NCT01101737

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
Last Updated

April 12, 2010

Status Verified

April 1, 2010

Enrollment Period

1.8 years

First QC Date

April 9, 2010

Last Update Submit

April 9, 2010

Conditions

Keywords

Hypertension, clinical trial, nurse-led clinic, primary care

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (1)

  • Proportion of patients in each group with final blood pressure below the British Hypertension Society optimal target

    6 months after recruitment

Study Arms (2)

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.

Other: Nurse-led blood pressure clinic

Interventions

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.

Nurse-led blood pressure clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with last recorded blood pressure greater or equal to the British Hypertension Society audit standard

You may not qualify if:

  • Secondary hypertension
  • Housebound
  • Non-English speaking
  • Another major illness likely to dominate pattern of care e.g. advanced cancer, dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's, University of London

London, SW17 ORE, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Sally Dean, SRN

    St George's, University of London

    PRINCIPAL INVESTIGATOR
  • Pippa Oakeshott, MD

    St George's, University of London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 12, 2010

Study Start

February 1, 2008

Primary Completion

December 1, 2009

Study Completion

April 1, 2010

Last Updated

April 12, 2010

Record last verified: 2010-04

Locations