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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662753
First Posted: April 21, 2008
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George Washington University
  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 monitoring Other: monitor & phone call Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: at 6 mo and 12 mo after randomization ]

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

Enrollment: 111
Study Start Date: April 2008
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: home monitoring
home blood pressure monitor
Device: 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.
Experimental: monitor & phone call
home blood pressure monitor + phone calls
Other: 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00662753     History of Changes
Other Study ID Numbers: SP01
First Submitted: April 15, 2008
First Posted: April 21, 2008
Last Update Posted: February 25, 2016
Last Verified: April 2008

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