Condition category
Circulatory System
Date applied
06/12/2012
Date assigned
16/01/2013
Last edited
15/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiovascular 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. The target number of participants for recruitment is 120 patients.

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?
This is a feasibility study running at a single centre in Leeds.

When is the study starting and how long is it expected to run for?
The study started in May 2012 and will take 18 months to complete. We will be recruiting patients for approximately 5 months and following them up for 6 months.

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate Hill

ORCID ID

Contact details

University of Leeds
Leeds Institute of Health Sciences
Charles Thackrah Building
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom
+44 (0)113 343 0864
k.m.hill@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12/YH/0086/Version3

Study information

Scientific title

A randomised feasibility trial of systematic lifestyle referral assessment compared to standard assessment in an acute cardiology service

Acronym

HHT

Study hypothesis

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

NRES Committee - Yorkshire and Humber - Leeds East Research Ethics Committee, 12 March 2012, ref: 12/YH/0086

Study design

Randomised open feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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)

Overall trial start date

01/05/2012

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/05/2012

Recruitment end date

30/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9LJ
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

c/o Claire Skinner
Faculty of Medicine and Health
Worsley Building
Leeds
LS2 9LN
United Kingdom
+44 (0)113 343 4897
C.E.Skinner@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) as part of the Leeds, York, Bradford Collaboration for Leadership in Applied Health Research and Care (CLAHRC) (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

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23845057

Publication citations

  1. Protocol

    Hill KM, Walwyn RE, Camidge DC, Meads DM, Murray JY, Reynolds G, Farrin AJ, House AO, Lifestyle referral assessment in an acute cardiology setting: study protocol for a randomized controlled feasibility trial., Trials, 2013, 14, 212, doi: 10.1186/1745-6215-14-212.

Additional files

Editorial Notes