NCT04577131

Brief Summary

The purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

September 30, 2020

Last Update Submit

January 12, 2021

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Change in adherence to home blood pressure monitoring

    Proportion of days blood pressure is measured based on data from the blood pressuring monitor

    1 month

  • Change in proportion of participants with a blood pressure <130/80 mm Hg.

    Proportion of participants with a blood pressure \<130/80 mm Hg.

    1 month

Study Arms (2)

With check-ins

EXPERIMENTAL

Daily blood pressure monitoring with weekly check-ins

Behavioral: Weekly check-in

Without check-ins

NO INTERVENTION

Daily blood pressure monitoring without weekly check-ins

Interventions

Weekly check-inBEHAVIORAL

Weekly check-in phone calls from a pharmacist to review blood pressures and the number of times tested in that week

With check-ins

Eligibility Criteria

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

You may qualify if:

  • years of age and older
  • Uncontrolled hypertension (BP \> 130/80 mm Hg)

You may not qualify if:

  • non-English speaking patients
  • patients without a mobile phone or texting capability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

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
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 6, 2020

Study Start

November 5, 2020

Primary Completion

November 5, 2020

Study Completion

November 5, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)