Web-enabled social interaction to delay cognitive decline among seniors with MCI: Phase I
Web-enabled social interaction to delay cognitive decline among seniors with MCI: Phase I
批准号:
9930344
负责人:
HIROKO Hayama DODGE
金额:
$40.23万
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-07-01 至 2022-03-31
关键词:
AdherenceAdvanced DevelopmentAgeAged, 80 and overAgingAlgorithmsAlzheimer&aposs DiseaseAmygdaloid structureAreaAtrophicAttentionBrainBrain imagingCharacteristicsCognitionCognitiveCommunicationCommunitiesControl GroupsCross-Sectional StudiesDementiaDeveloped CountriesDeveloping CountriesDiffusion Magnetic Resonance ImagingElderlyFaceFeasibility StudiesFillerFunctional Magnetic Resonance ImagingFundingFutureHealthHippocampus (Brain)Home environmentImpaired cognitionIncidenceInternetInterventionInterviewerLanguageLeadLocationLow incomeMagnetic Resonance ImagingMeals on WheelsMemoryMichiganMonitorMoodsOregonOutcomeOutcome MeasureParticipantPersonal ComputersPersonal SatisfactionPersonsPharmaceutical PreparationsPhasePilot ProjectsPopulationPrefrontal CortexPrevalencePreventionPrevention approachProtocols documentationPublic HealthRandomizedResearch Project GrantsRestRisk FactorsSample SizeSamplingSocial InteractionSocial NetworkSocial isolationSpeechSpeedStructureTechnologyTemporal SulcusTimeTrainingTreatment EfficacyUnited States National Institutes of HealthWell in selfagedaging populationbasebehavioral clinical trialcognitive functioncost effectiveefficacy studyefficacy trialepidemiology studyethnic minority populationexecutive functiongroup interventionhigh riskimaging studyimprovedinclusion criteriainstrumental activity of daily livingintervention costintervention effectmild cognitive impairmentmorphometryphase 1 studyphase I trialprimary outcomerecruitsecondary outcomesocialtherapy developmenttouchscreenuser-friendlyweb-enabledweek trial
中文摘要
更大的社交网络和/或更频繁的社交互动与AD的发病率较低相关,
人口水平;增加社会互动可能是改善认知能力的有希望的干预措施。
老年人的幸福。在我们之前的随机对照行为临床试验中,我们开发了一种
基于对话的社交互动认知刺激协议,由经过培训的面试官通过
个人电脑、网络摄像头和带有触摸屏的用户友好交互式互联网界面
(ClinicalTrials.gov:NCT 01571427)。每天进行30分钟的面对面交流,
干预组试用期为1周。尽管样本量较小,但该初步研究(2014年6月30日完成)
在老年人群(平均年龄80岁)中证明了可行性、高依从性和
与对照组相比,干预组的语言执行功能。
基于这些积极的结果,我们提出了一个I期试验,以推进这一发展。
干预主要目的(目的1)是检查我们的干预对认知功能的有效性,
目标群体-80岁及以上的MCI患者和社交机会有限的人。我们
主要结果是语言、注意力、执行力和记忆领域的认知功能
功能,次要结局是目标IADL功能(药物使用和依从性)和总体
情绪健康(情绪,自我评价的健康)。个人特定的社会互动水平(即,平均
试验外的谈话)将在分析中进行监测和控制。探索目标2是
检查干预是否会导致言语和语言特征随时间的变化,
根据我们在这一领域有希望的横截面发现,分析记录的日常会话。
探索性目的3是通过评估试验前后的变化来检查疗效的潜在机制
额叶皮层、背外侧前额叶皮层、杏仁核和其他ROI使用MRI和无偏全脑
评估(基于体素的形态测量),以及使用扩散张量的结构和功能连接
DTI和静息状态功能MRI(R-fMRI)。共招募144名MCI受试者,
在俄勒冈州的波特兰和密歇根州的底特律进行随机化,与车轮上的膳食和地区机构合作
在这两个地点的老龄化(AAA),创造了一个大的抽样框架,那些低收入和种族
少数群体一半的参与者将被随机选择并被邀请参加大脑成像研究。
通过通信技术增加日常社会联系可以提供一个具有成本效益的家庭-
基于预防,可以减缓认知能力下降,延迟AD的发作,从而减少整体
痴呆症的社会负担。在大多数发达国家,最年长的老年人是人口中增长最快的部分。
在这些国家中,老年痴呆症和社会隔离的风险最高(不利健康的风险因素
成果)。这一人群迫切需要方便用户的可持续预防方法。
英文摘要
Larger social networks and/or more frequent social interactions are associated with lower incidence of AD, at
the population level; increasing social interaction may be a promising intervention for improving the cognitive
well-being of older adults. In our previous randomized controlled behavioral clinical trial, we developed a
conversation-based social interaction cognitive stimulation protocol delivered by trained interviewers through
personal computers, webcams, and a user-friendly interactive Internet interface with a touch screen
(ClinicalTrials.gov:NCT01571427). Daily 30-minute face-to-face communications were conducted over a 6-
week trial period in the intervention group. Despite a small sample size, this pilot study (completed 6/30/2014)
demonstrated feasibility, high adherence in an elderly population (mean age 80 years) and efficacy in
language-based executive functions among the intervention group in comparison to the control group.
Based upon these positive results, we propose a Phase I trial to advance development of this
intervention. Primary aim (Aim 1) is to examine the efficacy of our intervention on cognitive functions among
the target group - those aged 80 and older with MCI and limited opportunities of social interactions. Our
primary outcomes are cognitive functions in the domains of language, attention, executive and memory
functions, and secondary outcomes are a targeted IADL function (medication use and adherence) and overall
emotional well-being (mood, self-rated health). Person-specific levels of social interactions (i.e., average
conversation outside of the trial) will be monitored and controlled in the analyses. Exploratory Aim 2 is to
examine whether the intervention could lead to changes in speech and language characteristics over time by
analyzing recorded daily conversational sessions, based on our promising cross-sectional findings in this area.
Exploratory Aim 3 is to examine underlying mechanisms of efficacy by assessing pre- and post- trial changes
inhippocampal, dorsolateral prefrontal cortex, amygdala and other ROIsusing MRI and unbiased whole brain
assessment (voxel-based morphometry), and structural and functional connectivity using diffusion tensor
imaging (DTI) and resting state functional MRI (R-fMRI). A total of 144 MCI subjects will be recruited and
randomized at Portland, Oregon, and Detroit, Michigan, collaborating with Meals on Wheels and Area Agency
on Aging (AAA) at both locations, creating a large sampling frame of those with low income and from ethnic
minorities. Half of the participants will be randomly selected and invited to participate in the brain imaging study.
Increasing daily social contact through communication technologies could offer a cost-effective home-
based prevention that could slow cognitive decline, delay the onset of AD, and thereby reduce the overall
societal burden of dementia. The oldest old is the fastest growing segment of the population in most developed
countries, and face the highest risk of developing dementia and social isolation (risk factors of adverse health
outcomes). User-friendly sustainable prevention approaches are urgently needed in this population.
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