Antihypertensive Self-titration in US Primary Care

NCT07869966 — Not applicable, Not yet recruiting, 30 participants, Brigham and Women's Hospital

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Registry	NCT07869966
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	30 (Estimated)
Sponsor	Brigham and Women's Hospital (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Hypertension
Interventions	Self-Titration (Other)
Dates	start 2027-02-01 (estimated), primary completion 2027-08-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-10-13, last updated 2026-10-13
Locations	1 site in United States

-Summary

The objective of this study is to pilot test self-titration intervention procedures. We are testing a new way to manage high blood pressure from home. In this study, patients will check their blood pressure at home and take steps to adjust their blood pressure medications if needed, following a plan outlined with a primary care doctor. Participation in this study will last up to 6 months.

Participation will include a research visit to review the blood pressure management process. A primary care provider will also develop a medication plan for each participant to follow during the study and address any questions at their upcoming visit. During the study, each participant will be asked to check their blood pressure at home every day for 1-2 weeks a month using a study-provided blood pressure cuff. They will be asked to follow a set of instructions to request a medication change from their provider, based on their blood pressure readings. Participation may also include lab visits and additional visits with a primary care physician before making medication changes, if needed. There will also be a follow-up visit within 6 months.

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+Arms and interventions

Arm	Type	Interventions	Description
Self-Titration	Experimental	Other: Self-Titration

Self-Titration (Other): Following consent, patients will complete a brief baseline questionnaire, including questions about blood pressure knowledge. Staff will ensure that the patient has a validated BP cuff for home use, teach them how to use it, calibrate the cuff, and test entering values. Patients will proceed through the self-titration process for 6 months.

+Outcome measures

Primary outcomes

Change in BP (blood pressure) [180 days]: Change in BP between baseline and 6 months in intervention vs. usual care

Secondary outcomes

Healthcare Utilization [180 days]: Outpatient visits, ED visits, hospitalizations, portal messages, phone calls
Side Effects and Adverse Events [180 days]: Common side effects and adverse events

Other outcomes

BP Knowledge [180 days]: Hypertension knowledge scale

+Eligibility

Sex: All, ages: 35 Years to any

Inclusion Criteria:

* Age ≥35 years
* Prescribed 1 or 2 antihypertensives
* Average of last 3 BPs > 130/80 (home \& clinic)
* Upcoming scheduled PCP visit
* Averaged BP >130/80 at nurse visit

Exclusion Criteria:

* Unable to read English or Spanish
* Unable to self-monitor (by nurse assessment)
* Dementia or significant cognitive impairment (nurse / PCP discretion)
* Pregnant or actively seeking to become pregnant
* Terminal diagnosis or hospice
* Family member already participating in the trial

+Locations (1)

Facility	City	Country	Status
Mass General Brigham	Somerville, Massachusetts	United States

+Funding

NIH grants: R34HL178960