A pilot project to evaluate a nurse-implemented 'Group Protocol' for the management of patients requiring treatment with anti-hypertensive medication

ISRCTN	ISRCTN12248079
DOI	https://doi.org/10.1186/ISRCTN12248079
Secondary identifying numbers	N0077117128

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 21/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R Donnelly
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
University of Nottingham Division of Vascular Medicine
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Phone	+44 (0)1332 254966
Email	richard.donnelly@nottingham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A pilot project to evaluate a nurse-implemented 'Group Protocol' for the management of patients requiring treatment with anti-hypertensive medication
Study objectives	1. That the implementation of the Southern Derbyshire Acute Hospitals NHS Trust Group Protocol for the treatment of hypertension improves the proportion of patients achieving target levels of blood pressure compared to standard care 2. That the group protocol provides a safe and effective method of managing this group of patients
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Hypertension
Intervention	Patients will be randomised to 'usual' care (treatment by their general practitioner) who will be sent a treatment plan or 'Group Directions'. Patients randomised to the Group Direction will be seen at 2-4 week intervals according to the protocol contained in the Southern Derbyshire Acute Hospitals NHS Trust Group Protocol for the management of anti-hypertensive therapy by specialist nurses. After 6 months the groups will be compared.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hypertensive medication
Primary outcome measure	1. The proportion of patients achieving adequate and optimal blood pressure control 2. Treatment satisfaction 3. Safety
Secondary outcome measures	Not provided at time of registration
Overall study start date	03/10/2002
Completion date	02/10/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients with hypertension requiring treatment and those on treatment whose blood pressure is not well controlled.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	03/10/2002
Date of final enrolment	02/10/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE1 2QY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Southern Derbyshire Acute Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

21/12/2020: Internal review.
18/04/2016: No publications found, verifying study status with principal investigator