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

NCT ID: NCT00124371

Last Updated: 2005-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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coronary artery bypass surgery risk factors nurse-led secondary prevention prehabilitation waiting period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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a nurse led home-based education and support programme

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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John Pepper, FRCS MChir

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Harefield Hospitals

Locations

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Royal Brompton and Harefield NHS Trust

London, London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 14622646 (View on PubMed)

Other Identifiers

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DHSAEPC2675

Identifier Type: -

Identifier Source: secondary_id

01-180

Identifier Type: -

Identifier Source: secondary_id

PG02/116/14483

Identifier Type: -

Identifier Source: secondary_id

2001HS030B

Identifier Type: -

Identifier Source: org_study_id