Condition category
Circulatory System
Date applied
30/06/2005
Date assigned
23/08/2005
Last edited
05/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Coronary heart disease (CHD), also known as ischemic heart disease, is one of the leading causes of death worldwide. CHD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood). When arteries are blocked or narrowed, the heart does not receive enough blood to function properly, which can cause pain and tightness in the chest (angina). Some forms of angina can be treated using medications, however many people need surgical treatment in order to show significant improvement. A recent study showed that educating angina patients about how to better manage their condition could help to improve symptoms and encourage changes to unhealthy lifestyle choices. This study will to look at a lay-led angina management (LAMP) programme, in which patients will be educated about their conditions and receive cognitive behavioural therapy (a type of talking therapy designed to help change ways of thinking and behaving). The aim of this study is to look at whether the LAMP programme can be used to help people to better manage their angina.

Who can participate?
Adults with angina who require surgical treatment.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group attend the clinic of an angina nurse specialist where they will receive a 15 minute appointment giving lifestyle advice, such as quitting smoking, and written information about their condition. Those in the second group take part in a 45 minute appointment with a trained lay (plain English) facilitator (people with experience of heart disease either personally or as a carer) where they are given in-depth advice and explanations about their condition. These patients are also given access to cognitive behavioural therapy (CBT) to help them change their habits, a workbook to record their progress which is discussed with the lay facilitator in follow up home visits or phone calls and a relaxation programme on CD. Participants are also referred to their local stop smoking service (if applicable). Participants in both groups are asked to keep a week-long diary recording their angina symptoms which is assessed at the start of the study and again after 6 months to see if their symptoms have improved.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Bury Primary Care NHS Trust and Fairfield Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2005 to September 2008

Who is funding the study?
British Heart Foundation (UK)

Who is the main contact?
Dr Gill Furze

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gill Furze

ORCID ID

Contact details

University of York
Department of Health Science
Area 2
Seebohm Rowntree Building
York
YO10 5DD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BHF No. PG/05/048

Study information

Scientific title

LAMP: The development and evaluation of a Lay-facilitated Angina Management Programme

Acronym

LAMP

Study hypothesis

The primary objective is to assess whether a manualised self-help cognitive behavioural therapy (CBT) rehabilitation programme for patients with angina, facilitated by lay workers, will produce a greater reduction in angina frequency than a health education session delivered in a clinic by a specialist nurse.

Ethics approval

North Manchester LREC, Ref: 05/Q1406/66

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Angina

Intervention

Participants will be randomised to receive:
1. A 15 minute follow-up appointment with adjunctive written materials and routine medical care
2. Lay-led Angina Management Programme and routine medical care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Frequency of angina as measured using a patient held angina diary (mean number of angina episodes per week).

Secondary outcome measures

Secondary outcomes will include differences between baseline and six-month follow-up on: Euroaction SCORE of cardiovascular disease (CVD) risk, scales of the Seattle Angina Questionnaire, anxiety and depression scores on the HADS, increased activity levels as measured by a weeks ambulatory monitoring and self-rated activity level, economic cost utility including service use, cost of the intervention, and the EQ-5D.

Overall trial start date

01/10/2005

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All patients receiving a diagnosis of angina following symptom-limited exercise treadmill test, thallium scintigraphy or angiography and not, in the judgement of the cardiologist, requiring urgent coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Exercise induced arrhythmias or loss of systolic BP greater than 20 mmHg during exercise stress testing
2. Self-report of rapidly increasing number and duration of attacks of angina
3. A score of 4 on the Canadian Heart Association classification of angina or the New York Heart Association (NYHA) classification of heart failure
4. Myocardial infarction still awaiting cardiac rehabilitation
5. Life-threatening co-morbidities
6. Documented psychiatric problems (other than mild to moderate uni-polar depression or a simple anxiety state)
7. Dementia or confusion

Recruitment start date

01/10/2005

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Department of Health Science
Area 3
Seebohm Rowntree Building
York
YO10 5DD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) PG/05/048 (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

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22229483

Publication citations

  1. Results

    Furze G, Cox H, Morton V, Chuang LH, Lewin RJ, Nelson P, Carty R, Norris H, Patel N, Elton P, Randomized controlled trial of a lay-facilitated angina management programme., J Adv Nurs, 2012, 68, 10, 2267-2279, doi: 10.1111/j.1365-2648.2011.05920.x.

Additional files

Editorial Notes

05/02/2016: Plain English summary added.