A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure

NCT ID: NCT00662753

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2015-06-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

home monitoring

home blood pressure monitor

Group Type: ACTIVE_COMPARATOR

Home monitoring

Intervention Type: DEVICE

Participants will receive a home blood pressure monitor and be taught how to use it. They will have an education session to review treatment goals, medications, diet and exercise. They will be asked to see their primary care provider at least every 3 months and the research nurse at 3, 6 and 12 months.

monitor & phone call

home blood pressure monitor + phone calls

Group Type: EXPERIMENTAL

monitor & phone call

Intervention Type: OTHER

Participants will receive all of the same interventions of the home monitoring group plus they will receive scheduled telephone follow up by the research nurse

Interventions

Home monitoring

Participants will receive a home blood pressure monitor and be taught how to use it. They will have an education session to review treatment goals, medications, diet and exercise. They will be asked to see their primary care provider at least every 3 months and the research nurse at 3, 6 and 12 months.

Intervention Type: DEVICE

monitor & phone call

Participants will receive all of the same interventions of the home monitoring group plus they will receive scheduled telephone follow up by the research nurse

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samir Patel, MD

Role: PRINCIPAL_INVESTIGATOR

The George Washington University Medical Faculty Associates

Richard Katz, MD

Role: PRINCIPAL_INVESTIGATOR

The George Washington University Medical Faculty Associates

Locations

Brentwood Unity Health Care Center

Washington D.C., District of Columbia, United States

Congress Heights Unity Health Care Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

SP01

Identifier Type: -

Identifier Source: org_study_id