A Phase 1 interventional study of Home monitoring and monitor & phone call in Hypertension, sponsored by George Washington University. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-25.
Sponsored by George Washington University · Phase 1, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 111 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
home blood pressure monitor
Device: Home monitoring
home blood pressure monitor + phone calls
Other: monitor & phone call
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.
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
Blood Pressure
Time frame: at 6 mo and 12 mo after randomization
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
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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George Washington University