Baron Justine, Hirani Shashivadan, Newman Stanton
1 Institute of Cardiovascular Science, University College London , London, United Kingdom .
2 Centre for Health Services Research, School of Health Sciences, City University London , London, United Kingdom .
Telemed J E Health. 2016 May;22(5):400-9. doi: 10.1089/tmj.2015.0095. Epub 2015 Nov 5.
Mobile telehealth (MTH) evaluations in diabetes have been conducted, but few report details and issues related to recruitment, implementation (intervention delivery), fidelity, and context. These have important implications on the interpretation of the findings and effectiveness of the intervention. This article reports these data from an MTH study and describes the challenges experienced in running an intervention such as this in an active clinical environment.
We conducted a mixed-methods MTH study that included a 9-month randomized controlled trial in people with poorly controlled diabetes. Detailed recruitment data were recorded during the study. Data on contacts between MTH participants and the MTH team were collected and used to report on intervention delivery and fidelity. Meeting and field notes, as well as communications between research team members during the study, were used to report on the contextual factors that affected recruitment, implementation, and fidelity.
The recruited sample size represented 6% of the total clinic population (n = 1,360) and 10.7% of the number of potentially eligible people at the clinic (n = 802) identified at the beginning of the study. Contextual factors related to patients, healthcare providers, the institution, or the recruitment protocol contributed to influence access to study participants and the number of participants randomized (n = 81). Technical and device-related aspects of the MTH intervention were delivered successfully, but the expected education and clinical feedback by the MTH nurse were not delivered according to the protocol. Although 92.5% of introductory calls were made by the MTH nurses, only 13.3% of expected educational calls were performed. Changes to the MTH nursing staff affected intervention participants differently and contributed to the low fidelity of intervention delivery.
The current article presents data on the influence of contextual factors on the conduct of this MTH study and underlines the need for these processes to be assessed and reported adequately in future MTH research.
针对糖尿病的移动远程医疗（MTH）评估已经开展，但很少有研究报告与招募、实施（干预交付）、保真度和背景相关的细节及问题。这些对研究结果的解读和干预的有效性具有重要影响。本文报告了一项MTH研究中的这些数据，并描述了在活跃的临床环境中开展此类干预所遇到的挑战。
我们开展了一项混合方法的MTH研究，其中包括一项针对糖尿病控制不佳患者的为期9个月的随机对照试验。研究期间记录了详细的招募数据。收集了MTH参与者与MTH团队之间的联系数据，并用于报告干预交付和保真度情况。会议记录、实地笔记以及研究期间研究团队成员之间的通信，用于报告影响招募、实施和保真度的背景因素。
招募的样本量占诊所总人数（n = 1360）的6%，占研究开始时诊所潜在合格人数（n = 802）的10.7%。与患者、医疗保健提供者、机构或招募方案相关的背景因素影响了研究参与者的纳入以及随机分组的参与者数量（n = 81）。MTH干预的技术和设备相关方面成功交付，但MTH护士预期的教育和临床反馈未按方案提供。尽管92.5%的介绍性电话由MTH护士拨打，但仅完成了13.3%的预期教育电话。MTH护理人员的变动对干预参与者产生了不同影响，并导致干预交付的保真度较低。
本文呈现了背景因素对该MTH研究实施影响的数据，并强调在未来的MTH研究中需要对这些过程进行充分评估和报告。
