Clinical trial NCT00124371: Programme to Optimise Risk Factors in Patients Waiting for Coronary Artery Bypass Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery bypass surgery
risk factors
nurse-led secondary prevention
prehabilitation
waiting period
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2005-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: While waiting for coronary artery bypass graft (CABG) surgery many patients receive little if any medical and nursing input, at a time which is very stressful for them and their families. This randomised controlled trial will test whether a home-based, nurse-led support and education programme for patients waiting for such surgery can optimise mental and physical fitness and improve coronary heart disease risk factors by addressing anxiety, hypertension, obesity, diabetes and serum cholesterol in the waiting period. 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. Primary outcome measurements will be anxiety, length of stay, blood pressure, cholesterol, blood glucose, smoking and body mass index. Secondary outcomes will be quality of life, and post-operative complications. Economic analysis and qualitative assessment of patients' opinion of the programme will also be performed.

Eligibility criteria: Inclusion Criteria:

* Patients waiting for first time cardiac bypass surgery
* Able to read and understand English

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Anxiety
measure: Length of hospital stay
measure: Changes to blood pressure, smoking rate, serum cholesterol, body mass index and blood glucose from baseline
Secondary outcomes:
measure: Quality of life
measure: Post-operative complications (cerebrovascular accident [CVA], myocardial infarction [MI], infection (wound & chest), arrhythmia requiring either formal resuscitation, pharmacological intervention or pacing)
measure: Patients' perspective of the impact of the programme on their support and information needs (qualitative interview)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Trust
Study officials:
affiliation: Royal Brompton and Harefield Hospitals
name: John Pepper, FRCS MChir
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.