-concordant intervention delivery, including shipment issues, incomplete vendor forms, patient decline after workflow initiation, return modality not completed, missing documentation, clinic cuff inventory depletion, supply limitations, or other workflow disruptions identified through routine workflow documentation or operational follow-up activities.
Measured: up to day 14
Rate of Fidelity
Number of participants that received the assigned cuff delivery modality and assigned return modality without crossover, reassignment, or missing assigned workflow components.
Measured: up to day 14
Rate of Differential Implementation Success
Number of participants with successful delivery of both blood pressure cuff and return modality.
Measured: up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start30 Jul 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rasha Khatib, PhD, Principal investigator, Advocate Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693699
- Sponsor's protocol ID
- IRB00151173
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07693699
- Acronym / sponsor ID
- IRB00151173
- Conditions
- Hypertension
- Keywords
- blood pressure cuff, blood pressure cuff delivery, blood pressure cuff instruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- 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.
The goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?
Detailed description
The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders/support, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices.
In addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials.
Patients will be randomized to one of four arms:
- Mail-order cuff delivery with enhanced return conversation
- Mail-order cuff delivery with written instructions
- In-clinic cuff distribution with enhanced return conversation
- In-clinic cuff distribution with written instructions
All other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mail-order cuff delivery - Enhanced Return Conversation | Active comparator | Behavioral: Mail Order Cuff Delivery - Enhanced Return ConversationPatients will receive a blood pressure cuff in the mail and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team. |
| Mail-order cuff delivery - Written instructions | Active comparator | Behavioral: Mail Order Cuff Delivery - Written InstructionsPatients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team. |
| In-clinic cuff distribution - Enhanced Return Conversation | Active comparator | Behavioral: In-Clinic Cuff Delivery - Enhanced Return ConversationPatients will receive a blood pressure cuff in the clinic and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team. |
| In-clinic cuff distribution - Written instructions | Active comparator | Behavioral: In-Clinic Cuff Delivery - Written InstructionsPatients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Diagnosed hypertension documented prior to the index clinic visit.
- Scheduled for and attends an in-person visit with a participating clinician at a study clinic.
- Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP >=140 mmHg or diastolic BP >=90 mmHg.
Key exclusion criteria (5 listed)
- Visit is canceled, rescheduled, or the patient does not attend the visit.
- Patient already has a usable home BP cuff provide through insurance within the past 5 years.
- Patient declines assistance obtaining a BP cuff.
- Patient declines submitting cuff order to insurance.
- Patient unable to participate for operational reasons.
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 |
|---|---|---|
| In-Clinic Cuff Delivery - Enhanced Return ConversationComplete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist. | Behavioural | In-clinic cuff distribution - Enhanced Return Conversation |
| In-Clinic Cuff Delivery - Written InstructionsComplete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist. | Behavioural | In-clinic cuff distribution - Written instructions |
| Mail Order Cuff Delivery - Enhanced Return ConversationComplete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; submit vendor form for mail delivery; complete envelope checklist. | Behavioural | Mail-order cuff delivery - Enhanced Return Conversation |
| Mail Order Cuff Delivery - Written InstructionsComplete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist. | Behavioural | Mail-order cuff delivery - Written instructions |
Primary outcome
Rate of Blood Pressure Receipt
Time frame: up to day 14
Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available
Rate of Return Modality Completion
Time frame: up to day 14
Number of participants that completed the assigned return modality as documented on the envelope checklist.
Rate of Cuff Order Completion
Time frame: up to day 14
Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.
6 secondary outcomes
Time to Complete Intervention
Time frame: up to day 14
Number of Participants Documenting at Least One Blood Pressure Reading
Time frame: up to day 21
Time Between Cuff Receipt and First Documented Reading
Time frame: up to day 21
Rate of Workflow Barriers
Time frame: up to day 14
Rate of Fidelity
Time frame: up to day 14
Rate of Differential Implementation Success
Time frame: up to day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
Rasha Khatib, PhD principal investigator
Advocate Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Clinic Cuff Delivery - Enhanced Return Conversation, In-Clinic Cuff Delivery - Written Instructions and Mail Order Cuff Delivery - Enhanced Return Conversation in people with Hypertension, run by Wake Forest University Health Sciences at 6 sites 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasha Khatib, PhD (7086843691, Rasha.Alkhatib@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Blood Pressure Receipt (time frame: up to day 14). The study lists 3 primary outcomes in all. 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 12 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.