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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by George Washington University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT00662753
First received: April 15, 2008
Last updated: September 24, 2012
Last verified: April 2008
History of Changes
  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 1

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:

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 2012
Estimated Primary Completion Date: December 2012 (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: George Washington University
ClinicalTrials.gov Identifier: NCT00662753     History of Changes
Other Study ID Numbers: SP01
Study First Received: April 15, 2008
Last Updated: September 24, 2012
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 May 19, 2013