Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
20/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Mant

ORCID ID

Contact details

Institute of Health Sciences
University of Oxford
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 226 770
david.mant@dphpc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MC10

Study information

Scientific title

Acronym

Study hypothesis

Patients with established coronary heart disease have a lower mortality rate and less morbidity if they make changes in their behaviour (smoking, diet, exercise, weight), and are given appropriate medication (aspirin, beta blockers, lipid lowering drugs etc).
Achieving these interventions involves collaboration between patients and families, hospital staff, and primary care teams which is often not done well.
The main aim of this study was to see if the use of specialist liaison nurses to co-ordinate care at hospital discharge and to support existing rehabilitation and primary care services was cost-effective in reducing morbidity and cardiovascular risk in the year after myocardial infarction.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Heart disease

Intervention

1. Use of liaison nurses - sought to co-ordinate care, support the patient and family, support the practice nurses, and support the cardiac rehabilitation programme.
The liaison nurses were not involved with management of individual patients but sought to encourage the use of current models of behaviour change, achieve a structured programme for each patient, and promote the use of effective treatments.
2. No use of liaison nurses, i.e. standard care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. At assessment demographic data and information on smoking and diet were collected. The patient's weight, height, blood pressure, and blood cholesterol were measured.
2. The three questionnaires asked about smoking, exercise, and diet; drug treatment; attendance at rehabilitation and other health services; and symptoms of pain and breathlessness.
3. Psychological state was assessed using the Hospital Anxiety and Depression scale
4. Quality of life using the Euroqual scale
5. At 12 months the clinical examination repeated the baseline measurements, together with a measurement of blood cotinine in those who had ever smoked, and a 6 minute exercise test.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

01/07/1997

Reason abandoned

Eligibility

Participant inclusion criteria

597 patients from 67 practices in Southampton and South-West Hampshire who had been admitted to hospital or attended a chest pain clinic with a myocardial infarct or recent-onset angina were recruited to the study. 38 patients died within 12 months.
Follow up rates were about 90%.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

597

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/1995

Recruitment end date

01/07/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health Sciences
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1998 results in http://www.ncbi.nlm.nih.gov/pubmed/10078796
2. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10074017

Publication citations

  1. Results

    Jolly K, Bradley F, Sharp S, Smith H, Mant D, Follow-up care in general practice of patients with myocardial infarction or angina pectoris: initial results of the SHIP trial. Southampton Heart Integrated Care Project., Fam Pract, 1998, 15, 6, 548-555.

  2. Results

    Jolly K, Bradley F, Sharp S, Smith H, Thompson S, Kinmonth AL, Mant D, Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP). The SHIP Collaborative Group., BMJ, 1999, 318, 7185, 706-711.

Additional files

Editorial Notes