A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial

George Washington University2 sites in 1 country111 target enrollmentApril 2008

ConditionsHypertension

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypertension
Sponsor: George Washington University
Enrollment: 111
Locations: 2
Primary Endpoint: Blood Pressure
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if the use of home blood pressure monitors plus nurse telephone monitoring is more effective than the use of blood pressure monitors alone in improving control of high blood pressure in an urban medical clinic.

Detailed Description

Participants will all have home blood pressure monitors, education session on controlling their blood pressure and will be randomized to recieve 6 months of intensive telephonic on a set monitoring schedule or no telephonic follow up. Phone calls will be weekly for 4 weeks, then every 2 weeks for 8 weeks then monthly for 3 months.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

George Washington University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•diagnosed with essential hypertension
•systolic blood pressure \>140 mm Hg (130 if diabetic) OR diastolic blood pressure \> 90 mm Hg (80 if diabetic)on at least 2 clinic visits prior to randomization
•BP at time of screening is \> than systolic 140 (130 if diabetic) or diastolic 90 (80 if diabetic)
•patient is prescribed at least 1 antihypertensive medication
•Patient is fluent in English
•Patient is easily accessible by telephone

Exclusion Criteria

•persons with stage 4 or 5 chronic kidney disease or end stage renal disease on dialysis
•Patients with a terminal illness
•Patients with severe dementia or serious mental illness
•Inability to preform self blood pressure monitoring
•Patient lacks a functioning home phone or personal cellular phone
•Pregnant or planning to get pregnant
•Arm circumference exceeds the allowable limit on the largest home BP monitor cuff

Outcomes

Primary Outcomes

Blood Pressure

Time Frame: at 6 mo and 12 mo after randomization

Secondary Outcomes

Blood pressure measured at home(6 and 12 months post randomization)
Patient satisfaction and Quality of Life(6 and 12 months post randomization)
Primary care provider satisfaction with intervention(6 mo post randomization of a provider's first patient to enroll in the trial)
Number and quality of adverse events(3, 6, and 12 months post randomization)
cost analysis(12 months post randomization)
Number and type of antihypertensives prescribed(12 months post randomization)
Compliance with use of home blood pressure monitor(6 and 12 months post randomization)
Number of primary care provider visits(12 months post randomization)