Abstract
Coronary heart disease, a leading cause of death globally, is amenable to lifestyle interventions. The family environment can affect the ability or willingness of individuals to make lifestyle changes. We aimed to investigate the efficacy of a targeted family-based intervention for reduction of total cardiovascular risk in individuals with a family history of premature coronary heart disease. We did an open-label, cluster randomised controlled trial (PROLIFIC) in the families (first-degree relatives and spouses, older than age 18 years) of individuals with coronary heart disease who had been diagnosed before age 55 years. Patients with coronary heart disease diagnosed within the past year were selected from a tertiary care speciality hospital that provides care for patients from Kerala, India. Family members of selected patients who were bedridden or terminally ill, and individuals with a history of established cardiovascular heart disease and stroke were excluded, as were families with fewer than two eligible family members. Simple randomisation with computer-generated random numbers was used to randomly assign families to intervention and usual care groups (1:1). Participants in the intervention group received a comprehensive package of interventions facilitated by non-physician health workers, consisting of: screening for cardiovascular risk factors; structured lifestyle interventions; linkage to a primary health-care facility for individuals with established chronic disease risk factors or conditions; and active follow-up for adherence. The usual care group received one-time counselling and annual screening for risk factors. We obtained data on lifestyle, clinical, and biochemical characteristics at baseline and annually during the 2-year follow-up. The primary outcome was achievement or maintenance of any three of the following: 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. The primary outcome was analysed in all participants available for follow-up at the relevant timepoint. This trial is registered with Clinicaltrials.gov, NCT02771873. From Jan 1, 2015, to April 30, 2017, 980 patients with coronary heart disease were assessed for eligibility and 230 were excluded primarily due to lack of evidence of coronary artery disease (n=199), or a diagnosis of coronary heart disease more than 1 year previously (n=29). Of the 750 remaining families, 368 (with 825 participants) were assigned to the intervention group and 382 (with 846 participants) were assigned to the usual care group. At the 2-year follow-up, data from 803 (97%) of 825 participants in the intervention group and 819 (97%) of 846 participants in the usual care group were available. Of the 1671 participants, 1111 (66·5%) were women, and 560 (33·5%) were men. The mean age of the study population was 40·8 years (SD 14·2). At the 2-year follow-up, the primary outcome was achieved by 514 (64%) of 803 participants in the intervention group and 379 (46%) of 819 in the usual care group. After adjustment for clustering and baseline risk factors, the odds of achieving the primary outcome at the 2-year timepoint was two times higher in the intervention group than in the usual care group (odds ratio 2·2, 95% CI 1·7-2·7; p<0·0001). The reduction of total cardiovascular risk observed after the intervention could have a substantial public health impact by preventing future cardiovascular events. The Wellcome Trust and Department of Biotechnology, Government of India, and India Alliance.
Highlights
Coronary heart disease is a major public health problem worldwide, contributing to 180 million disability-adjusted life years and 9·14 million deaths annually.[1]
After adjustment for clustering and baseline risk factors, the odds of achieving the primary outcome at the 2-year timepoint was two times higher in the intervention group than in the usual care group
From Jan 1, 2015, to April 30, 2017, we reviewed the medical records of 980 patients with coronary heart disease to assess eligibility. 230 patients were excluded, comprising two families who did not consent to participation, 199 patients who lacked documented evidence of coronary heart disease, and 29 who were diagnosed with coronary heart disease more than 1 year previously
Summary
Coronary heart disease is a major public health problem worldwide, contributing to 180 million disability-adjusted life years and 9·14 million deaths annually.[1]. Evidence before this study Methodologically rigorous evaluations of family-based lifestyle interventions for the reduction of chronic disease in adults are scarce. Available studies of several different chronic conditions such as childhood asthma, diabetes, and hypertension, indicate a growing recognition of the importance of family-based approaches in reducing the burden of chronic diseases. We searched MEDLINE for studies published in English of family-based interventions in coronary heart disease published up to Jan 31, 2021, using the terms “((family-based intervention) OR (family-based intervention) OR (family intervention) AND (coronary heart disease [MeSH Major Topic])) AND (randomised controlled trials [MeSH Major Topic]) OR (randomized controlled trials [MeSH Major Topic])”, but did not identify any relevant articles. Added value of this study The PROLIFIC trial, a single-centre, open-label, cluster randomised controlled trial in Kerala, India, shows the efficacy of a family-based intensive intervention in reducing cardiovascular risk in individuals with a family history of premature coronary heart disease. The intervention was effective in all individuals irrespective of their sex, age, and baseline risk factors
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