Condition category
Circulatory System
Date applied
31/10/2005
Date assigned
28/11/2005
Last edited
19/09/2013
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

Ms Elaine Coady

ORCID ID

Contact details

Cardiology Administration
F06 East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RJ1 05/0206

Study information

Scientific title

Acronym

Study hypothesis

Does a nurse led service improve outcomes for people with chronic heart failure? The principal objective is to reduce overall bed days by recurrent hospitalisations which is a common feature of this complex chronic disease. It is anticipated that by introducing a new nurse led service that will educate, monitor and advise patients and their family/carers, clinical deterioration will be noted early and acted upon. The intervention will promote the role of the patient in the monitoring and management of this long term chronic disease.

Ethics approval

The local medical ethics committee approved on the 7th of September 2005 (ref: 05/Q0707/51)

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

Condition

Chronic Heart Failure

Intervention

Nurse intervention will include two visits from the Heart Failure Specialist Nurse or Nurse Consultant during the patients in-patient stay, telephone contact will be made within one week of discharge and the patient will be seen in the nurse-led clinic within 2 weeks of discharge, subsequent nurse-led clinic visits will then continue after this period. The nurse led intervention will include support and education about the disease and treatments and guidance on how to manage at home. This group of patients will be provided with a hand-held record which contains information such as medication list, test results, weight chart etc.

Control: standard care delivery

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of episodes of readmission with main diagnosis of heart failure and bed days utilized over a 12 month period.

Secondary outcome measures

1. Use of appropriate medication
2. Self care management strategies
3. Quality of life
4. Patient illness perceptions

Overall trial start date

01/11/2005

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Main diagnosis of Heart Failure as demonstrated on echocardiogram - using the European Society of Cardiology guidelines and National Institute for Clinical Excellence (NICE) guidelines.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

170 patients (85 each group)

Participant exclusion criteria

1. Patients already exposed to a nurse led heart failure clinic
2. Patients unable to visit the clinic
3. Patients with dementia or other psychiatric disorder
4. Patients with a short anticipated survival (e.g. malignancy)

Recruitment start date

01/11/2005

Recruitment end date

01/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiology Administration
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust (UK)

Sponsor details

Counting House
Guy's Hospital
St Thomas Street
London
SE19RT
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Guy's & St Thomas' NHS Foundation 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