Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Donnelly

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
University of Nottingham Division of Vascular Medicine
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 (0)1332 254966
richard.donnelly@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077117128

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Hypertensive medication

Primary outcome measures

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 trial start date

03/10/2002

Overall trial end date

02/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with hypertension requiring treatment and those on treatment whose blood pressure is not well controlled.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

03/10/2002

Recruitment end date

02/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/04/2016: No publications found, verifying study status with principal investigator