PDF(Pubmed)
Abstract：
BACKGROUND: The high prevalence of uncontrolled hypertension in Pakistan is predominantly attributed to poor medication adherence. As more than 137 million people in Pakistan use cell phones, a suitable mobile health (mHealth) intervention can be an effective tool to overcome poor medication adherence.
OBJECTIVE: We sought to determine whether a novel mHealth intervention is useful in enhancing antihypertensive therapy adherence and treatment outcomes among patients with hypertension in a low- to middle-income country.
METHODS: A 6-month parallel, single-blinded, superiority randomized controlled trial recruited 439 patients with hypertension with poor adherence to antihypertensive therapy and access to smartphones. An innovative, multifaceted mHealth intervention (Multi-Aid-Package), based on the Health Belief Model and containing reminders (written, audio, visual), infographics, video clips, educational content, and 24/7 individual support, was developed for the intervention group; the control group received standard care. The primary outcome was self-reported medication adherence measured using the Self-Efficacy for Appropriate Medication Adherence Scale (SEAMS) and pill counting; the secondary outcome was systolic blood pressure (SBP) change. Both outcomes were evaluated at baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. A generalized estimating equation was used to control the covariates associated with the probability of affecting adherence to antihypertensive medication.
RESULTS: Of 439 participants, 423 (96.4%) completed the study. At 6 months post intervention, the median SEAMS score was statistically significantly higher in the intervention group compared to the controls (median 32, IQR 11 vs median 21, IQR 6; U=10,490, P<.001). Within the intervention group, there was an increase in the median SEAMS score by 12.5 points between baseline and 6 months (median 19.5, IQR 5 vs median 32, IQR 11; P<.001). Results of the pill-counting method showed an increase in adherent patients in the intervention group compared to the controls (83/220, 37.2% vs 2/219, 0.9%; P<.001), as well as within the intervention group (difference of n=83, 37.2% of patients, baseline vs 6 months; P<.001). There was a statistically significant difference in the SBP of 7 mmHg between the intervention and control groups (P<.001) at 6 months, a 4 mmHg reduction (P<.001) within the intervention group, and a 3 mmHg increase (P=.314) within the controls. Overall, the number of patients with uncontrolled hypertension decreased by 46 in the intervention group (baseline vs 6 months), but the control group remained unchanged. The variables groups (adjusted odds ratio [AOR] 1.714, 95% CI 2.387-3.825), time (AOR 1.837, 95% CI 1.625-2.754), and age (AOR 1.618, 95% CI 0.225-1.699) significantly contributed (P<.001) to medication adherence. Multi-Aid-Package received a 94.8% acceptability score.
CONCLUSIONS: The novel Multi-Aid-Package is an effective mHealth intervention for enhancing medication adherence and treatment outcomes among patients with hypertension in a low- to middle-income country.
BACKGROUND: ClinicalTrials.gov NCT04577157; https://clinicaltrials.gov/study/NCT04577157.
OBJECTIVE: We sought to determine whether a novel mHealth intervention is useful in enhancing antihypertensive therapy adherence and treatment outcomes among patients with hypertension in a low- to middle-income country.
METHODS: A 6-month parallel, single-blinded, superiority randomized controlled trial recruited 439 patients with hypertension with poor adherence to antihypertensive therapy and access to smartphones. An innovative, multifaceted mHealth intervention (Multi-Aid-Package), based on the Health Belief Model and containing reminders (written, audio, visual), infographics, video clips, educational content, and 24/7 individual support, was developed for the intervention group; the control group received standard care. The primary outcome was self-reported medication adherence measured using the Self-Efficacy for Appropriate Medication Adherence Scale (SEAMS) and pill counting; the secondary outcome was systolic blood pressure (SBP) change. Both outcomes were evaluated at baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. A generalized estimating equation was used to control the covariates associated with the probability of affecting adherence to antihypertensive medication.
RESULTS: Of 439 participants, 423 (96.4%) completed the study. At 6 months post intervention, the median SEAMS score was statistically significantly higher in the intervention group compared to the controls (median 32, IQR 11 vs median 21, IQR 6; U=10,490, P<.001). Within the intervention group, there was an increase in the median SEAMS score by 12.5 points between baseline and 6 months (median 19.5, IQR 5 vs median 32, IQR 11; P<.001). Results of the pill-counting method showed an increase in adherent patients in the intervention group compared to the controls (83/220, 37.2% vs 2/219, 0.9%; P<.001), as well as within the intervention group (difference of n=83, 37.2% of patients, baseline vs 6 months; P<.001). There was a statistically significant difference in the SBP of 7 mmHg between the intervention and control groups (P<.001) at 6 months, a 4 mmHg reduction (P<.001) within the intervention group, and a 3 mmHg increase (P=.314) within the controls. Overall, the number of patients with uncontrolled hypertension decreased by 46 in the intervention group (baseline vs 6 months), but the control group remained unchanged. The variables groups (adjusted odds ratio [AOR] 1.714, 95% CI 2.387-3.825), time (AOR 1.837, 95% CI 1.625-2.754), and age (AOR 1.618, 95% CI 0.225-1.699) significantly contributed (P<.001) to medication adherence. Multi-Aid-Package received a 94.8% acceptability score.
CONCLUSIONS: The novel Multi-Aid-Package is an effective mHealth intervention for enhancing medication adherence and treatment outcomes among patients with hypertension in a low- to middle-income country.
BACKGROUND: ClinicalTrials.gov NCT04577157; https://clinicaltrials.gov/study/NCT04577157.
摘要：
背景：巴基斯坦不受控制的高血压的高患病率主要归因于药物依从性差。巴基斯坦有超过1.37亿人使用手机，合适的移动医疗(mHealth)干预措施可以成为克服药物依从性差的有效工具.
目的：我们试图确定一种新型的mHealth干预措施是否有助于提高中低收入国家高血压患者的抗高血压治疗依从性和治疗结果。
方法：6个月平行，单盲,优势随机对照试验纳入了439例高血压患者,这些患者对抗高血压治疗和智能手机的依从性较差.一个创新的,多方面的健康干预(多援助包)，基于健康信念模型并包含提醒(书面，音频,视觉)，信息图表,视频剪辑,教育内容,和24/7个人支持，为干预组开发；对照组接受标准护理。主要结果是使用适当药物依从性自我效能量表（SEAMS）和药丸计数测量的自我报告的药物依从性；次要结果是收缩压（SBP）变化。在基线和6个月时评估两种结果。在研究结束时还评估了技术接受反馈。使用广义估计方程来控制与影响抗高血压药物依从性的概率相关的协变量。
结果：在439名参与者中，423人（96.4%）完成研究。干预后6个月，干预组的SEAMS评分中位数高于对照组(中位数32,IQR11vs中位数21,IQR6;U=10,490,P<.001).在干预组中，基线和6个月之间的中位SEAMS评分增加了12.5分(中位数19.5,IQR5,中位数32,IQR11;P<.001).药丸计数方法的结果显示，与对照组相比，干预组的粘附患者增加（83/220，37.2%vs2/219，0.9%；P<.001），以及干预组内(差异n=83，37.2%的患者，基线vs6个月；P<.001）。干预组与对照组在6个月时SBP为7mmHg,差异有统计学意义(P<.001),干预组内降低4mmHg(P<.001)，和3mmHg的增加（P=.314）在对照组。总的来说,干预组高血压未控制的患者人数减少了46人（基线vs6个月），但对照组保持不变。变量组(调整后的比值比[AOR]1.714，95%CI2.387-3.825)，时间（AOR1.837，95%CI1.625-2.754），和年龄（AOR1.618，95％CI0.225-1.699）显着贡献（P<.001）的药物依从性。多重援助方案获得了94.8%的可接受性评分。
结论：新的多援助方案是一种有效的mHealth干预措施，可提高中低收入国家高血压患者的用药依从性和治疗效果。
背景：ClinicalTrials.govNCT04577157;https://clinicaltrials.gov/study/NCT04577157。
目的：我们试图确定一种新型的mHealth干预措施是否有助于提高中低收入国家高血压患者的抗高血压治疗依从性和治疗结果。
方法：6个月平行，单盲,优势随机对照试验纳入了439例高血压患者,这些患者对抗高血压治疗和智能手机的依从性较差.一个创新的,多方面的健康干预(多援助包)，基于健康信念模型并包含提醒(书面，音频,视觉)，信息图表,视频剪辑,教育内容,和24/7个人支持，为干预组开发；对照组接受标准护理。主要结果是使用适当药物依从性自我效能量表（SEAMS）和药丸计数测量的自我报告的药物依从性；次要结果是收缩压（SBP）变化。在基线和6个月时评估两种结果。在研究结束时还评估了技术接受反馈。使用广义估计方程来控制与影响抗高血压药物依从性的概率相关的协变量。
结果：在439名参与者中，423人（96.4%）完成研究。干预后6个月，干预组的SEAMS评分中位数高于对照组(中位数32,IQR11vs中位数21,IQR6;U=10,490,P<.001).在干预组中，基线和6个月之间的中位SEAMS评分增加了12.5分(中位数19.5,IQR5,中位数32,IQR11;P<.001).药丸计数方法的结果显示，与对照组相比，干预组的粘附患者增加（83/220，37.2%vs2/219，0.9%；P<.001），以及干预组内(差异n=83，37.2%的患者，基线vs6个月；P<.001）。干预组与对照组在6个月时SBP为7mmHg,差异有统计学意义(P<.001),干预组内降低4mmHg(P<.001)，和3mmHg的增加（P=.314）在对照组。总的来说,干预组高血压未控制的患者人数减少了46人（基线vs6个月），但对照组保持不变。变量组(调整后的比值比[AOR]1.714，95%CI2.387-3.825)，时间（AOR1.837，95%CI1.625-2.754），和年龄（AOR1.618，95％CI0.225-1.699）显着贡献（P<.001）的药物依从性。多重援助方案获得了94.8%的可接受性评分。
结论：新的多援助方案是一种有效的mHealth干预措施，可提高中低收入国家高血压患者的用药依从性和治疗效果。
背景：ClinicalTrials.govNCT04577157;https://clinicaltrials.gov/study/NCT04577157。
