Effectiveness of a nurse-led management intervention on systolic blood pressure among type 2 diabetes patients in Uganda: a cluster randomized trial.

William Lumu, Silver Bahendeka, Davis Kibirige, Ronald Wesonga, Ronald Kasoma Mutebi
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Abstract

Background: Hypertension (HT) is an orchestrator of atherosclerotic cardiovascular disease (ASCVD) in people living with type 2 diabetes (T2D). Control of systolic blood pressure (SBP) and HT as a whole is suboptimal in diabetes, partly due to the scarcity of doctors. While nurse-led interventions are pragmatic and cost-effective in the control of HT in primary health care, their effectiveness on SBP control among patients with T2D in Uganda is scantly known.

Aim: We evaluated the effectiveness of a nurse-led management intervention on SBP among T2D patients with a high ASCVD risk in Uganda.

Methods: A two-armed cluster randomized controlled trial compared the nurse-led management intervention with usual doctor-led care. The intervention involved training nurses to provide structured health education, protocol-based HT/CVD management, 24-h phone calls, and 2-monthly text messages for 6 months. The primary outcome was the mean difference in SBP change among patients with T2D with a high ASCVD risk in the intervention and control groups after 6 months. The secondary outcome was the absolute difference in the number of patients at target for SBP, total cholesterol (TC), fasting blood glucose (FBG), glycated hemoglobin (HbA1C), low-density lipoprotein (LDL), triglycerides (TG), and body mass index (BMI) after the intervention. The study was analyzed according to the intention-to-treat principle. Generalized estimating equations were used to assess intra-cluster effect modifiers. Statistical significance was set at 0.05 for all analyses.

Results: Eight clinics (n = 388 patients) were included (intervention 4 clinics; n = 192; control 4 clinics; n = 196). A nurse-led intervention reduced SBP by -11.21 ± 16.02 mmHg with a mean difference between the groups of -13.75 mmHg (95% CI -16.48 to -11.02, p < 0.001). An increase in SBP of 2.54 ± 10.95 mmHg was observed in the control group. Diastolic blood pressure was reduced by -6.80 ± 9.48 mmHg with a mean difference between groups of -7.20 mmHg (95% C1 -8.87 to -5.48, p < 0.001). The mean differences in the change in ASCVD score and glycated hemoglobin were -4.73% (95% CI -5.95 to -3.51, p = 0.006) and -0.82% (95% CI -1.30 to -0.35, p = 0.001), respectively. There were significant absolute differences in the number of patients at target in SBP (p = 0.001), DBP (p = 0.003), and TC (p = 0.008).

Conclusion: A nurse-led management intervention reduces SBP and ASCVD risk among patients with T2D. Such an intervention may be pragmatic in the screening and management of HT/ASCVD in Uganda.

Trial registration: Pan African Clinical Trial Registry, PACTR202001916873358, registered on 6th October 2019.

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乌干达 2 型糖尿病患者收缩压管理干预的效果:分组随机试验。
背景:高血压(HT)是 2 型糖尿病(T2D)患者动脉粥样硬化性心血管疾病(ASCVD)的致病因素。在糖尿病患者中,收缩压(SBP)和高血压的整体控制并不理想,部分原因是医生稀缺。虽然护士主导的干预措施在初级医疗保健中控制高血压方面具有实用性和成本效益,但其对乌干达 T2D 患者收缩压控制的效果却鲜为人知。目的:我们评估了护士主导的管理干预措施对乌干达 ASCVD 高风险 T2D 患者收缩压控制的效果:一项双臂分组随机对照试验比较了由护士主导的管理干预和由医生主导的常规护理。干预措施包括培训护士提供结构化健康教育、基于方案的高血压/心血管疾病管理、24 小时电话和两个月一次的短信,为期 6 个月。主要结果是干预组和对照组 ASCVD 高风险 T2D 患者 6 个月后 SBP 变化的平均差异。次要结果是干预后 SBP、总胆固醇 (TC)、空腹血糖 (FBG)、糖化血红蛋白 (HbA1C)、低密度脂蛋白 (LDL)、甘油三酯 (TG) 和体重指数 (BMI) 达到目标的患者人数的绝对差异。研究按照意向治疗原则进行分析。采用广义估计方程评估组内效应调节因子。所有分析的统计显著性均定为 0.05:共纳入 8 家诊所(n = 388 名患者)(干预 4 家诊所;n = 192;对照 4 家诊所;n = 196)。以护士为主导的干预措施使 SBP 降低了 -11.21 ± 16.02 mmHg,组间平均差异为 -13.75 mmHg(95% CI -16.48 至 -11.02,P以护士为主导的管理干预可降低 T2D 患者的 SBP 和 ASCVD 风险。在乌干达,这种干预措施在高血压/心血管系统疾病的筛查和管理中可能是实用的:泛非临床试验注册中心,PACTR202001916873358,注册日期:2019年10月6日。
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来源期刊
自引率
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发文量
7
审稿时长
8 weeks
期刊介绍: Clinical Diabetes and Endocrinology is an open access journal publishing within the field of diabetes and endocrine disease. The journal aims to provide a widely available resource for people working within the field of diabetes and endocrinology, in order to improve the care of people affected by these conditions. The audience includes, but is not limited to, physicians, researchers, nurses, nutritionists, pharmacists, podiatrists, psychologists, epidemiologists, exercise physiologists and health care researchers. Research articles include patient-based research (clinical trials, clinical studies, and others), translational research (translation of basic science to clinical practice, translation of clinical practice to policy and others), as well as epidemiology and health care research. Clinical articles include case reports, case seminars, consensus statements, clinical practice guidelines and evidence-based medicine. Only articles considered to contribute new knowledge to the field will be considered for publication.
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