Epidemiology and Biostatistics, University of Gondar College of Medicine and Health Sciences, Gondar, Ethiopia
Internal Medicine, University of Gondar, Gondar, Ethiopia.
BMJ Open. 2024 Aug 24;14(8):e084029. doi: 10.1136/bmjopen-2024-084029.
To evaluate effects of health extension workers-led home-based multicomponent intervention on blood pressure change in hypertensive patients in rural districts of northwest Ethiopia.
Two-arm cluster randomised controlled trial was conducted.
Hypertensive patients' age ≥25 years were included. 20 clusters or kebeles with 456 participants were randomly assigned to the intervention group (10 clusters with 228 participants) and the control group (10 clusters with 228 participants).
Participants in the intervention kebeles received health extension workers-led home-based multicomponent interventions every other month for 40-60 min for 9 months.
The primary outcomes were the differences in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) changes from baseline between patients in the intervention and control groups. Intention-to-treat analysis was used for the primary analyses. Linear mixed effect model was used to evaluate the intervention's effect on change in mean SBP and DBP. Effect sizes of mean difference and relative benefit increase were used.
At 9 months, the mean SBP decreased by 15.8 mm Hg (95% CI: 13.5, 18.1) in the intervention and 10.8 mm Hg (95% CI: 8.7, 12.9) in the control groups; with a 5.0 mm Hg (95% CI: 1.9, 8.1) greater reduction in the intervention group. The mean DBP decreased by 12.1 mm Hg (95% CI: 10.6, 13.5) in the intervention and 8.4 mm Hg (95% CI: 7.0, 9.8) in the control group. The proportion of optimal blood pressure control was higher in the intervention group (45.8%) than the control group (28.2%) with percentage difference of 17.6% (95% CI: 8.5, 26.7).
Health extension workers-led home-based multicomponent intervention has resulted significant reduction of blood pressure and achieved a higher proportion of optimal blood pressure control. This strategy is effective, but further research is needed to determine its cost effectiveness for scaling up and integrating in primary care settings.
The trial is registered with Pan African clinical trial registry (PACTR202102729454417).
评估健康推广员主导的家庭为基础的多组分干预对埃塞俄比亚西北部农村地区高血压患者血压变化的影响。
进行了一项双臂随机对照试验。
年龄≥25 岁的高血压患者被纳入研究。20 个村或 kebeles(相当于乡镇),共有 456 名参与者被随机分配到干预组(10 个村,228 名参与者)和对照组(10 个村,228 名参与者)。
干预村的参与者每隔一个月接受由健康推广员主导的家庭为基础的多组分干预,每次时长为 40-60 分钟,共进行 9 个月。
主要结局是干预组和对照组患者的收缩压(SBP)和舒张压(DBP)变化的平均差异。采用意向治疗分析进行主要分析。线性混合效应模型用于评估干预对 SBP 和 DBP 平均变化的影响。使用平均差异和相对获益增加的效应大小。
在 9 个月时,干预组的 SBP 平均下降 15.8mmHg(95%CI:13.5,18.1),对照组下降 10.8mmHg(95%CI:8.7,12.9);干预组的降幅更大,为 5.0mmHg(95%CI:1.9,8.1)。干预组的 DBP 平均下降 12.1mmHg(95%CI:10.6,13.5),对照组下降 8.4mmHg(95%CI:7.0,9.8)。干预组的血压控制最佳比例(45.8%)高于对照组(28.2%),差异百分比为 17.6%(95%CI:8.5,26.7)。
健康推广员主导的家庭为基础的多组分干预措施显著降低了血压,并实现了更高的血压控制最佳比例。该策略有效,但需要进一步研究来确定其在扩大规模和纳入初级保健环境中的成本效益。
该试验在泛非临床试验注册中心(PACTR202102729454417)注册。