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OpenTrials
Completed

NCT Number: NCT00662753

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brentwood Unity Health Care Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Monitoring

Device

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.

monitor & phone call

Other

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

Primary outcomes

  1. Blood Pressure

    Time frame: at 6 mo and 12 mo after randomization

Secondary outcomes

  1. Blood pressure measured at home

    Time frame: 6 and 12 months post randomization

  2. Compliance with use of home blood pressure monitor

    Time frame: 6 and 12 months post randomization

  3. Number and type of antihypertensives prescribed

    Time frame: 12 months post randomization

  4. Patient satisfaction and Quality of Life

    Time frame: 6 and 12 months post randomization

  5. Primary care provider satisfaction with intervention

    Time frame: 6 mo post randomization of a provider's first patient to enroll in the trial

  6. Number of primary care provider visits

    Time frame: 12 months post randomization

  7. Number and quality of adverse events

    Time frame: 3, 6, and 12 months post randomization

  8. cost analysis

    Time frame: 12 months post randomization

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2008
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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