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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: Home monitoring
* Other: monitor & phone call


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: home monitoring<br>home blood pressure monitor | Device: Home monitoring<br>* 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.<br>|
| Experimental: monitor & phone call<br>home blood pressure monitor + phone calls | Other: monitor & phone call<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | at 6 mo and 12 mo after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure measured at home |  | 6 and 12 months post randomization | 
| Compliance with use of home blood pressure monitor |  | 6 and 12 months post randomization | 
| Number and type of antihypertensives prescribed |  | 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 of primary care provider visits |  | 12 months post randomization | 
| Number and quality of adverse events |  | 3, 6, and 12 months post randomization | 
| cost analysis |  | 12 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, home blood pressure monitoring, nurse telephone follow up, medically underserved populations