- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101737
Trial of a Nurse Led Hypertension Clinic in Inner City General Practices
April 9, 2010 updated by: St George's, University of London
Evaluation of a Nurse-led Hypertension Clinic in Two Inner City General Practices: Randomised Controlled Trial
The investigators will do a trial in two general practices to see if the introduction of a blood pressure clinic staffed by a specialist nurse supported by visiting consultant improves blood pressure control compared to usual care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
353
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW17 ORE
- St George's, University of London
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with last recorded blood pressure greater or equal to the British Hypertension Society audit standard
Exclusion Criteria:
- Secondary hypertension
- Housebound
- Non-English speaking
- Another major illness likely to dominate pattern of care e.g. advanced cancer, dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Usual care
Patients not invited to the nurse-led clinic will continue with usual GP care
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Experimental: Nurse-led blood pressure clinic
Patients randomly allocated to the intervention will be invited to a specialist nurse-led blood pressure clinic.
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Blood pressure will be measured according to protocol.For patients with blood pressure above optimal targets, treatment changes will be discussed with the patient, a visiting consultant physician and the patient's GP.
If they agree, the GP will intensify anti-hypertensive treatment with monthly follow up by the specialist nurse until BP targets are achieved.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in systolic blood pressure
Time Frame: 6 months
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This will be assessed using two audits of practice records where blood pressure was measured and recorded independently by practice staff
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients in each group with final blood pressure below the British Hypertension Society optimal target
Time Frame: 6 months after recruitment
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6 months after recruitment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sally Dean, SRN, St George's, University of London
- Study Director: Pippa Oakeshott, MD, St George's, University of London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
April 9, 2010
First Submitted That Met QC Criteria
April 9, 2010
First Posted (Estimate)
April 12, 2010
Study Record Updates
Last Update Posted (Estimate)
April 12, 2010
Last Update Submitted That Met QC Criteria
April 9, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- General Nursing Council 2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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