Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, Basel, Switzerland.
University of Basel, Basel, Switzerland.
Trials. 2024 Jun 6;25(1):365. doi: 10.1186/s13063-024-08226-2.
Arterial hypertension (aHT) is a major cause for premature morbidity and mortality. Control rates remain poor, especially in low- and middle-income countries. Task-shifting to lay village health workers (VHWs) and the use of digital clinical decision support systems may help to overcome the current aHT care cascade gaps. However, evidence on the effectiveness of comprehensive VHW-led aHT care models, in which VHWs provide antihypertensive drug treatment and manage cardiovascular risk factors is scarce.
Using the trials within the cohort (TwiCs) design, we are assessing the effectiveness of VHW-led aHT and cardiovascular risk management in two 1:1 cluster-randomized trials nested within the Community-Based chronic disease Care Lesotho (ComBaCaL) cohort study (NCT05596773). The ComBaCaL cohort study is maintained by trained VHWs and includes the consenting inhabitants of 103 randomly selected villages in rural Lesotho. After community-based aHT screening, adult, non-pregnant ComBaCaL cohort participants with uncontrolled aHT (blood pressure (BP) ≥ 140/90 mmHg) are enrolled in the aHT TwiC 1 and those with controlled aHT (BP < 140/90 mmHg) in the aHT TwiC 2. In intervention villages, VHWs offer lifestyle counseling, basic guideline-directed antihypertensive, lipid-lowering, and antiplatelet treatment supported by a tablet-based decision support application to eligible participants. In control villages, participants are referred to a health facility for therapeutic management. The primary endpoint for both TwiCs is the proportion of participants with controlled BP levels (< 140/90 mmHg) 12 months after enrolment. We hypothesize that the intervention is superior regarding BP control rates in participants with uncontrolled BP (aHT TwiC 1) and non-inferior in participants with controlled BP at baseline (aHT TwiC 2).
The TwiCs were launched on September 08, 2023. On May 20, 2024, 697 and 750 participants were enrolled in TwiC 1 and TwiC 2. To our knowledge, these TwiCs are the first trials to assess task-shifting of aHT care to VHWs at the community level, including the prescription of basic antihypertensive, lipid-lowering, and antiplatelet medication in Africa. The ComBaCaL cohort and nested TwiCs are operating within the routine VHW program and countries with similar community health worker programs may benefit from the findings.
ClinicalTrials.gov NCT05684055. Registered on January 04, 2023.
动脉高血压（aHT）是导致过早发病和死亡的主要原因。控制率仍然很低，特别是在低收入和中等收入国家。将任务转移给基层乡村卫生工作者（VHWs）并使用数字临床决策支持系统可能有助于克服当前的 aHT 护理级联差距。然而，关于 VHW 主导的全面 aHT 护理模式的有效性的证据很少，该模式中 VHW 提供抗高血压药物治疗并管理心血管危险因素。
我们使用试验内队列（TwiCs）设计，在嵌套于社区为基础的慢性病护理莱索托（ComBaCaL）队列研究中的两项 1:1 集群随机试验中评估 VHW 主导的 aHT 和心血管风险管理的效果（NCT05596773）。ComBaCaL 队列研究由经过培训的 VHW 维护，包括农村莱索托随机选择的 103 个村庄中同意参与的居民。在社区为基础的 aHT 筛查后，非妊娠的 ComBaCaL 队列参与者中血压（BP）未控制的成人（BP ≥ 140/90 mmHg）被纳入 aHT TwiC 1，BP 控制的参与者（BP < 140/90 mmHg）被纳入 aHT TwiC 2。在干预村庄中，VHW 提供生活方式咨询、基本指南指导的抗高血压、降脂和抗血小板治疗，由基于片剂的决策支持应用支持符合条件的参与者。在对照村庄中，参与者被转介到医疗机构进行治疗管理。两项 TwiCs 的主要终点均为在参与的 12 个月后，BP 控制水平（< 140/90 mmHg）的参与者比例。我们假设该干预措施在血压未控制的参与者（aHT TwiC 1）中控制血压的比例更高，而在基线时血压控制的参与者（aHT TwiC 2）中不劣。
TwiCs 于 2023 年 9 月 8 日启动。截至 2024 年 5 月 20 日，TwiC 1 和 TwiC 2 分别招募了 697 名和 750 名参与者。据我们所知，这些 TwiCs 是首次评估将 aHT 护理任务转移到社区一级的 VHW 的试验，包括在非洲开具基本抗高血压、降脂和抗血小板药物。ComBaCaL 队列和嵌套的 TwiCs 在常规 VHW 计划内运行，具有类似社区卫生工作者计划的国家可能会从这些发现中受益。
ClinicalTrials.gov NCT05684055。于 2023 年 1 月 4 日注册。
