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

This study has been completed.
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00124371
First received: July 25, 2005
Last updated: August 4, 2005
Last verified: July 2005
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

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)

Estimated Enrollment: 200
Study Start Date: January 2003
Estimated Study Completion Date: October 2005
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124371

Locations
United Kingdom
Royal Brompton and Harefield NHS Trust
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
British Heart Foundation
Investigators
Principal Investigator: John Pepper, FRCS MChir Royal Brompton and Harefield Hospitals
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00124371     History of Changes
Other Study ID Numbers: 2001HS030B, DHSAEPC2675, 01-180, PG02/116/14483
Study First Received: July 25, 2005
Last Updated: August 4, 2005
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
coronary artery bypass surgery
risk factors
nurse-led secondary prevention
prehabilitation
waiting period

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014