Programme to Optimise Risk Factors in Patients Waiting for Coronary Artery Bypass Surgery
Fit For Surgery Study: A Randomised Controlled Trial of a Nurse-Led Programme to Optimise Mental and Physical Fitness for Surgery and Coronary Risk Factor Control in Patients Waiting for Coronary Artery Bypass Surgery
4 other identifiers
interventional
200
1 country
1
Brief Summary
The time spent waiting for heart surgery can be extremely stressful. This programme aims to address this by providing a home-based, nurse-led support and education programme. Patients will be followed up in their own homes monthly by a cardiac nurse and given lifestyle advice and information to prepare them for surgery. This will be evaluated to test whether providing this support improves patients' anxiety and quality of life while they wait and also whether their blood pressure, weight and cholesterol are reduced and they have a smoother recovery as a consequence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 coronary-artery-disease
Started Jan 2003
Typical duration for phase_2 coronary-artery-disease
1 active site
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
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 25, 2005
CompletedFirst Posted
Study publicly available on registry
July 27, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedAugust 5, 2005
July 1, 2005
July 25, 2005
August 4, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Anxiety
Length of hospital stay
Changes to blood pressure, smoking rate, serum cholesterol, body mass index and blood glucose from baseline
Secondary Outcomes (3)
Quality of life
Post-operative complications (cerebrovascular accident [CVA], myocardial infarction [MI], infection (wound & chest), arrhythmia requiring either formal resuscitation, pharmacological intervention or pacing)
Patients' perspective of the impact of the programme on their support and information needs (qualitative interview)
Interventions
Eligibility Criteria
You may qualify if:
- Patients waiting for first time cardiac bypass surgery
- Able to read and understand English
You may not qualify if:
- Patients living outside designated geographical area (\>1.5 hours drive from hospitals)
- Patients having surgery other than first time coronary artery bypass grafts
- Patients unable to read and understand English
- Patients with life-threatening significant non-cardiovascular disease e.g. cancer
- All risk factors under control (blood pressure \<140 systolic and/or \< 90 diastolic and/or serum cholesterol \<5 mmol/L and/or blood glucose \< 7mmol/L and anxiety score \< 8 on the Hospital Anxiety and Depression Scale).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton and Harefield NHS Trust
London, London, SW3 6NP, United Kingdom
Related Publications (1)
Goodman H, Peters E, Matthews R, Geraghty A, Godden J, Shuldham C. A pilot study using a newly devised manual in a programme of education and support for patients waiting for coronary artery bypass surgery. Eur J Cardiovasc Nurs. 2003 Apr;2(1):27-37. doi: 10.1016/S1474-5151(02)00044-0.
PMID: 14622646BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Pepper, FRCS MChir
Royal Brompton and Harefield Hospitals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2005
First Posted
July 27, 2005
Study Start
January 1, 2003
Study Completion
October 1, 2005
Last Updated
August 5, 2005
Record last verified: 2005-07