Shimada Hideaki, Okamura Keisuke, Ohyama Tetsuji, Urata Hidenori, Imakyure Osamu
Clinical Research Support Center, Fukuoka University Chikushi Hospital, Chikushino, Fukuoka, Japan.
Department of Cardiology and Cardiovascular Center, Imamura Hospital, Tosu, Saga, Japan.
J Clin Med Res. 2025 May;17(5):247-255. doi: 10.14740/jocmr6252. Epub 2025 May 28.
When performing clinical trials on lifestyle-related diseases at our hospital, we have sometimes experienced patients who fulfilled the inclusion criteria at the time of receiving an explanation of the trial but who no longer met the criteria when they arrived to provide their consent to participate 1 month later. In some of these cases, we noticed that the patient's lifestyle subsequently improved. Therefore, we hypothesized that receiving information on clinical trials may affect lifestyle-related diseases.
We enrolled patients aged 85 years or younger who received information on a double-blind randomized clinical trial on treatment-resistant hypertension (R-HT) or one on diabetic nephropathy. In these patients, we evaluated whether the trial information affected a range of variables. In addition, we compared the rate of change in variables between two groups, i.e., patients who became ineligible to participate and were not randomized (early dropouts) and patients who decided to participate and were randomized (patients randomized to treatment). We also conducted a questionnaire on changes in patients' motivation level, health awareness and behavior, and expectations and concerns and evaluated changes from before to after receiving an explanation of the trial.
Seven patients who received an explanation of the R-HT trial and 14 who received an explanation of the diabetic nephropathy trial participated in the present study. The only significant change in any variable was in the R-HT clinical trial, where systolic and diastolic blood pressure significantly decreased in the early dropout group. There were no significant differences between the two groups in the rate of change in variables. After receiving information about one of the studies, patients who became more proactive or involved in changing their health-related behavior, such as their exercise, eating, and drinking habits, increased in both groups.
Receiving information on a clinical trial on hypertension can significantly affect blood pressure. Future research should examine whether providing information on clinical trials on other lifestyle-related diseases motivates patients to improve their lifestyles.
在我院进行与生活方式相关疾病的临床试验时，我们有时会遇到这样的患者，他们在接受试验解释时符合纳入标准，但在1个月后前来签署参与同意书时却不再符合标准。在其中一些案例中，我们注意到患者的生活方式随后有所改善。因此，我们推测接收临床试验信息可能会影响与生活方式相关的疾病。
我们纳入了85岁及以下且接收了关于难治性高血压（R-HT）或糖尿病肾病双盲随机临床试验信息的患者。在这些患者中，我们评估了试验信息是否会影响一系列变量。此外，我们比较了两组之间变量的变化率，即不符合参与条件且未被随机分组的患者（早期退出者）和决定参与并被随机分组的患者（随机接受治疗的患者）。我们还就患者的动机水平、健康意识和行为以及期望和担忧的变化进行了问卷调查，并评估了从接受试验解释前到接受解释后这些方面的变化。
7名接受了R-HT试验解释的患者和14名接受了糖尿病肾病试验解释的患者参与了本研究。任何变量中唯一显著的变化发生在R-HT临床试验中，早期退出组的收缩压和舒张压显著下降。两组之间变量的变化率没有显著差异。在接收了其中一项研究的信息后，两组中在运动、饮食和饮酒习惯等与健康相关行为改变方面变得更加积极或主动的患者都有所增加。
接收高血压临床试验信息可显著影响血压。未来的研究应探讨提供其他与生活方式相关疾病的临床试验信息是否能促使患者改善其生活方式。
