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

April 15, 2008
September 24, 2012
April 2008
December 2012   (final data collection date for primary outcome measure)
Blood Pressure [ Time Frame: at 6 mo and 12 mo after randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662753 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure
A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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.
  • 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
  • Active Comparator: home monitoring
    Intervention: Device: Home blood pressure monitor
  • Experimental: monitor & phone call
    Intervention: Other: monitor and phone call
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662753
SP01
No
George Washington University
George Washington University
Not Provided
Principal Investigator: Samir Patel, MD The George Washington University Medical Faculty Associates
Principal Investigator: Richard Katz, MD The George Washington University Medical Faculty Associates
George Washington University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP