@Article{信息:doi 10.2196 / / jmir。6417,作者=“Kannisto, Kati Anneli和Korhonen, Joonas和Adams, Clive E和Koivunen, Marita Hannele和Vahlberg, Tero和V{\"a}lim{\"a}ki, Maritta Anneli”,标题=“基于移动医疗的随机对照试验的招募和随访期间的退出相关因素。网站鼓励有严重精神健康问题的人坚持治疗",期刊="J Med Internet Res",年="2017",月="2",日="21",卷="19",数="2",页="e46",关键词="短信;移动健康;抗精神病药物;心理健康;精神病学服务;背景:临床试验是循证实践的金标准。仍然有许多论文对随机对照试验(rct)的方法报道不足,特别是对有严重精神健康问题的人的移动健康干预。为了确保足够有力的证据,了解哪些研究阶段在精神卫生保健领域是最脆弱的是很重要的。目的:我们绘制了参与者的招募和试验随访期,以提供基于mhealth的试验的退出预测因素的图片。 As an example, we used a mHealth-based multicenter RCT, titled ``Mobile.Net,'' targeted at people with serious mental health problems. Methods: Recruitment and follow-up processes of the Mobile.Net trial were monitored and analyzed. Recruitment outcomes were recorded as screened, eligible, consent not asked, refused, and enrolled. Patient engagement was recorded as follow-up outcomes: (1) attrition during short message service (SMS) text message intervention and (2) attrition during the 12-month follow-up period. Multiple regression analysis was used to identify which demographic factors were related to recruitment and retention. Results: We recruited 1139 patients during a 15-month period. Of 11,530 people screened, 36.31{\%} (n=4186) were eligible. This eligible group tended to be significantly younger (mean 39.2, SD 13.2 years, P<.001) and more often women (2103/4181, 50.30{\%}) than those who were not eligible (age: mean 43.7, SD 14.6 years; women: 3633/6514, 55.78{\%}). At the point when potential participants were asked to give consent, a further 2278 refused. Those who refused were a little older (mean 40.2, SD 13.9 years) than those who agreed to participate (mean 38.3, SD 12.5 years; t1842=3.2, P<.001). We measured the outcomes after 12 months of the SMS text message intervention. Attrition from the SMS text message intervention was 4.8{\%} (27/563). The patient dropout rate after 12 months was 0.36{\%} (4/1123), as discovered from the register data. In all, 3.12{\%} (35/1123) of the participants withdrew from the trial. However, dropout rates from the patient survey (either by paper or telephone interview) were 52.45{\%} (589/1123) and 27.8{\%} (155/558), respectively. Almost all participants (536/563, 95.2{\%}) tolerated the intervention, but those who discontinued were more often women (21/27, 78{\%}; P=.009). Finally, participants' age (P<.001), gender (P<.001), vocational education (P=.04), and employment status (P<.001) seemed to predict their risk of dropping out from the postal survey. Conclusions: Patient recruitment and engagement in the 12-month follow-up conducted with a postal survey were the most vulnerable phases in the SMS text message-based trial. People with serious mental health problems may need extra support during the recruitment process and in engaging them in SMS text message-based trials to ensure robust enough evidence for mental health care. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6oHcU2SFp) ", issn="1438-8871", doi="10.2196/jmir.6417", url="//www.mybigtv.com/2017/2/e46/", url="https://doi.org/10.2196/jmir.6417", url="http://www.ncbi.nlm.nih.gov/pubmed/28223262" }
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