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

George Washington University (GW) logo

George Washington University (GW)

Status and phase

Completed
Phase 1

Conditions

Hypertension

Treatments

Device: Home monitoring
Other: monitor & phone call

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

111 participants in 2 patient groups

home monitoring
Active Comparator group
Description:
home blood pressure monitor
Treatment:
Device: Home monitoring
monitor & phone call
Experimental group
Description:
home blood pressure monitor + phone calls
Treatment:
Other: monitor & phone call

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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