Health Services Research & Pharmacoepidemiology Unit, Fundació per al Foment de la Investigació Sanitària i Biomèdica de la Comunitat Valenciana (Fisabio), Valencia, Spain.
Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Spain.
JAMA Netw Open. 2024 May 1;7(5):e2410063. doi: 10.1001/jamanetworkopen.2024.10063.
Patient empowerment through pharmacologic self-management is a common strategy for some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure (BP). Several trials have shown its potential for reducing BP in the short term, but evidence in the longer term is scarce.
To evaluate the longer-term effectiveness of BP self-monitoring plus self-titration of antihypertensive medication vs usual care for patients with poorly controlled hypertension, with passive follow-up and primary-care nursing involvement.
DESIGN, SETTING, AND PARTICIPANTS: The ADAMPA (Impact of Self-Monitoring of Blood Pressure and Self-Titration of Medication in the Control of Hypertension) study was a randomized, unblinded clinical trial with 2 parallel arms conducted in Valencia, Spain. Included participants were patients 40 years or older, with systolic BP (SBP) over 145 mm Hg and/or diastolic BP (DBP) over 90 mm Hg, recruited from July 21, 2017, to June 30, 2018 (study completion, August 25, 2020). Statistical analysis was conducted on an intention-to-treat basis from August 2022 to February 2024.
Participants were randomized 1:1 to usual care vs an individualized, prearranged plan based on BP self-monitoring plus medication self-titration.
The main outome was the adjusted mean difference (AMD) in SBP between groups at 24 months of follow-up. Secondary outcomes were the AMD in DBP between groups at 24 months of follow-up, proportion of patients reaching the BP target (SBP <140 mm Hg and DBP <90 mm Hg), change in behaviors, quality of life, health service use, and adverse events.
Among 312 patients included in main trial, data on BP measurements at 24 months were available for 219 patients (111 in the intervention group and 108 in the control group). The mean (SD) age was 64.3 (10.1) years, and 120 patients (54.8%) were female; the mean (SD) SBP was 155.6 (13.1) mm Hg, and the mean (SD) diastolic BP was 90.8 (7.7) mm Hg. The median follow-up was 23.8 months (IQR, 19.8-24.5 months). The AMD in SBP at the end of follow-up was -3.4 mm Hg (95% CI, -4.7 to -2.1 mm Hg; P < .001), and the AMD in DBP was -2.5 mm Hg (95% CI, -3.5 to -1.6 mm Hg; P < .001). Subgroup analysis for the main outcome showed consistent results. Sensitivity analyses confirmed the robustness of the main findings. No differences were observed between groups in behaviors, quality of life, use of health services, or adverse events.
In this secondary analysis of a randomized clinical trial, BP self-monitoring plus self-titration of antihypertensive medication based on an individualized prearranged plan used in primary care reduced BP in the longer term with passive follow-up compared with usual care, without increasing health care use or adverse events. These results suggest that simple, inexpensive, and easy-to-implement self-management interventions have the potential to improve the long-term control of hypertension in routine clinical practice.
ClinicalTrials.gov Identifier: NCT03242785.
通过药物自我管理实现患者赋权是控制糖尿病等慢性病的常见策略,但很少用于控制血压(BP)。几项试验已经证明了其在短期内降低血压的潜力,但长期证据很少。
评估血压自我监测加降压药物自我滴定与常规护理相比,在被动随访和初级保健护理参与的情况下,对血压控制不佳的患者的长期有效性。
设计、地点和参与者:ADAMPA(血压自我监测和药物自我滴定对高血压控制的影响)研究是一项在西班牙巴伦西亚进行的随机、非盲临床试验,有 2 个平行组。纳入的参与者为年龄在 40 岁及以上、收缩压(SBP)超过 145mmHg 和/或舒张压(DBP)超过 90mmHg 的患者,于 2017 年 7 月 21 日至 2018 年 6 月 30 日(研究完成日期为 2020 年 8 月 25 日)招募。从 2022 年 8 月到 2024 年 2 月进行了意向治疗的统计分析。
参与者以 1:1 的比例随机分为常规护理组与基于血压自我监测加药物自我滴定的个体化预先安排计划组。
主要结局是 24 个月随访时两组间 SBP 的调整平均差异(AMD)。次要结局是 24 个月随访时两组间 DBP 的 AMD、达到血压目标(SBP<140mmHg 和 DBP<90mmHg)的患者比例、行为变化、生活质量、卫生服务使用和不良事件的变化。
在主要试验的 312 名纳入患者中,有 219 名患者(干预组 111 名,对照组 108 名)提供了 24 个月的血压测量数据。患者的平均(SD)年龄为 64.3(10.1)岁,120 名患者(54.8%)为女性;平均(SD)SBP 为 155.6(13.1)mmHg,平均(SD)DBP 为 90.8(7.7)mmHg。中位随访时间为 23.8 个月(IQR,19.8-24.5 个月)。随访结束时 SBP 的 AMD 为-3.4mmHg(95%CI,-4.7 至-2.1mmHg;P<0.001),DBP 的 AMD 为-2.5mmHg(95%CI,-3.5 至-1.6mmHg;P<0.001)。主要结局的亚组分析显示出一致的结果。敏感性分析证实了主要发现的稳健性。两组在行为、生活质量、卫生服务使用或不良事件方面无差异。
在这项随机临床试验的二次分析中,基于个体化预先安排计划的降压药物自我滴定与常规护理相比,在被动随访下,在初级保健中使用血压自我监测可在长期内降低血压,而不会增加医疗保健使用或不良事件。这些结果表明,简单、廉价且易于实施的自我管理干预措施有可能改善常规临床实践中高血压的长期控制。
ClinicalTrials.gov 标识符:NCT03242785。