HypertensionPhase 1NCT00662753
A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure
A Phase 1 study testing Home monitoring and monitor & phone call in people with Hypertension, run by George Washington University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Home monitoring and monitor & phone call
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Brentwood Unity Health Care Center
Washington D.C., District of Columbia, 20018
Congress Heights Unity Health Care Center
Washington D.C., District of Columbia, 20032
About this study
Official title: A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Home monitoring, monitor & phone call
- Keywords
- hypertension, home blood pressure monitoring, nurse telephone follow up, medically underserved populations
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home monitoringDevice
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 callOther
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
| Study group | Role | What they receive |
|---|---|---|
| home monitoring | Active comparator | home blood pressure monitor Receives: Device: Home monitoring |
| monitor & phone call | Experimental | home blood pressure monitor + phone calls Receives: Other: monitor & phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured: at 6 mo and 12 mo after randomization
Secondary outcomes (8)
Blood pressure measured at home
Measured: 6 and 12 months post randomization
Compliance with use of home blood pressure monitor
Measured: 6 and 12 months post randomization
Number and type of antihypertensives prescribed
Measured: 12 months post randomization
Patient satisfaction and Quality of Life
Measured: 6 and 12 months post randomization
Primary care provider satisfaction with intervention
Measured: 6 mo post randomization of a provider's first patient to enroll in the trial
Number of primary care provider visits
Measured: 12 months post randomization
Number and quality of adverse events
Measured: 3, 6, and 12 months post randomization
cost analysis
Measured: 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Patel, MD, Principal investigator, The George Washington University Medical Faculty AssociatesRichard Katz, MD, Principal investigator, The George Washington University Medical Faculty Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662753
- Sponsor's protocol ID
- SP01
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00662753
- Acronym / sponsor ID
- SP01
- Conditions
- Hypertension
- Keywords
- hypertension, home blood pressure monitoring, nurse telephone follow up, medically underserved populations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home monitoring | Active comparator | Device: Home monitoringhome blood pressure monitor |
| monitor & phone call | Experimental | Other: monitor & phone callhome blood pressure monitor + phone calls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home monitoringParticipants 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. | Device | home monitoring |
| monitor & phone callParticipants will receive all of the same interventions of the home monitoring group plus they will receive scheduled telephone follow up by the research nurse | Other | monitor & phone call |
Primary outcome
Blood Pressure
Time frame: at 6 mo and 12 mo after randomization
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Patel, MD principal investigator
The George Washington University Medical Faculty Associates
Richard Katz, MD principal investigator
The George Washington University Medical Faculty Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Home monitoring and monitor & phone call in people with Hypertension, run by George Washington University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: at 6 mo and 12 mo after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.