Clinical trial NCT00662753: A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure
Official title: A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: hypertension
home blood pressure monitoring
nurse telephone follow up
medically underserved populations
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Blood Pressure
timeFrame: at 6 mo and 12 mo after randomization
Secondary outcomes:
measure: Blood pressure measured at home
timeFrame: 6 and 12 months post randomization
measure: Compliance with use of home blood pressure monitor
timeFrame: 6 and 12 months post randomization
measure: Number and type of antihypertensives prescribed
timeFrame: 12 months post randomization
measure: Patient satisfaction and Quality of Life
timeFrame: 6 and 12 months post randomization
measure: Primary care provider satisfaction with intervention
timeFrame: 6 mo post randomization of a provider's first patient to enroll in the trial
measure: Number of primary care provider visits
timeFrame: 12 months post randomization
measure: Number and quality of adverse events
timeFrame: 3, 6, and 12 months post randomization
measure: cost analysis
timeFrame: 12 months post randomization
Other outcomes:
Locations:
city: Washington
country: United States
facility: Brentwood Unity Health Care Center
state: District of Columbia
city: Washington
country: United States
facility: Congress Heights Unity Health Care Center
state: District of Columbia
Study officials:
affiliation: The George Washington University Medical Faculty Associates
name: Samir Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Washington University Medical Faculty Associates
name: Richard Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: