NCT04275934

Brief Summary

The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 14, 2020

Last Update Submit

February 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood Pressure Control

    Management of Systolic and Diastolic Blood Pressure Measures

    6-months

  • Blood Pressure Change

    Systolic and Diastolic Blood Pressure Measure Changes

    6-months

Secondary Outcomes (4)

  • Blood Pressure Medication Adherence

    6-months

  • Health Care Utilization of Primary Care Services

    6-months

  • Health Care Utilization of Emergency Department Services

    6-months

  • Health Care Utilization of Hospital Services

    6-months

Study Arms (1)

Cohort

This project will evaluate the impact of self-insured employers implementing an innovative care model utilizing pharmacist-delivered MTM services for health plan beneficiaries with high blood pressure.

Behavioral: Health Management; Blood Pressure

Interventions

Pharmacists will work with the patient/study subject, referred to as the participant hereafter, and the participant's other health care providers to manage their blood pressure, making recommendations for medication and lifestyle adjustments as needed.

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Beneficiaries of self-insured employer who may benefit from patient-centered, team-based care that supports blood pressure control.

You may qualify if:

  • All health plan beneficiaries 18 years-of-age and older
  • Have filled at least one blood pressure medication in the last three months,
  • Have a known hypertension diagnosis or have an uncontrolled blood pressure

You may not qualify if:

  • Not an adult
  • Not a health plan beneficiary of the self-insured employer
  • Not ambulatory and able to work or participate in care visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woodstock Pharmaceutical & Compounding Center Inc.

Woodstock, Georgia, 30188, United States

Location

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Benjamin M Bluml, RPh

    APhA Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 19, 2020

Study Start

February 6, 2020

Primary Completion

July 31, 2020

Study Completion

December 31, 2020

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations