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首页> 外文期刊>JMIR Research Protocols >Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial
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Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial

机译：2型糖尿病患者的低强度自我管理干预，使用基于手机的糖尿病日记，有或没有健康咨询和动机访谈：一项随机对照试验的方案

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Background The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project—REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. Objective The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. Methods The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients’ registrations on the application are recorded continuously and are sent securely to a server. Results The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. Conclusions The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients’ health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management. Trial Registration Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).
机译：背景技术本研究方案旨在涵盖欧盟合作项目的挪威部分，即欧洲REgioNs共同致力于健康（更新健康）。自我管理支持是2型糖尿病（T2D）患者获得代谢控制和积极的生活方式改变的重要护理要素。带有或不带有健康咨询的远程医疗（TM）可能会成为自我管理的重要技术帮助，并可能提供以用户为中心的护理模型。尽管有许多关于TM的早期研究，但在有关TM干预效果的研究结果中仍缺乏共识。目的更新健康的目的是通过共同的评估来大规模验证和评估创新的TM工具，从而使决策者更容易选择最有效和最具成本效益的技术干预措施。挪威的一项先导研究评估了将带有糖尿病日记应用程序的手机与健康咨询干预措施一起使用是否会在预期结果方面产生益处，如血红蛋白A1c水平，与健康相关的生活质量，行为改变和成本效益。方法：本研究采用混合方法设计，包括三组前瞻性随机对照试验和定性访谈，并在基线，4个月后和1年后三个时间点收集研究数据。患者在应用程序上的注册会被连续记录，并安全地发送到服务器。结果纳入患者始于2011年3月，其中包括计划的样本量的100％（N = 151）。到目前为止，所有参与者中有26/151名患者（17.2％）失去随访，而11/151名患者（7.3％）仍在试验中。研究方案的结果将于2014年提出。结论该试验的主要目标是调查有无健康咨询的电子糖尿病日记应用的效果，并确定健康咨询对继续使用该应用是否重要以及患者的健康能力和可接受性。需要在这一领域进行研究，因为很少有研究调查过这种自我管理程度的长期干预中使用的应用程序的有效性。试验注册Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756（由WebCite存档，网址为http：//www.webcitation/6BTyuRMpH）。

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