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

NCT00662753 | Completed Phase 1

• 1 other identifier: SP01
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Keywords

hypertension; home blood pressure monitoring; nurse telephone follow up; medically underserved populations

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  at 6 mo and 12 mo after randomization

Secondary Outcomes (8)

• Blood pressure measured at home

  6 and 12 months post randomization

• Compliance with use of home blood pressure monitor

  6 and 12 months post randomization

• Number and type of antihypertensives prescribed

  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

Study Arms (2)

home monitoring

ACTIVE COMPARATOR

home blood pressure monitor

Device: Home monitoring

monitor & phone call

EXPERIMENTAL

home blood pressure monitor + phone calls

Other: monitor & phone call

Interventions

Home monitoring 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.

home monitoring

monitor & phone call 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

monitor & phone call

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (2)

Brentwood Unity Health Care Center

Washington D.C., District of Columbia, 20018, United States

Location

Congress Heights Unity Health Care Center

Washington D.C., District of Columbia, 20032, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Samir Patel, MD

  The George Washington University Medical Faculty Associates

  PRINCIPAL INVESTIGATOR

• Richard Katz, MD

  The George Washington University Medical Faculty Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2008-04

Locations

US (2)