Significant improvement in blood pressure control and related cardiovascular disease (CVD) risk is seen as a result of a potentially effective and pragmatic comprehensive model of care conducted as HOPE 4 trial (Heart Outcomes and Prevention Evaluation-4) presented by Dr. JD Schwalm at the European Society of Cardiology (ESC) Congress 2019 and simultaneously published in The LANCET.
If widely implemented, HOPE 4 strategy has a substantial potential of achieving the United Nations General Assembly Action Plan of a one-third reduction in the CVD associated premature mortality.
The HOPE-4 trial is a community-based, open-labeled, parallel, cluster, randomized controlled clinical trial led by non-physician health workers (NPHWs), including primary care physicians (PCPs) and informed families. It enrolled a total of 1371 participants with either new or poorly controlled hypertension from 30 communities in Colombia and Malaysia who were randomized in a 1:1 into the intervention or control group after community screening. Interventions (by comprehensive cardiovascular risk detection and management program) included treatment of cardiovascular disease risk factors by NPHWs using tablet computer-based simplified management algorithms and counseling programs; free antihypertensive and statin medications, and support from a family member or friend as a treatment supporter to improve adherence to medication and promote healthy behavior. A 12-month follow-up period was completed by all communities (data on 97% of living participants, n=1299) and there were no safety concerns with the intervention. The primary outcome was the change in Framingham Risk Score 10-year cardiovascular disease risk estimate at 12 months between intervention and control participants. Secondary outcomes included the change in systolic blood pressure (SBP), change in the proportion of participants with well-controlled SBP (< 140 mmHg) at 12 months, changes in HDL, LDL, total cholesterol, triglycerides, and glucose levels. Tertiary outcomes included the change in smoking and other healthy behavior, changes in INTERHEART risk score, medication adherence, and proportion of the participants receiving 2 or more antihypertensives and a statin at 6 and 12 months.
The results of this trial showed that Framingham Risk Score for 10-year cardiovascular disease risk was decreased by –6·40% (95% CI: 8·00 to –4·80) in the control group and –11·17% (–12·88 to –9·47) in the intervention group, with a difference of change of –4·78% (95% CI–7·11 to –2·44, p < 0·0001). There was an absolute 11·45 mm Hg (95% CI –14·94 to –7·97) greater reduction in SBP, and a 0·41 mmol/L (95% CI –0·60 to –0·23) reduction in LDL in the intervention group (both p < 0·0001). Change in blood pressure control status (< 140 mm Hg) was 69% in the intervention group versus 30% in the control group (p < 0·0001). There was no difference in the cholesterol & glucose levels, smoking cessation rates and weight in both groups at 12 months. Intervention group had higher adherence to the prescribed antihypertensives than the control group at 6 months (n=310 [56%] vs. n=172 [35%]; p < 0·0001) and 12 months (n=351 [61%] vs. n=200 [40%]; p < 0·0001). Intervention group benefited from most health behaviors with a marked reduction in the overall INTERHEART Risk Score at 6 months (–1·9 [SD 5·6] vs. –4·5 [SD 5·4]; p = 0·0008) and 12 months (–2·2 [SD 5·8] vs 4·8 [SD 5·4]; p < 0·0001).
HOPE-4 strategy was designed to overcome different barriers, including conflicting beliefs about alternative therapy, medication cost, time to see physicians, and poor adherence to recommendations at the patient level. Fragmented care & limited medication availability at the health system level and limited time adequacy to see and counsel the patients and limited use of 2 or more antihypertensives at the level of health care provider were found to be the other barriers.
Various factors responsible for the success of HOPE-4 NPHW-led strategy included simultaneous addressing of multiple barriers to cardiovascular disease risk factor management by a community-based intervention adapted carefully to local contexts, reinforcement of medication adherence and healthy behavior with the help of involvement of family and friends, and finally reduction of risk factors in the community along with the identification of people with undiagnosed or poorly managed HTN and CVD risk.