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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
a nurse led home-based education and support programme
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery bypass surgery, risk factors, nurse-led secondary prevention, prehabilitation, waiting period

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Royal Brompton and Harefield NHS Trust

Outcomes

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)

Full Information

First Posted
July 25, 2005
Last Updated
August 4, 2005
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00124371
Brief Title
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

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
British Heart Foundation

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery bypass surgery, risk factors, nurse-led secondary prevention, prehabilitation, waiting period

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
a nurse led home-based education and support programme
Primary Outcome Measure Information:
Title
Anxiety
Title
Length of hospital stay
Title
Changes to blood pressure, smoking rate, serum cholesterol, body mass index and blood glucose from baseline
Secondary Outcome Measure Information:
Title
Quality of life
Title
Post-operative complications (cerebrovascular accident [CVA], myocardial infarction [MI], infection (wound & chest), arrhythmia requiring either formal resuscitation, pharmacological intervention or pacing)
Title
Patients' perspective of the impact of the programme on their support and information needs (qualitative interview)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Pepper, FRCS MChir
Organizational Affiliation
Royal Brompton and Harefield Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton and Harefield NHS Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
14622646
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.
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Programme to Optimise Risk Factors in Patients Waiting for Coronary Artery Bypass Surgery

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