PDF(Pubmed)
Abstract：
BACKGROUND: Developing evidence for the use of psychosocial interventions for people with dementia is a research priority. This pilot study aimed to provide variability estimates for a set of outcome measures that would inform the development of a more extensive controlled study. The larger study will seek to explore the effect of attending a lifelong learning intervention for people with dementia compared to receiving treatment as usual. This pilot and feasibility stage also analysed how data collectors and researchers evaluated the use of the outcome measures in a sample of people with mild to moderate dementia.
METHODS: Before initiating the pilot study, a participant consultation was conducted with people with dementia, who attend a lifelong learning service known as a dementia school, and their teachers. From this consultation, the research outcomes identified were the mini-mental state examination (MMSE), Quality-of-Life Alzheimer\'s Disease (QoL-AD), General Self-Efficacy Scale (GSE), Rosenberg self-esteem scale, and the Friendship scale. The following study was divided into two steps. In step 1, participants were people with dementia attending a dementia school (intervention group) or usual services (control group). The participants were tested at baseline and at a 6-month follow-up. Data were collected between November 2018 and July 2019. In step 2, feasibility and acceptability issues with the recruitment of participants, data collection process, and outcome measures, identified in step 1, were evaluated through a data collector focus group.
RESULTS: Fifty-five people with dementia were included in the analysis. Step 1 provided estimates of changes from baseline to follow-up, and ancillary standard deviations were supplied for all outcome measures. Step 2 provided reflections on the feasibility and acceptability of the intervention, data collection, and outcome measures. This included views on how people with dementia experience participating in a test situation.
CONCLUSIONS: This study provided estimates of change and variability in the outcome measures. Additionally, issues regarding data collection were identified and should be addressed in future studies. The project demonstrated how to support people with dementia to participate in research that is meaningful to them.
BACKGROUND: According to national legislation, registration with a database of clinical studies was optional, as the study evaluated existing activities rather than a clinical intervention.
METHODS: Before initiating the pilot study, a participant consultation was conducted with people with dementia, who attend a lifelong learning service known as a dementia school, and their teachers. From this consultation, the research outcomes identified were the mini-mental state examination (MMSE), Quality-of-Life Alzheimer\'s Disease (QoL-AD), General Self-Efficacy Scale (GSE), Rosenberg self-esteem scale, and the Friendship scale. The following study was divided into two steps. In step 1, participants were people with dementia attending a dementia school (intervention group) or usual services (control group). The participants were tested at baseline and at a 6-month follow-up. Data were collected between November 2018 and July 2019. In step 2, feasibility and acceptability issues with the recruitment of participants, data collection process, and outcome measures, identified in step 1, were evaluated through a data collector focus group.
RESULTS: Fifty-five people with dementia were included in the analysis. Step 1 provided estimates of changes from baseline to follow-up, and ancillary standard deviations were supplied for all outcome measures. Step 2 provided reflections on the feasibility and acceptability of the intervention, data collection, and outcome measures. This included views on how people with dementia experience participating in a test situation.
CONCLUSIONS: This study provided estimates of change and variability in the outcome measures. Additionally, issues regarding data collection were identified and should be addressed in future studies. The project demonstrated how to support people with dementia to participate in research that is meaningful to them.
BACKGROUND: According to national legislation, registration with a database of clinical studies was optional, as the study evaluated existing activities rather than a clinical intervention.
摘要：
背景：为痴呆症患者使用心理社会干预措施提供证据是研究的重点。这项试点研究旨在为一组结果测量提供变异性估计，这将为更广泛的对照研究的发展提供信息。这项更大的研究将寻求探索与照常接受治疗相比，对痴呆症患者进行终身学习干预的效果。这个试点和可行性阶段还分析了数据收集者和研究人员如何评估轻度至中度痴呆症患者样本中结果指标的使用。
方法：在开始试点研究之前，与痴呆症患者进行了参与者咨询，他们参加了一个被称为痴呆症学校的终身学习服务，和他们的老师。从这次协商中，确定的研究结果是小型精神状态检查(MMSE)，生活质量阿尔茨海默病（QoL-AD），一般自我效能感量表（GSE），罗森伯格自尊量表，友谊的规模。下面的研究分为两个步骤。在步骤1中，参与者是参加痴呆症学校（干预组）或常规服务（对照组）的痴呆症患者。参与者在基线和6个月随访时进行了测试。数据收集时间为2018年11月至2019年7月。在步骤2中，招募参与者的可行性和可接受性问题，数据收集过程，和结果衡量标准，在步骤1中确定的数据通过数据收集器焦点组进行评估.
结果：55名痴呆症患者被纳入分析。步骤1提供了从基线到后续行动的变化估计，并为所有结果测量提供辅助标准偏差。步骤2对干预的可行性和可接受性进行了思考，数据收集，和结果措施。这包括对痴呆症患者如何参与测试情况的看法。
结论：本研究提供了对结果测量的变化和变异性的估计。此外,确定了有关数据收集的问题，应在未来的研究中解决。该项目展示了如何支持痴呆症患者参与对他们有意义的研究。
背景：根据国家立法，注册临床研究数据库是可选的，因为该研究评估了现有的活动，而不是临床干预。
方法：在开始试点研究之前，与痴呆症患者进行了参与者咨询，他们参加了一个被称为痴呆症学校的终身学习服务，和他们的老师。从这次协商中，确定的研究结果是小型精神状态检查(MMSE)，生活质量阿尔茨海默病（QoL-AD），一般自我效能感量表（GSE），罗森伯格自尊量表，友谊的规模。下面的研究分为两个步骤。在步骤1中，参与者是参加痴呆症学校（干预组）或常规服务（对照组）的痴呆症患者。参与者在基线和6个月随访时进行了测试。数据收集时间为2018年11月至2019年7月。在步骤2中，招募参与者的可行性和可接受性问题，数据收集过程，和结果衡量标准，在步骤1中确定的数据通过数据收集器焦点组进行评估.
结果：55名痴呆症患者被纳入分析。步骤1提供了从基线到后续行动的变化估计，并为所有结果测量提供辅助标准偏差。步骤2对干预的可行性和可接受性进行了思考，数据收集，和结果措施。这包括对痴呆症患者如何参与测试情况的看法。
结论：本研究提供了对结果测量的变化和变异性的估计。此外,确定了有关数据收集的问题，应在未来的研究中解决。该项目展示了如何支持痴呆症患者参与对他们有意义的研究。
背景：根据国家立法，注册临床研究数据库是可选的，因为该研究评估了现有的活动，而不是临床干预。
