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A telephone reminder to enhance adherence to interventions in cardiovascular randomized trials: A protocol for a study within a trial (SWAT).
Journal of Evidence-Based Medicine ( IF 7.3 ) Pub Date : 2020-02-01 , DOI: 10.1111/jebm.12375
Abdelsalam Bensaaud 1 , Irene Gibson 2 , Jennifer Jones 3 , Gerard Flaherty 2 , Sherif Sultan 1 , Wael Tawfick 1 , Fionnuala Jordan 4
Affiliation  

The impact of reduced adherence in randomized clinical trials is well documented in the literature. Nonadherence can negatively affect the trial sample size and estimation of the treatment effect. This protocol aims to evaluate the effects of a telephone call reminder on the adherence rates of participants to interventions in a cardiovascular randomized trial. This is a study within a trial (SWAT). The host trial is evaluating the effectiveness of a multidisciplinary 16‐wk cardiovascular disease prevention program on risk factor profile among patients with carotid artery stenosis. Simultaneously, this SWAT will evaluate the effectiveness of telephone call reminders on the participants’ adherence to the host trial intervention. The primary outcome is adherence to the protocol of the host trial. Secondary outcomes are level of adherence, number of dropouts, and time to drop out from the host trial.

中文翻译:

电话提醒,以增强对心血管随机试验干预措施的依从性:一项试验内研究方案(SWAT)。

随机临床试验中依从性降低的影响已在文献中充分记录。不坚持可能会对试验样品的大小和治疗效果的估计产生负面影响。该协议旨在评估电话提醒对参与者参加心血管随机试验干预措施的依从率的影响。这是一项试验内的研究(SWAT)。这项宿主试验正在评估一项多学科的16周心血管疾病预防计划在颈动脉狭窄患者中危险因素分布方面的有效性。同时,该SWAT将评估参与者遵守主持人试验干预措施的电话提醒的有效性。主要结果是遵守宿主试验方案。次要结果是坚持程度,
更新日期:2020-02-01
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