Dam Alieske E H, de Vugt Marjolein E, van Boxtel Martin P J, Verhey Frans R J
Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience/Alzheimer Centre Limburg, Dr. Tanslaan 12 (level 3 | room 3G3.058), P.O. Box 616, 6200, MD, Maastricht, The Netherlands.
Trials. 2017 Aug 29;18(1):395. doi: 10.1186/s13063-017-2097-y.
Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled "Inlife" was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics.
A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T) and at 8-week (T), 16-week (T) and 42-week follow up (T). The 16-week follow-up assessment (T) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention.
Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care.
Dutch trial register, NTR6131 . Registered on 20 October 2016.
痴呆症患者（PwD）的照料者面临负担、孤独感和社会隔离。先前的研究表明在线电子健康干预具有显著效果。使用社交媒体可能有助于为痴呆症照料者网络提供支持。通过迭代逐步的方法，开发了一种名为“Inlife”的社会支持工具。本文描述了一项评估Inlife效果及其过程特征的研究设计。
将对122名痴呆症患者的照料者进行一项混合方法的随机对照试验。参与者将被分配到Inlife社会支持干预组或等待名单对照组。16周后，对照组将获得使用Inlife环境的权限。数据将在基线（T0）、8周（T1）、16周（T2）和42周随访（T3）时收集。16周的随访评估（T2）是评估主要和次要结局结果的主要终点，通过自我报告问卷进行测量。主要结局包括照料者能力感和感知到的社会支持。次要结局包括获得的支持、孤独感、心理问题（如焦虑、压力）和生活质量。将进行包括半结构化访谈在内的过程评估，以检验干预的内部和外部有效性。
采用混合方法设计，我们的研究将为Inlife干预的可用性、有效性以及与实施相关的因素提供有价值的见解。我们的研究结果将表明Inlife在未来常规痴呆症护理中是否可能成为一种有价值的社会支持资源。
荷兰试验注册中心，NTR6131。于2016年10月20日注册。
