Evaluating the impact of a new nurse led service for people with chronic heart failure who are hospitalised, due to worsening symptoms - a randomised controlled trial
| ISRCTN | ISRCTN44159497 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44159497 |
| Secondary identifying numbers | RJ1 05/0206 |
- Submission date
- 31/10/2005
- Registration date
- 28/11/2005
- Last edited
- 19/09/2013
- 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
Ms Elaine Coady
Scientific
Scientific
Cardiology Administration
F06 East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
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 |
| Scientific title | |
| Study objectives | 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(s) | The local medical ethics committee approved on the 7th of September 2005 (ref: 05/Q0707/51) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2005 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 170 patients (85 each group) |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiology Administration
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Counting House
Guy's Hospital
St Thomas Street
London
SE19RT
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Government
Guy's & St Thomas' NHS Foundation 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 |
