A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure
- Conditions
- Hypertension
- Interventions
- Device: Home monitoringOther: monitor & phone call
- Registration Number
- NCT00662753
- Lead Sponsor
- George Washington University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description home monitoring Home monitoring home blood pressure monitor monitor & phone call monitor & phone call home blood pressure monitor + phone calls
- Primary Outcome Measures
Name Time Method Blood Pressure at 6 mo and 12 mo after randomization
- Secondary Outcome Measures
Name Time Method Blood pressure measured at home 6 and 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 Number and quality of adverse events 3, 6, and 12 months post randomization cost analysis 12 months post randomization Number and type of antihypertensives prescribed 12 months post randomization Compliance with use of home blood pressure monitor 6 and 12 months post randomization Number of primary care provider visits 12 months post randomization
Trial Locations
- Locations (2)
Brentwood Unity Health Care Center
🇺🇸Washington, District of Columbia, United States
Congress Heights Unity Health Care Center
🇺🇸Washington, District of Columbia, United States