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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41781196
Enrollment
120
Registered
2013-01-16
Start date
2012-05-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease Circulatory System Cardiovascular disease, unspecified

Interventions

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 conduc

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026