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

Sponsor:	George Washington University
Information provided by:	George Washington University
ClinicalTrials.gov Identifier:	NCT00662753

Purpose

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.

Condition	Intervention	Phase
Hypertension	Device: Home blood pressure monitor Other: monitor and phone call	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:

Blood Pressure [ Time Frame: at 6 mo and 12 mo after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood pressure measured at home [ Time Frame: 6 and 12 months post randomization ] [ Designated as safety issue: No ]
Compliance with use of home blood pressure monitor [ Time Frame: 6 and 12 months post randomization ] [ Designated as safety issue: No ]
Number and type of antihypertensives prescribed [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
Patient satisfaction and Quality of Life [ Time Frame: 6 and 12 months post randomization ] [ Designated as safety issue: No ]
Primary care provider satisfaction with intervention [ Time Frame: 6 mo post randomization of a provider's first patient to enroll in the trial ] [ Designated as safety issue: No ]
Number of primary care provider visits [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
Number and quality of adverse events [ Time Frame: 3, 6, and 12 months post randomization ] [ Designated as safety issue: No ]
cost analysis [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: home monitoring	Device: Home blood pressure monitor 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.
Experimental: monitor & phone call	Other: monitor and 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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662753

Locations

United States, District of Columbia
Brentwood Unity Health Care Center
Washington, District of Columbia, United States, 20018
Congress Heights Unity Health Care Center
Washington, District of Columbia, United States, 20032

Sponsors and Collaborators

George Washington University

Investigators

Principal Investigator:	Samir Patel, MD	The George Washington University Medical Faculty Associates
Principal Investigator:	Richard Katz, MD	The George Washington University Medical Faculty Associates

More Information

No publications provided

Responsible Party:	Samir Patel, MD /Principle Investigator, The George Washington University Medical Faculty Associates
ClinicalTrials.gov Identifier:	NCT00662753 History of Changes
Other Study ID Numbers:	SP01, IRB # 100703
Study First Received:	April 15, 2008
Last Updated:	June 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by George Washington University:

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

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012