Division of Psychology, Mayo Clinic, Jacksonville, Florida.
Division of Psychology, Mayo Clinic, Scottsdale, Arizona.
JAMA Netw Open. 2019 May 3;2(5):e193016. doi: 10.1001/jamanetworkopen.2019.3016.
Recommendations to engage in behavioral strategies to combat clinically significant cognitive and behavioral symptoms are routinely given to persons with mild cognitive impairment (MCI). The comparative effectiveness of these behavioral interventions is not well understood.
To compare the incremental effects of combinations of 5 behavioral interventions on outcomes of highest importance to patients with MCI.
DESIGN, SETTING, AND PARTICIPANTS: In this multisite, cluster randomized, multicomponent comparative effectiveness trial, 272 patients from 4 academic medical outpatient centers (Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Scottsdale, Arizona; Mayo Clinic, Jacksonville, Florida; and University of Washington, Seattle) were recruited from September 1, 2014, to August 31, 2016, with last follow-up March 31, 2019. All participants met the National Institute on Aging-Alzheimer's Association criteria for MCI.
The intervention program was modeled on the Mayo Clinic Healthy Action to Benefit Independence and Thinking (HABIT) program, a 50-hour group intervention conducted during 2 weeks, including memory compensation training, computerized cognitive training, yoga, patient and partner support groups, and wellness education. In our study, 1 of 5 interventions was randomly selected to be withheld for each intervention group. Participants and their partners had 1-day booster sessions at 6 and 12 months after intervention.
Quality-of-life measurement of participants with MCI at 12 months was the primary outcome, selected based on the preference rankings of previous program participants. Mood, self-efficacy, and memory-based activities of daily living were also highly ranked.
A total of 272 participants (mean [SD] age, 75 [8] years; 160 [58.8%] male and 112 [41.2%] female) were enrolled in this study, with 56 randomized to the no yoga group, 54 to no computerized cognitive training, 52 to no wellness, 53 to no support, and 57 to no memory support system. The greatest effect size for quality of life was between the no computerized cognitive training and no wellness education groups at 0.34 (95% CI, 0.05-0.64). In secondary analyses, wellness education had a greater effect on mood than computerized cognitive training (effect size, 0.53; 95% CI, 0.21-0.86), and yoga had a greater effect on memory-related activities of daily living than support groups (effect size, 0.43; 95% CI, 0.13-0.72).
These results provide further support for behavioral interventions for persons with MCI. Different outcomes were optimized by different combinations of interventions. These findings provide an initial exploration of the effect of behavioral interventions on patient-advocated outcomes in persons with MCI.
ClinicalTrials.gov identifier: NCT02265757.
建议患有轻度认知障碍 (MCI) 的人采取行为策略来对抗临床显著的认知和行为症状。这些行为干预措施的相对有效性还不太清楚。
比较 5 种行为干预措施组合对 MCI 患者最重要的结局的增量影响。
设计、地点和参与者:这是一项多地点、聚类随机、多成分的比较有效性试验,共有 272 名参与者来自 4 个学术医疗门诊中心(明尼苏达州罗切斯特的梅奥诊所、亚利桑那州斯科茨代尔的梅奥诊所、佛罗里达州杰克逊维尔的梅奥诊所和西雅图的华盛顿大学),他们于 2014 年 9 月 1 日至 2016 年 8 月 31 日招募,最后一次随访是在 2019 年 3 月 31 日。所有参与者均符合美国国家老龄化研究所-阿尔茨海默病协会 (NIA-AA) 对 MCI 的标准。
干预方案以梅奥诊所的健康行动促进独立和思维(HABIT)计划为模型,这是一个为期 2 周的 50 小时小组干预,包括记忆补偿训练、计算机认知训练、瑜伽、患者和伴侣支持小组以及健康教育。在我们的研究中,每个干预组随机选择 5 个干预措施中的 1 个进行保留。参与者及其伴侣在干预后 6 个月和 12 个月进行为期 1 天的强化课程。
MCI 患者在 12 个月时的生活质量测量是主要结局,这是基于先前项目参与者的偏好排名选择的。情绪、自我效能和基于记忆的日常生活活动也是高度优先考虑的。
共有 272 名参与者(平均[SD]年龄为 75[8]岁;160[58.8%]为男性,112[41.2%]为女性)参加了这项研究,其中 56 名被随机分配到无瑜伽组,54 名被分配到无计算机认知训练组,52 名被分配到无健康教育组,53 名被分配到无支持组,57 名被分配到无记忆支持系统组。生活质量的最大效应量是在无计算机认知训练组和无健康教育培训组之间,为 0.34(95%CI,0.05-0.64)。在二次分析中,健康教育培训对情绪的影响大于计算机认知训练(效应量为 0.53;95%CI,0.21-0.86),瑜伽对与记忆相关的日常生活活动的影响大于支持小组(效应量为 0.43;95%CI,0.13-0.72)。
这些结果进一步支持了针对 MCI 患者的行为干预措施。不同的组合干预措施优化了不同的结果。这些发现初步探索了行为干预对 MCI 患者患者倡导的结局的影响。
ClinicalTrials.gov 标识符:NCT02265757。