Ribu Lis, Holmen Heidi, Torbjørnsen Astrid, Wahl Astrid Klopstad, Grøttland Astrid, Småstuen Milada Cvancarova, Elind Elisabeth, Bergmo Trine Strand, Breivik Elin, Arsand Eirik
Department of Nursing, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
JMIR Res Protoc. 2013 Aug 26;2(2):e34. doi: 10.2196/resprot.2768.
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.
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.
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.
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.
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.
Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).
本研究方案旨在涵盖欧盟合作项目“欧洲地区携手促进健康（RENEWING HEALTH）”的挪威部分。自我管理支持是2型糖尿病（T2D）患者护理的重要组成部分，有助于实现代谢控制和积极的生活方式改变。有无健康咨询的远程医疗（TM）可能成为自我管理的重要技术辅助手段，并可能提供以用户为中心的护理模式。尽管此前有许多关于远程医疗的研究，但关于远程医疗干预效果的研究结果仍缺乏共识。
“RENEWING HEALTH”的目的是通过共同评估大规模验证和评估创新的远程医疗工具，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。挪威的试点研究评估引入一款带有糖尿病日记应用程序的手机以及健康咨询干预措施是否能在糖化血红蛋白水平、健康相关生活质量、行为改变和成本效益等预期结果方面产生益处。
本研究采用混合方法设计，包括一项三臂前瞻性随机对照试验以及在三个时间点（基线、4个月后和1年后）收集研究数据的定性访谈。患者在应用程序上的注册信息会持续记录并安全发送到服务器。
患者纳入工作于2011年3月开始，计划样本量的100%已纳入（N = 151）。到目前为止，所有参与者中有26/151名患者（17.2%）失访，11/151名患者（7.3%）仍在试验中。研究方案的结果将于2014年公布。
该试验的关键目标是研究有无健康咨询的电子糖尿病日记应用程序的效果，并确定健康咨询对于应用程序的持续使用以及患者的健康能力和可接受性是否重要。这一领域需要开展研究，因为很少有研究以这种自我管理程度调查应用程序在长期干预中的有效性。
Clinicaltrials.gov NCT01315756；http://clinicaltrials.gov/ct2/show/NCT01315756（由WebCite存档于http://www.webcitation/6BTyuRMpH）
