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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
Published on: April 19, 2019
Coronary risk reduction intervention for siblings and offspring of patients with premature coronary heart disease:
Justin Lee Mifsud1,2, John Stephenson3, Felicity Astin3,4
1Faculty of Health Sciences, University of Malta, Msida, Malta. justin-lee.mifsud@um.edu.mt.
Insights
This pilot study tested a new intervention for relatives of heart disease patients in Malta. The program showed potential for improving cardio-protective lifestyles in high-risk individuals.
Area of Science:
- Preventive Cardiology
- Cardiovascular Disease Risk Reduction
- Health Behavior Interventions
Background:
- Preventive cardiology programs often show limited success in promoting healthy practices among high-risk individuals.
- First-degree relatives of patients with premature coronary heart disease (CHD) are at increased risk of atherosclerotic cardiovascular disease (ASCVD).
- Malta currently lacks specific programs to support this high-risk population.
Purpose of the Study:
- To determine the feasibility and acceptability of a novel preventative intervention for first-degree relatives of patients with premature CHD.
- To assess the potential effectiveness of the intervention in reducing modifiable cardiovascular risk factors.
- To inform the design of a definitive trial for this population.
Main Methods:
- A 12-month, single-centre, two-armed group randomized controlled trial (RCT) involving 100 asymptomatic first-degree relatives.
- Intervention group received risk communication, motivational interviewing, and telephone goal reinforcement.
- Control group received only verbal lifestyle advice; feasibility assessed by recruitment/retention; qualitative interviews conducted.
Main Results:
- The study assessed changes in risk factors at baseline, 6, and 12 months.
- Qualitative interviews explored participant experiences and intervention acceptability.
- Descriptive statistics were used to assess associations between variables.
Conclusions:
- The intervention is hypothesized to lead to greater cardio-protective lifestyle improvements compared to standard advice.
- This is the first trial of its kind among Maltese first-degree relatives, addressing a critical research gap.
- Results will guide a future definitive trial on preventing cardiovascular disease in this at-risk group.
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 a preventative intervention.
Methods/Design:
We are conducting a 12-month single-centre, two-armed group randomised controlled trial (RCT), recruiting a sample of 100 asymptomatic first-degree relatives of patients with premature coronary heart disease (CHD). The study seeks to test an 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, and 12 weekly telephone goal reinforcement calls (3 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 pre-intervention and 6 and 12 months. Associations between variables will also be assessed descriptively.
Discussion:
Preventive cardiology guidelines highlighted the importance of lifestyle interventions, and lifestyle intervention adherence was proven to reduce atherosclerotic cardiovascular disease (ASCVD) risk, regardless of the individual's genetic risk. Preventive cardiology programmes may fail to adequately support persons in modifying risky behaviours, and research demonstrates that healthy practices among high-risk individuals can remain suboptimal. Siblings and offspring of patients with premature CHD are at increased risk of ASCVD. 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. The funding institution is the University of Malta.
Trial Registration:
ISRCTN, ISRCTN21559170 ; Registered 06/08/2020.
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