NCT03920956

Brief Summary

This study is designed to explore the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. The investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. The investigators will also survey participants regarding their experience with the service as well as conduct interviews with participating pharmacists and medical providers to understand their views and opinions on the feasibility of the service.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 24, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

April 16, 2019

Last Update Submit

February 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction with the pharmacy service and experience wearing the ABPM

    Patient satisfaction will be assessed using a 9 item survey. Participants will rate items on a 5-point scale from strongly agree to strongly disagree.

    up to 72 hours

Study Arms (1)

Experimental: 24-hour ABPM by Pharmacists

EXPERIMENTAL

Patients will meet with the pharmacist to be equipped with a 24-hour ambulatory blood pressure monitor (ABPM). Patients will return the monitor for the pharmacists to download the results to send to their medical provider.

Other: ABPM service by Pharmacists

Interventions

Patients will receive ABPM services provided by a pharmacist and complete a patient satisfaction survey

Experimental: 24-hour ABPM by Pharmacists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults greater than or equal to 18 years of age suspected by their physician of having "white coat" or "masked" hypertension (HTN), hypotension symptoms due to antihypertensive therapy, uncontrolled sustained HTN, requiring additional confirmation of an initial diagnosis if HTN, or resistant HTN.

You may not qualify if:

  • Documented past medical history of persistent atrial fibrillation, on hemodialysis, pregnancy, or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23236, United States

Location

Related Publications (1)

  • Khaddage SJ, Patterson JA, Sargent LJ, Price ET, Dixon DL. Sex and Age Differences in Ambulatory Blood Pressure Monitoring Tolerability. Am J Hypertens. 2021 Apr 20;34(4):335-338. doi: 10.1093/ajh/hpaa182.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Dave Dixon, PharmD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 19, 2019

Study Start

July 24, 2019

Primary Completion

January 24, 2020

Study Completion

January 24, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations