Anderberg Peter, Barnestein-Fonseca Pilar, Guzman-Parra Jose, Garolera Maite, Quintana María, Mayoral-Cleries Fermin, Lemmens Evi, Sanmartin Berglund Johan
Department of Health, Blekinge Institute of Technology, Karlskrona, Sweden.
Research Unit, La Unidad de Gestión Clínica de Mental Health, Instituto de Investigación Biomédica de Málaga, Hospital Regional Universitario Málaga, Malaga, Spain.
JMIR Res Protoc. 2019 Jun 21;8(6):e13711. doi: 10.2196/13711.
Many countries are witnessing a trend of growth in the number and proportion of older adults within the total population. In Europe, population aging has had and will continue to have major social and economic consequences. This is a fundamentally positive development where the added life span is of great benefit for both the individual and the society. Yet, the risk for the individual to contract noncommunicable diseases and disability increases with age. This may adversely affect the individual's ability to live his or her life in the way that is desired. Cognitive conditions constitute a group of chronic diseases that predominantly affects older people. Recent technology advancements can help support the day-to-day living activities at home for people with cognitive impairments.
A digital platform (Support Monitoring and Reminder for Mild Dementia; SMART4MD) is created to improve or maintain the quality of life for people with mild cognitive impairment (PwMCI) and their carers. The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress. In the trial, we will include participants with a diagnosed neurocognitive disorder as well as persons with an undiagnosed subjective memory problem and cognitive impairment, that is, 20 to 28 points on the Mini-Mental State Examination.
A pragmatic, multicenter RCT is being conducted in Spain, Sweden, and Belgium. The targets for recruitment are 1200 dyads-split into an intervention group and a control group that are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD app. Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities, and sharing health information.
Inclusion of participants started in December 2017, and recruitment is expected to end in February 2019. Furthermore, there will be 3 follow-up visits at 6, 12, and 18 months after the baseline visit.
This RCT is expected to offer benefits at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered information and communication technology solution for this group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group's relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people and this full scale RCT can hopefully serve as a model for further studies in this field.
ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13711.
许多国家正在经历老年人口数量及其在总人口中所占比例增长的趋势。在欧洲，人口老龄化已经并将继续产生重大的社会和经济影响。从根本上来说，这是一个积极的发展趋势，因为延长的寿命对个人和社会都大有裨益。然而，个体患非传染性疾病和残疾的风险会随着年龄的增长而增加。这可能会对个体按自己期望的方式生活的能力产生不利影响。认知疾病是一类主要影响老年人的慢性疾病。最近的技术进步有助于支持认知障碍患者在家中的日常生活活动。
创建一个数字平台（轻度痴呆支持监测与提醒平台；SMART4MD），以改善或维持轻度认知障碍患者（PwMCI）及其照料者的生活质量。该平台将在日常生活中提供提醒、信息和记忆支持，旨在使生活有条理并减轻压力。在试验中，我们将纳入已被诊断患有神经认知障碍的参与者以及存在未被诊断出的主观记忆问题和认知障碍的人，即简易精神状态检查表得分在20至28分之间的人。
在西班牙、瑞典和比利时进行一项务实的多中心随机对照试验。招募目标是1200对受试者，分为干预组和接受常规护理的对照组。干预组参与者将获得一台装有SMART4MD应用程序的具备数据功能的平板电脑。其核心功能旨在供在家中日常使用，基于提醒、认知支持活动以及共享健康信息。
参与者纳入工作于2017年12月开始，预计招募工作将于2019年2月结束。此外，在基线访视后的6个月、12个月和18个月将进行3次随访。
预计这项随机对照试验将在多个层面带来益处，包括深入了解为该群体引入整体多层信息通信技术解决方案的可能性。SMART4MD是在PwMCI、他们的非正式照料者和临床医生的结构化参与过程中开发的。采用SMART4MD面临着该年龄组相对不熟悉数字设备和服务的挑战。然而，这一挑战也可能成为开发适合面临数字排斥风险群体的数字设备的契机。这项研究回应了更广泛的对开发老年人可获取且负担得起的数字设备的呼吁，并且这项全面的随机对照试验有望成为该领域进一步研究的典范。
ClinicalTrials.gov NCT03325699；https://clinicaltrials.gov/ct2/show/NCT03325699。
国际注册报告识别码（IRRID）：DERR1-10.2196/13711。
