A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting

NCT03986931 | Completed Results DMC

• 2 other identifiers: BP Texting and PharmacistR61HL144880
• Study Type: interventional
• Target: 535
• Locations: 1 country
• Sites: 1

Brief Summary

Bidirectional texting is an effective way to collect home blood pressure (BP) measurements from subjects, but collecting BP measurements and sending them to physicians does not necessarily lead to decreased BP. Pharmacist interventions have been successful in decreasing subject BP. However, pharmacists are expensive, and in successful interventions, spent a substantial amount of time collecting home BP measurements. In this study, a proven pharmacist intervention will be added to a bidirectional texting program to determine if a combined pharmacist-bidirectional texting intervention is successful at decreasing subject BP and increasing subject BP treatment intensification in a cost-effective manner. This study will be a cluster-randomized, controlled trial of a new intervention.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Difference in Change in Systolic Blood Pressure- 12 Months

  The difference between the groups in the change from baseline to 12 months in systolic blood pressure in mm Hg.

  12 months

Secondary Outcomes (3)

• Difference in Change in Diastolic Blood Pressure- 12 Months

  12 months

• Number of Medication Changes From 6 to 12 Months

  12 months

• Dollars Spent Per Patient for 12 Month Bidirectional Texting/Pharmacist Intervention

  12 months

Study Arms (2)

Pharmacist-Bidirectional Texting Group

EXPERIMENTAL

Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.

Other: Experimental: Pharmacist-Bidirectional Texting Group

Control Group

ACTIVE COMPARATOR

Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.

Other: Active Comparator: Control Group

Interventions

Experimental: Pharmacist-Bidirectional Texting Group OTHER

The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.

Pharmacist-Bidirectional Texting Group

Active Comparator: Control Group OTHER

This group will receive bidirectional texting, but no pharmacist monitoring.

Control Group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English or Spanish
• Have a clinic measured blood pressure of \> or = 145 mmHg and/or \> or = 95 mmHg at two previous clinic visits or one previous clinic visit and on the day of enrollment
• Must be a patient at Family Medicine, River Crossings, Scott Blvd, or Muscatine University of Iowa Clinics
• Live in a zip code that is scored as a 4-10 on the Rural-Urban Commuting Area codes

You may not qualify if:

• Currently pregnant or planning to become pregnant in the next year
• Upper arm circumference greater than 50 cm (20 in)
• Prisoner status
• Unable to provide own informed consent

Sponsors & Collaborators

• Linnea Polgreen: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

  PMID: 33769555 DERIVED

• Polgreen LA, Carter BL, Polgreen PM, Snyder PM, Sewell DK, Bayman EO, Francis SL, Simmering JE, Parker C, Finkelstein R. A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP. Contemp Clin Trials. 2020 Nov;98:106169. doi: 10.1016/j.cct.2020.106169. Epub 2020 Oct 7.

  PMID: 33038500 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Linnea Polgreen
• Organization: University of Iowa

linnea-polgreen@uiowa.edu

(319) 384-3024

Study Officials

• Linnea A Polgreen, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Research interns conducting baseline and exit data collection will be blinded so that they do not influence responses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Pharmacy Practice and Science / Division of Health Services Research

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 14, 2019
• Study Start: February 25, 2020
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)