评估 FindMyApps：一项基于平板电脑的干预措施的有效性和成本效益的随机对照试验方案，该措施旨在改善轻度痴呆的社区居住者的自我管理和社会参与能力，与常规使用平板电脑进行比较。

Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use.

机构信息

Department of Psychiatry, Amsterdam University Medical Centers, location VUmc, Amsterdam, Netherlands.

Saxion University of Applied Sciences, Deventer, Netherlands.

出版信息

BMC Geriatr. 2021 Feb 24;21(1):138. doi: 10.1186/s12877-021-02038-8.

DOI:10.1186/s12877-021-02038-8

PMID:33627069

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7903400/

Abstract

BACKGROUND

For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness.

METHODS

A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm - tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm - tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken.

DISCUSSION

Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field.

TRIAL REGISTRATION NUMBER

Netherlands Trial Register: NL8157 ; registered 15th November 2019.

摘要

背景

随着痴呆症患者人数的增加，需要经济有效的以社区为基础的干预措施来支持心理社会护理。FindMyApps 干预措施是为痴呆症患者及其照顾者开发的，旨在帮助他们使用平板电脑来促进自我管理和参与有意义的社会活动。已经进行了一项可行性研究和探索性试点试验来评估 FindMyApps。这项确证性试验进一步评估了干预措施的有效性，并首次评估了成本效益。

方法

将开展一项随机对照非盲单中心双臂优效性试验。纳入社区居住的轻度认知障碍（MCI）患者，或简易精神状态检查（MMSE）评分＞17 且＜26 的痴呆症患者，或全球衰退量表 3 或 4 级，且有非专业照顾者并有无线互联网连接的患者及其照顾者。总共将纳入 150 对患者-照顾者对，随机分配接受常规护理（对照组-平板电脑；n=75 对）或常规护理和 FindMyApps 干预（实验组-平板电脑和 FindMyApps；n=75 对）。主要结局是：对于痴呆症患者，自我管理和社会参与；对于照顾者，胜任感。除了主要效果分析外，还将进行成本效益分析。根据 MRC 对复杂干预措施评估的指南，还将进行过程评估。

讨论

预计试验结果将于 2023 年公布，并将提交国际同行评议的科学期刊发表，除了会议演讲和通过欧盟玛丽·斯克沃多夫斯卡-居里区分 ITN 网络报告。通过提供 FindMyApps 干预措施有效性和成本效益的证据或反对证据，试验结果将影响 FindMyApps 在全国的实施。我们希望试验结果将进一步激发痴呆症中技术和心理社会护理交叉领域的研究和发展。我们希望进一步证明随机对照试验是评估新的数字技术的有价值且可行的手段，以激发该不断发展领域的进一步高质量研究。