Coronary risk reduction intervention for siblings and offspring of patients with premature coronary heart disease: the CRISO study protocol for a randomised controlled pilot study

Justin Lee Mifsud, John Stephenson, Felicity Astin, Joseph Galea

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Research has consistently demonstrated that preventive cardiology programs have limited success, and healthy practices among high-risk individuals remain suboptimal. Furthermore, there are no current programmes in Malta that offer support to first degree relatives of patients with premature coronary heart disease. This internal pilot study will determine the feasibility, acceptability, and potential effectiveness of preventative intervention.

Methods/design: We are conducting a 12-month single-centre, two-armed group RCT, recruiting a sample of 100 asymptomatic first-degree relatives of patients with premature coronary heart disease (CHD). The study seeks to test a drafted evidence-based intervention to reduce modifiable risk and determine its feasibility and acceptability. The Intervention will be delivered at an outpatient office based in a large acute academic hospital. It will comprise risk communication using an online risk calculator, a counselling style adapted from motivational interviewing, and12 weekly telephone goal reinforcement calls (three months). Control subjects will receive verbal lifestyle advice only. Feasibility will be assessed through recruitment and retention. Qualitative evaluation interviews will be conducted with a subsample of 24 purposefully selected participants at 12 months. Assessment for risk factor changes will be measured at pre34 intervention, six, and 12 months. Associations between variables will also be assessed.

Discussion: Preventive cardiology has highlighted the importance of lifestyle interventions, and adherence to these lifestyle interventions have been proven to reduce CVD risk, regardless of the individual's genetic risk. Siblings and offspring of patients with premature CHD are at increased risk of CHD. Despite this, there is no process in place for routine screening and support to modify risk. It is hypothesised that participants assigned to the intervention arm will show more cardio-protective lifestyle-related improvement from the baseline than those in the control group. To date, this is the first trial being conducted amongst Maltese first-degree relatives. This study addresses the needed research, and the results will inform a definitive trial.
Original languageEnglish
JournalPilot and Feasibility Studies
Publication statusAccepted/In press - 21 Jun 2021

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