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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22229483
Publication citations
-
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.