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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124371
• Other study ID #: 2001HS030B
• Secondary ID: DHSAEPC267501-18
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 25, 2005
• Last updated: August 4, 2005
• Start date: January 2003
• Est. completion date: October 2005

Study information

• Verified date: July 2005
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• a nurse led home-based education and support programme

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety
Primary	Length of hospital stay
Primary	Changes to blood pressure, smoking rate, serum cholesterol, body mass index and blood glucose from baseline
Secondary	Quality of life
Secondary	Post-operative complications (cerebrovascular accident [CVA], myocardial infarction [MI], infection (wound & chest), arrhythmia requiring either formal resuscitation, pharmacological intervention or pacing)
Secondary	Patients’ perspective of the impact of the programme on their support and information needs (qualitative interview)