LAMP: The development and evaluation of a Lay-facilitated Angina Management Programme
| ISRCTN | ISRCTN03137160 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03137160 |
| Secondary identifying numbers | BHF No. PG/05/048 |
- Submission date
- 30/06/2005
- Registration date
- 23/08/2005
- Last edited
- 05/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
University of York
Department of Health Science
Area 2
Seebohm Rowntree Building
York
YO10 5DD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | LAMP: The development and evaluation of a Lay-facilitated Angina Management Programme |
| Study acronym | LAMP |
| Study objectives | 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(s) | North Manchester LREC, Ref: 05/Q1406/66 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2005 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key 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). |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
YO10 5DD
United Kingdom
Sponsor information
University/education
Department of Health Science
Area 3
Seebohm Rowntree Building
York
YO10 5DD
England
United Kingdom
"ROR" |
https://ror.org/04m01e293 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2012 | Yes | No |
Editorial Notes
05/02/2016: Plain English summary added.
