A study to find out the best way to help people to change their lifestyle after a hospital admission

ISRCTN	ISRCTN41781196
DOI	https://doi.org/10.1186/ISRCTN41781196
Protocol serial number	12/YH/0086/Version3
Sponsor	University of Leeds (UK)
Funder	National Institute of Health Research (NIHR) as part of the Leeds, York, Bradford Collaboration for Leadership in Applied Health Research and Care (CLAHRC) (UK)

Submission date: 06/12/2012
Registration date: 16/01/2013
Last edited: 01/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Cardiovascular (heart) disease is a major health problem in the UK and a leading cause of death. However, cardiac or vascular events can be prevented by appropriate medication and lifestyle modification to reduce risk factors like high blood pressure (hypertension), high cholesterol and low levels of physical activity. There is no standardised approach to giving lifestyle advice. We think that the way that it is tackled with people can affect the uptake of referrals and subsequent behaviour change. The aim of this study is to test whether a lifestyle assessment tailored to the individual increases uptake of lifestyle interventions when compared to usual practice.

Who can participate?
People who are between the ages of 40 and 74, and admitted to a cardiology ward with a heart attack or symptoms of a suspected cardiac event, and who have risk factors for cardiovascular disease that can be modified, can take part in the study.

What does the study involve?
Participants will be asked to complete several questionnaires relating to health and behaviour. They will be randomly allocated to one of two groups to decide which lifestyle assessment will be conducted. One group will receive the usual lifestyle assessment and the other group will receive a new lifestyle assessment. Both groups will receive the same medical care and advice normally given to patients who are admitted on to a cardiology ward. Participants will be followed up twice at three and six months after the first (baseline) interview.

What are the possible benefits and risks of participating?
Some participants may find it beneficial to talk about their experiences of lifestyle change such as smoking cessation, weight loss and increased physical activity. This research will help the Leeds Teaching Hospitals Trust to improve their services which could be of benefit for patients in the future.
There are no adverse effects from participating in this type of study.

Where is the study run from?
University of Leeds (UK).

When is the study starting and how long is it expected to run for?
May 2012 to September 2013.

Who is funding the study?
The research is being funded by the National Institute of Health Research (NIHR) as part of the Leeds, York, Bradford CLAHRC (Collaboration for Leadership in Applied Health Research and Care).

Who is the main contact?
Dr Kate Hill
k.m.hill@leeds.ac.uk

Contact information

Dr Kate Hill
Scientific

University of Leeds
Leeds Institute of Health Sciences
Charles Thackrah Building
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom

Phone	+44 (0)113 343 0864
Email	k.m.hill@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised open feasibility trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised feasibility trial of systematic lifestyle referral assessment compared to standard assessment in an acute cardiology service
Study acronym	HHT
Study objectives	Current local practice for patients admitted to hospital with a possible cardiac event is to ask routine questions about lifestyle and behaviours like smoking, alcohol consumption and diet. However, coverage using these questions is patchy, and there is no consistent approach to onward referrals in response to the needs identified. Our hypothesis is that using a systematic assessment that identifies individual barriers and tailors advice and referrals will improve uptake of lifestyle interventions and subsequent behaviour change.
Ethics approval(s)	NRES Committee - Yorkshire and Humber - Leeds East Research Ethics Committee, 12/03/2012, ref: 12/YH/0086
Health condition(s) or problem(s) studied	Cardiovascular disease
Intervention	Participants will be asked to complete several questionnaires relating to health and behaviour. They will be randomly allocated to one of two groups to decide which lifestyle assessment will be conducted. One group will receive the usual lifestyle assessment and the other group will receive a new lifestyle assessment. Both groups will receive the same medical care and advice normally given to patients who are admitted on to a cardiology ward. Participants will be followed up twice at three and six months after the first (baseline) interview.
Intervention type	Behavioural
Primary outcome measure(s)	1. Modification of lifestyle behaviour or quality of life 2. Successful uptake, with two distinct components: 2.1. Accept referral or self referral to a formal lifestyle programme (yes/no) 2.2. Participate in a lifestyle change intervention or a self-directed programme of lifestyle modification (no participation; participation initiated; participation initiated/persisted; participation initiated/persisted/ maintained) 3. Participation will be evaluated by self-reported attendance or, for those who undertake self-directed lifestyle change, from self reported activities using structured qualitative methods. While the categories will be the same for acceptance and participation across arms and options, the criteria/derivation differs. Where data is taken from a qualitative interview, rather than a structured proforma, two raters will independently classify participants. Where there are discrepancies, these will be discussed and a consensus reached.
Key secondary outcome measure(s)	1. Safety (i.e. death) 2. Acceptability of assessment tool (qualitative only) 3. Patient's experiences of making lifestyle changes (qualitative only) 4. Eligibility, refusal, recruitment and follow-up rates 5. Preferred/actual method of follow-up 6. Proportion of missing items, scales and visits 7. Change in lifestyle (i.e. change in smoking, alcohol consumption, diet and physical activity) 8. Social Satisfaction (SSQ) 9. Clinical Outcomes in Routine Evaluation (CORE-10) 10. European Quality of Life - 5 Dimensions (EQ-5D)
Completion date	30/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Admitted to hospital with a diagnosis of acute coronary event or myocardial infarction or symptoms of a cardiac nature 2. Male and females aged between 40 and 74 years of age 3. Willing to give written informed consent
Key exclusion criteria	1. Aged less than 40 or over 74 years of age at the time of screening 2. Currently receiving specialist treatment with a primary focus on alcohol, smoking, diet or exercise 3. No risk factors for vascular events 4. No-fixed abode (i.e. not available for follow-up) 5. Currently serving a sentence in prison or outstanding legal issues likely to lead to imprisonment (i.e. not available for follow-up) 6. Unwilling to give written informed consent 7. Unable to give written informed consent 8. Unable to take part in either intervention using spoken English 9. Unable to self-complete the English language outcome measure tools
Date of first enrolment	01/05/2012
Date of final enrolment	30/09/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Leeds

Leeds
LS2 9LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/11/2015		Yes	No
Protocol article	protocol	11/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes