HypertensionNCT01101737
Trial of a Nurse Led Hypertension Clinic in Inner City General Practices
A study testing Nurse-led blood pressure clinic in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Nurse-led blood pressure clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Apr 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with last recorded blood pressure greater or equal to the British Hypertension Society audit standard
Who cannot join
- Secondary hypertension
- Housebound
- Non-English speaking
- Another major illness likely to dominate pattern of care e.g. advanced cancer, dementia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's, University of London
London, SW17 ORE
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Nurse-led blood pressure clinic
- Keywords
- Hypertension, clinical trial, nurse-led clinic, primary care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led blood pressure clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients not invited to the nurse-led clinic will continue with usual GP care |
| Nurse-led blood pressure clinic | Experimental | Patients randomly allocated to the intervention will be invited to a specialist nurse-led blood pressure clinic. Receives: Other: Nurse-led blood pressure clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
This will be assessed using two audits of practice records where blood pressure was measured and recorded independently by practice staff
Measured: 6 months
Secondary outcomes (1)
Proportion of patients in each group with final blood pressure below the British Hypertension Society optimal target
Measured: 6 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Investigators
- Sally Dean, SRN, Principal investigator, St George's, University of LondonPippa Oakeshott, MD, Study director, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101737
- Sponsor's protocol ID
- General Nursing Council 2007
- Status last verified
- Apr 2010
- First submitted
- 9 Apr 2010
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dean SC, Kerry SM, Khong TK, Kerry SR, Oakeshott P. Evaluation of a specialist nurse-led hypertension clinic with consultant backup in two inner city general practices: randomized controlled trial. Fam Pract. 2014 Apr;31(2):172-9. doi: 10.1093/fampra/cmt074. Epub 2013 Dec 19.
PubMed 24356073
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nurse-led Hypertension Clinic in Two Inner City General Practices: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01101737
- Acronym / sponsor ID
- General Nursing Council 2007
- Conditions
- Hypertension
- Keywords
- Hypertension, clinical trial, nurse-led clinic, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Apr 2010 (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 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients not invited to the nurse-led clinic will continue with usual GP care |
| Nurse-led blood pressure clinic | Experimental | Other: Nurse-led blood pressure clinicPatients randomly allocated to the intervention will be invited to a specialist nurse-led blood pressure clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with last recorded blood pressure greater or equal to the British Hypertension Society audit standard
Key exclusion criteria (4 listed)
- Secondary hypertension
- Housebound
- Non-English speaking
- Another major illness likely to dominate pattern of care e.g. advanced cancer, dementia
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 |
|---|---|---|
| Nurse-led blood pressure clinicBlood 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. | Other | Nurse-led blood pressure clinic |
Primary outcome
Change in systolic blood pressure
Time frame: 6 months
This will be assessed using two audits of practice records where blood pressure was measured and recorded independently by practice staff
1 secondary outcome
Proportion of patients in each group with final blood pressure below the British Hypertension Society optimal target
Time frame: 6 months after recruitment
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 12 Apr 2010.
- Derived from this study: PubMed 24356073Dean SC, Kerry SM, Khong TK, Kerry SR, Oakeshott P. Evaluation of a specialist nurse-led hypertension clinic with consultant backup in two inner city general practices: randomized controlled trial. Fam Pract. 2014 Apr;31(2):172-9. doi: 10.1093/fampra/cmt074. Epub 2013 Dec 19.
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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.
Sally Dean, SRN principal investigator
St George's, University of London
Pippa Oakeshott, MD study director
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led blood pressure clinic in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
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 1 inclusion and 4 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 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
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?
Change in systolic blood pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01101737, which also lists 1 linked publication.
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 12 Apr 2010.