Programme to Optimise Risk Factors in Patients Waiting for Coronary Artery Bypass Surgery

Sponsor

Royal Brompton & Harefield NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00124371

Collaborator

British Heart Foundation (Other)

200

Enrollment

Location

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Behavioral: a nurse led home-based education and support programme	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2003

Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Anxiety []
Length of hospital stay []
Changes to blood pressure, smoking rate, serum cholesterol, body mass index and blood glucose from baseline []

Secondary Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).