Key result
A family-based cardiovascular risk reduction intervention significantly improved combined risk factor control at 2 years compared to usual care (64% vs 46%; OR 2.2; 95% CI 1.7-2.7; P<0.0001).
Why the study?
Does a family-based cardiovascular risk reduction intervention improve cardiovascular risk factor control in individuals with a family history of premature coronary heart disease?
RCT (n=1,622)
Open-label
Cluster
No
Does a family-based cardiovascular risk reduction intervention improve cardiovascular risk factor control in individuals with a family history of premature coronary heart disease?
Odds Ratio: 2.2 (95% CI 1.7–2.7)
Absolute Event Rate: 64% vs 46%
p-value: p=<0.0001
A family-based intervention utilizing proactive home visits by trained health workers significantly improves cardiovascular risk factor control in individuals with a family history of premature coronary heart disease.
The results of the PROLIFIC trial by Panniyammakal Jeemon and colleagues1Jeemon P Harikrishnan S Ganapathi S et al.Efficacy of a family-based cardiovascular risk reduction intervention in individuals with a family history of premature coronary heart disease in India (PROLIFIC): an open-label, single-centre, cluster randomised controlled trial.Lancet Glob Health. 2021; 9: e1442-e1450Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar published in The Lancet Global Health have the potential to improve the cardiovascular health of people living in low-income and middle-income countries. Jeemon and colleagues’ study is an attempt to control risk factors for cardiovascular disease at the family level, either by the patient alone or with family members. Adherence to lifestyle and compliance of drugs is essential to control risk factors. Considering the escalating burden of cardiovascular diseases in low-income and middle-income countries, the PROLIFIC trial1Jeemon P Harikrishnan S Ganapathi S et al.Efficacy of a family-based cardiovascular risk reduction intervention in individuals with a family history of premature coronary heart disease in India (PROLIFIC): an open-label, single-centre, cluster randomised controlled trial.Lancet Glob Health. 2021; 9: e1442-e1450Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar substantially contributes towards the primary and secondary prevention of coronary heart disease. The study by Jeemon and colleagues showed that 13 home visits and repeated reminders had a positive effect on adhering to therapy and controlling risk factors such as unhealthy diet, tobacco cessation, home blood pressure monitoring, blood sugar monitoring, and emphasis on daily exercise. The effectiveness of the intervention was shown by the primary outcome results: at the 2-year follow-up, the primary outcome of blood pressure lower than 140/90 mm Hg, fasting plasma glucose lower than 110 mg/dL, low-density lipoprotein cholesterol lower than 100 mg/dL, and abstinence from tobacco was achieved by 514 (64%) of 803 participants in the intervention group and 379 (46%) of 819 partcipants in the usual care group, after adjustment for clustering and baseline risk factors (odds ratio 2·2, 95% CI 1·7–2·7; p<0·0001).1Jeemon P Harikrishnan S Ganapathi S et al.Efficacy of a family-based cardiovascular risk reduction intervention in individuals with a family history of premature coronary heart disease in India (PROLIFIC): an open-label, single-centre, cluster randomised controlled trial.Lancet Glob Health. 2021; 9: e1442-e1450Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar Proactive home visits by trained health workers have the potential to improve cardiovascular health. Training of health workers for better control of risk factors at the family level can prevent the development of clinical disease. Heart disease at a young age creates an economic burden not only for the family, but also for the society and country due to the cost of health-care services, medicines, and lost productivity. The intervention cost mentioned in this trial (USD 47·4 per family, per year) is much lower than the cost spent if someone is diagnosed with a cardiovascular disease. If this low-cost intervention is incorporated into the existing community health scheme, it is more likely to be effective than is standard care. Research on family interventions for the management of coronary heart disease is in its infancy and the present study is an important step in developing more realistic and systematic trials in the future. Achieving lifestyle changes and adherence to these changes is challenging. Adherence to evidence-based pharmacotherapy and lifestyle modification for control of risk factors is associated with a reduced incidence of cardiovascular disease. As the time passes after the index event, patient adherence to lifestyle changes becomes less. To improve adherence, repetitive reminders by physical presence of a health worker or digital health-based interventions seems to be beneficial. In a multicentre trial from India, it was shown that trained community health workers could improve medicine adherence, lifestyle modifications, and clinical risk markers in Acute Coronary Syndrome Indian patients.2Xavier D Gupta R Kamath D et al.Community health worker-based intervention for adherence to drugs and lifestyle change after acute coronary syndrome: a multicentre, open, randomised controlled trial.Lancet Diabetes Endocrinol. 2016; 4: 244-253Summary Full Text Full Text PDF PubMed Scopus (76) Google Scholar However, very few studies exist in India linking behavioural outcomes to health benefits such as morbidity and mortality. The PROLIFIC trial was done in family members of patients with premature coronary heart disease. Younger patients with coronary heart disease often have a family history of premature coronary heart disease. This association between family history and coronary heart disease in young people can be environmental and indicates a possible genetic susceptibility. Familial hypercholesterolemia is one of the most common genetic disorders of lipid metabolism, which is an underdiagnosed, undertreated cause of premature coronary heart disease. Results from a previous study showed that in India, 15% of the patients who had myocardial infarction at a young age also had familial hypercholesterolemia,3Sawhney JPS Prasad SR Sharma M et al.Prevalence of familial hypercholesterolemia in premature coronary artery disease patients admitted to a tertiary care hospital in North India.Indian Heart J. 2019; 71: 118-122Crossref PubMed Scopus (9) Google Scholar and similar studies showed a 10% prevalence of familial hypercholesterolemia in the USA and a 14·7% prevalence of the condition in Australia.4Singh A Gupta A Collins BL et al.Familial hypercholesterolemia among young adults with myocardial infarction.J Am Coll Cardiol. 2019; 73: 2439-2450Crossref PubMed Scopus (42) Google Scholar, 5Pang J Poulter EB Bell DA et al.Frequency of familial hypercholesterolemia in patients with early-onset coronary artery disease admitted to a coronary care unit.J Clin Lipidol. 2015; 9: 703-708Summary Full Text Full Text PDF PubMed Scopus (61) Google Scholar Once an individual is diagnosed with familial hypercholesterolemia, other family members should be identified by cascade screening by clinical history and lipid profiling rather than genetic testing, which is neither easily available nor affordable. Cascade screening has been proven to be a successful initiative towards primary prevention of coronary artery disease in India and other countries.6Setia N Saxena R Sawhney JPS Verma IC Familial hypercholesterolemia: cascade screening in children and relatives of the affected.Indian J Pediatr. 2018; 85: 339-343Crossref PubMed Scopus (12) Google Scholar, 7Knowles JW Rader DJ Khoury MJ Cascade screening for familial hypercholesterolemia and the use of genetic testing.JAMA. 2017; 318: 381-382Crossref PubMed Scopus (98) Google Scholar To prevent premature coronary heart disease, early screening at the family level, in which all the members share environmental and genetic factors, seems to be a good option to prevent premature coronary heart disease. Jeemon and colleagues’ study, by evaluating the presence and control of risk factors, is an attempt to encourage future studies to assess interventions such as screening at the primary level. Family-focused interventions help family members to act as a team in managing the disease in ways that are consistent with their beliefs. Interventions have been focused more on adherence to treatment and risk factor control than on family-behaviour variables. However, a previous study suggests that interventions focused on family relationships, rather than education of individual family members, might be an effective approach to improve the management of cardiovascular disease.8Satin W La Greca AM Zigo MA Skyler JS Diabetes in adolescence: effects of multifamily group intervention parent simulation of diabetes.J Pediatr Psychol. 1989; 14: 259-275Crossref PubMed Scopus (141) Google Scholar Educating family regarding the importance of controlling risk factors can prevent progression to clinical vascular disease (coronary artery disease, cerebrovascular disease, and peripheral vascular disease). In the future, studies should be done to compare the physical visits of community health workers versus mobile health interventions. JPSS reports honoraria for lectures and presentation from Novartis, Pfizer, Boehringer Ingelheim, Astrazeneca, Lupin, Merc, and Torrent. KM declares no competing interests. Efficacy of a family-based cardiovascular risk reduction intervention in individuals with a family history of premature coronary heart disease in India (PROLIFIC): an open-label, single-centre, cluster randomised controlled trialThe reduction of total cardiovascular risk observed after the intervention could have a substantial public health impact by preventing future cardiovascular events. Full-Text PDF Open Access
No takes yet. Share an insight, caveat, or question.
Sawhney et al. (2021) conducted an RCT in Family history of premature coronary heart disease (n=1,622). Family-based cardiovascular risk reduction intervention vs. Usual care was evaluated on Blood pressure <140/90 mm Hg, fasting plasma glucose <110 mg/dL, LDL cholesterol <100 mg/dL, and abstinence from tobacco (OR 2.2, 95% CI 1.7-2.7, p=<0.0001). A family-based cardiovascular risk reduction intervention significantly improved combined risk factor control at 2 years compared to usual care (64% vs 46%; OR 2.2; 95% CI 1.7-2.7; P<0.0001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: