NCT02898584

Brief Summary

The purpose of this research study is to test the feasibility, acceptability, and preliminary effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP monitoring and medication reminders with patients recruited from a primary care setting, as well as identify challenges and potential solutions to broader implementation of a mobile pharmacist-led home-based BP monitoring intervention in primary care clinics through key stakeholder interviews.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2016

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.7 years

First QC Date

September 8, 2016

Last Update Submit

July 13, 2020

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    from baseline to 12 weeks

Secondary Outcomes (1)

  • Change in medication adherence as measured by the Adherence to Refills and Medications Scale (ARMS)

    from baseline to 12 weeks

Study Arms (1)

BP Track

OTHER

The study participants will be asked to monitor their blood pressure twice daily at home for twelve weeks, and sync the data to the mobile intervention so that a clinical pharmacist can review and incorporate the data into ongoing hypertension management.

Other: BP Track

Interventions

BP TrackOTHER
BP Track

Eligibility Criteria

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

You may qualify if:

  • Have a smart phone compatible with mobile intervention
  • Have been previously diagnosed with hypertension
  • Have uncontrolled hypertension (systolic blood pressure \> 140 and/or diastolic blood pressure \> 90 on repeat measurement)
  • Be under the care of a primary care physician at the recruitment clinic
  • Be taking at least one antihypertensive medication
  • Be English speaking

You may not qualify if:

  • Patients under the care of a clinical pharmacist for hypertension management, or under the care of a cardiologist
  • Pregnant patients and anyone with the following unrelated, but serious medical conditions will also be excluded, as they may make blood pressure control difficult or necessitate frequent hospitalization: previous diagnosis of resistant hypertension; steroid dependent asthma or emphysema; cirrhosis or hepatic failure; stage C or D chronic heart failure; stage IV or V chronic kidney disease; and cancer (terminal or undergoing active chemotherapeutic or radiation therapy)
  • Patients with other serious medical conditions (e.g., stroke, dementia) that may affect their ability to self-monitor blood pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (2)

  • Buis LR, Roberson DN, Kadri R, Rockey NG, Plegue MA, Danak SU, Guetterman TC, Johnson MG, Choe HM, Richardson CR. Understanding the Feasibility, Acceptability, and Efficacy of a Clinical Pharmacist-led Mobile Approach (BPTrack) to Hypertension Management: Mixed Methods Pilot Study. J Med Internet Res. 2020 Aug 11;22(8):e19882. doi: 10.2196/19882.

    PMID: 32780026DERIVED

  • Buis LR, Roberson DN, Kadri R, Rockey NG, Plegue MA, Choe HM, Richardson CR. Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care: Study Protocol. JMIR Res Protoc. 2017 Oct 10;6(10):e193. doi: 10.2196/resprot.8059.

    PMID: 29017994DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Lorraine R Buis, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family Medicine, Medical School and Assistant Professor of Information, School of Information

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)