Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.
Department of Public Health, Institute of Social and Cultural Studies, University of Punjab, Lahore, Pakistan.
Trials. 2023 Jul 10;24(1):448. doi: 10.1186/s13063-023-07472-0.
Hypertension is a highly relevant public health challenge. Digital interventions may support improving adherence to anti-hypertensive medications and alter health behavior. Therefore, this protocol describes a study that aims to assess the effectiveness of mHealth and educational support through peer counseling (Ed-counselling) to control blood pressure in hypertensive patients when compared to standard care.
We chose a double-blinded pragmatic randomized-controlled with factorial design for this investigation. The trial is going to recruit 1648 hypertensive patients with coronary artery disease at the age of 21 to 70 years. All participants will already be on anti-hypertensive medication and own a smartphone. They will be randomized into four groups with each having 412 participants. The first group will only receive standard care; while the second group, in addition to standard care, will receive monthly Ed-counselling (educational booklets with animated infographics and peer counseling); the third group will receive daily written and voice reminders and an education-led video once weekly together with standard care; while the fourth one gets both interventions given to second and third groups respectively. All groups will be followed-up for 1 year (0, 6, and 12 months). The primary outcome will be the change in systolic blood pressure while secondary outcomes include health-related quality of life and changes in medication adherence. For measuring changes in systolic blood pressure (SBP) and adherence scores difference at 0, 6, and 12 months between and within the group, parametric (ANOVA/repeated measure ANOVA) and non-parametric tests (Kruskal-Wallis test/Friedman test) will be used. By using the general estimating equation (GEE) with negative binomial regression, at 12 months, the covariates affecting primary and secondary outcomes will be determined and controlled. The analysis will be intention-to-treat. All the outcomes will be analyzed at 0, 6, and 12 months; however, the final analysis will be at 12 months from baseline.
Besides adding up to existing evidence in the literature on the subject, our designed modules using mHealth technology can help in reducing hypertension-related morbidity and mortality in developing countries.
高血压是一个非常重要的公共卫生挑战。数字干预措施可能有助于提高抗高血压药物的依从性,并改变健康行为。因此,本方案描述了一项旨在评估通过移动健康和同伴咨询(教育咨询)进行教育支持以控制高血压患者血压的研究,与标准护理相比,该研究的效果。
我们选择了一项双盲实用随机对照的析因设计来进行这项研究。该试验将招募年龄在 21 至 70 岁之间、患有冠状动脉疾病的 1648 名高血压患者。所有参与者都已经在服用抗高血压药物,并且拥有智能手机。他们将随机分为四组,每组 412 人。第一组仅接受标准护理;第二组除标准护理外,每月接受教育咨询(带动画图表的教育手册和同伴咨询);第三组接受每日书面和语音提醒以及每周一次的教育主导视频,同时接受标准护理;第四组分别接受第二组和第三组的两项干预措施。所有组将随访 1 年(0、6 和 12 个月)。主要结局是收缩压的变化,次要结局包括与健康相关的生活质量和药物依从性的变化。为了测量 0、6 和 12 个月时收缩压(SBP)和依从性评分差异的变化,将使用参数(方差分析/重复测量方差分析)和非参数检验(Kruskal-Wallis 检验/弗里德曼检验)。使用一般估计方程(GEE)和负二项回归,在 12 个月时,将确定和控制影响主要和次要结局的协变量。分析将采用意向治疗。所有结局将在 0、6 和 12 个月时进行分析;然而,最终分析将在从基线开始的 12 个月时进行。
除了增加现有文献中关于该主题的证据外,我们使用移动健康技术设计的模块可以帮助减少发展中国家与高血压相关的发病率和死亡率。