Background

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.

Methods

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.

Findings

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).

Interpretation

The reduction of total cardiovascular risk observed after the intervention could have a substantial public health impact by preventing future cardiovascular events.

Funding

The Wellcome Trust and Department of Biotechnology, Government of India, and India Alliance.

中文翻译：

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以家庭为基础的心血管风险降低干预对印度有早发冠心病家族史的个体的疗效 (PROLIFIC)：一项开放标签、单中心、整群随机对照试验

背景

冠心病是全球主要的死亡原因，可以通过生活方式干预。家庭环境会影响个人改变生活方式的能力或意愿。我们旨在调查有针对性的基于家庭的干预对降低有早发冠心病家族史的个体的总心血管风险的有效性。

方法

我们在 55 岁之前被诊断出患有冠心病的个体的家庭（一级亲属和配偶，年龄大于 18 岁）中进行了一项开放标签、整群随机对照试验 (PROLIFIC)。在过去一年内诊断出患有冠心病的患者是从一家为印度喀拉拉邦患者提供护理的三级护理专科医院中挑选出来的。选定的卧床不起或身患绝症的患者的家庭成员以及有明确心血管心脏病和中风病史的个人被排除在外，符合条件的家庭成员少于两个的家庭也被排除在外。使用计算机生成的随机数进行简单随机化，将家庭随机分配到干预组和常规护理组 (1:1)。干预组的参与者接受了由非医生卫生工作者协助的一揽子综合干预措施，包括： 筛查心血管危险因素；结构化生活方式干预；与已确定慢性病风险因素或病症的个人的初级卫生保健机构建立联系；并积极跟进依从性。常规护理组接受一次性咨询和风险因素年度筛查。我们在 2 年随访期间获得了基线时和每年的生活方式、临床和生化特征数据。主要结局是达到或维持以下任何三项：血压低于 140/90 mmHg，空腹血糖低于 110 mg/dL，低密度脂蛋白胆固醇低于 100 mg/dL，以及戒烟. 在相关时间点进行随访的所有参与者中分析了主要结果。该试验已在 Clinicaltrials.gov 注册，NCT02771873。

发现

从2015年1月1日至2017年4月30日，980名冠心病患者被评估为合格，230名主要由于缺乏冠心病证据（n=199）或冠心病诊断更多而被排除比 1 年前（n = 29）。在剩余的 750 个家庭中，368 个（825 名参与者）被分配到干预组，382 个（846 名参与者）被分配到常规护理组。在 2 年的随访中，可以获得干预组 825 名参与者中的 803 名 (97%) 和常规护理组 846 名参与者中的 819 名 (97%) 的数据。在 1671 名参与者中，1111 人 (66·5%) 是女性，560 人 (33·5%) 是男性。研究人群的平均年龄为 40·8 岁 (SD 14·2)。在 2 年的随访中，干预组 803 名参与者中的 514 名 (64%) 和常规护理组 819 名参与者中的 379 名 (46%) 实现了主要结果。在调整聚类和基线风险因素后，干预组在 2 年时间点实现主要结局的几率是常规治疗组的两倍（几率比 2·2，95% CI 1·7– 2·7；p<0·0001)。

解释

干预后观察到的总心血管风险降低可能通过预防未来的心血管事件对公共健康产生重大影响。

资金

Wellcome Trust 和生物技术部、印度政府和印度联盟。