{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T06:17:52Z","timestamp":1787897872993,"version":"build-2784847793"},"reference-count":33,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T00:00:00Z","timestamp":1787875200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["72274110"],"award-info":[{"award-number":["72274110"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["72293582"],"award-info":[{"award-number":["72293582"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Digit. Health"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Mild cognitive impairment (MCI) is a clinically important stage at which non-pharmacological interventions may help preserve cognitive function and daily functioning. Existing digital cognitive training programs are often limited by static task progression, declining engagement, and insufficient responsiveness to moment-to-moment cognitive and emotional states.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study protocol describes a single-center, parallel-group, assessor-blinded randomized controlled trial evaluating an adaptive cognitive training intervention delivered by a socially assistive robot and supported by a large language model (LLM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      A total of 126 adults aged 60 years or older with MCI will be randomized 1:1 to either an LLM-supported robot-assisted adaptive cognitive training intervention (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200963) or a matched non-adaptive computerized cognitive training control condition (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200963). Both groups will receive three individually delivered sessions per week for 24 weeks, with each session lasting approximately 45\u201360\u2005min, followed by a 12-week post-intervention follow-up to assess durability. The intervention group will receive multi-domain cognitive training through a socially assistive robot, with the LLM used as a bounded communication module that generates supportive language for controller-selected task adaptation, instruction style, feedback, and motivational support according to prespecified performance and affective indicators. The primary outcome is change in Montreal Cognitive Assessment (MoCA) score from baseline to week 24. Maintenance of cognitive change at week 36 will be analyzed as a secondary exploratory durability outcome. Secondary outcomes include domain-specific cognitive performance, emotional symptoms, motivation, engagement, adherence, usability, acceptance, expectancy and novelty effects, and safety. A nested exploratory imaging-biomarker sub-cohort will undergo resting-state functional magnetic resonance imaging and plasma biomarker assessment to explore changes in functional connectivity and neurobiological markers. Analyses will follow the intention-to-treat principle using mixed-effects models for repeated measures.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The protocol has been approved by the Ethical Committee of the School of Nursing and Rehabilitation, Shandong University (Approval No. 2026-R-072; approved March 10, 2026). Written informed consent will be obtained before enrollment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/www.chictr.org.cn\/historyversionpubEN.html?regno=ChiCTR2600125870<\/jats:ext-link>\n                      , identifier ChiCTR2600125870.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fdgth.2026.1897477","type":"journal-article","created":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T05:33:56Z","timestamp":1787895236000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["An LLM-supported just-in-time adaptive intervention delivered by a socially assistive robot for cognitive training in mild cognitive impairment: study protocol for an assessor-blinded randomized controlled trial"],"prefix":"10.3389","volume":"8","author":[{"given":"Jingzheng","family":"Yan","sequence":"first","affiliation":[{"name":"School of Nursing and Rehabilitation, Shandong University","place":["Jinan, China"]},{"name":"Department of Nursing, Qilu Hospital, Shandong University","place":["Jinan, China"]},{"name":"Nursing Theory & Practice Innovation Research Center, Shandong University","place":["Jinan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yahui","family":"Cheng","sequence":"additional","affiliation":[{"name":"School of Nursing and Rehabilitation, Shandong University","place":["Jinan, China"]},{"name":"Department of Nursing, Qilu Hospital, Shandong University","place":["Jinan, China"]},{"name":"Nursing Theory & Practice Innovation Research Center, Shandong University","place":["Jinan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaning","family":"Wang","sequence":"additional","affiliation":[{"name":"School of Nursing and Rehabilitation, Shandong University","place":["Jinan, China"]},{"name":"Department of Nursing, Qilu Hospital, Shandong University","place":["Jinan, China"]},{"name":"Nursing Theory & Practice Innovation Research Center, Shandong University","place":["Jinan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingjuan","family":"Cao","sequence":"additional","affiliation":[{"name":"School of Nursing and Rehabilitation, Shandong University","place":["Jinan, China"]},{"name":"Department of Nursing, Qilu Hospital, Shandong University","place":["Jinan, China"]},{"name":"Nursing Theory & Practice Innovation Research Center, Shandong University","place":["Jinan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,28]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1212\/CON.0000000000000313","article-title":"Mild cognitive impairment","volume":"22","author":"Petersen","year":"2016","journal-title":"Continuum (Minneap Minn)"},{"key":"B2","doi-asserted-by":"publisher","first-page":"126","DOI":"10.1212\/WNL.0000000000004826","article-title":"Practice guideline update summary: mild cognitive impairment: report of the guideline development, dissemination, and implementation subcommittee of the American academy of neurology","volume":"90","author":"Petersen","year":"2018","journal-title":"Neurology"},{"key":"B3","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1111\/joim.12191","article-title":"Clinical trials and late-stage drug development for Alzheimer disease: an appraisal from 1984 to 2014","volume":"275","author":"Schneider","year":"2014","journal-title":"J Intern Med"},{"key":"B4","doi-asserted-by":"publisher","first-page":"63","DOI":"10.7326\/M17-1531","article-title":"Does cognitive training prevent cognitive decline?: a systematic review","volume":"168","author":"Butler","year":"2018","journal-title":"Ann Intern Med"},{"key":"B5","doi-asserted-by":"publisher","first-page":"CD012279","DOI":"10.1002\/14651858.CD012279.pub2","article-title":"Computerised cognitive training for preventing dementia in people with mild cognitive impairment","volume":"3","author":"Gates","year":"2019","journal-title":"Cochrane Database Syst Rev"},{"key":"B6","doi-asserted-by":"publisher","first-page":"238","DOI":"10.1007\/s11065-022-09537-4","article-title":"Behaviour change techniques in computerized cognitive training for cognitively healthy older adults: a systematic review","volume":"33","author":"Peeters","year":"2023","journal-title":"Neuropsychol Rev"},{"key":"B7","doi-asserted-by":"publisher","first-page":"e40588","DOI":"10.1371\/journal.pone.0040588","article-title":"Computerized cognitive training with older adults: a systematic review","volume":"7","author":"Kueider","year":"2012","journal-title":"PLoS One"},{"key":"B8","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1109\/MRA.2012.2229939","article-title":"Brian 2.1: a socially assistive robot for the elderly and cognitively impaired","volume":"20","author":"McColl","year":"2013","journal-title":"IEEE Robot Autom Mag"},{"key":"B9","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1007\/s11257-022-09333-y","article-title":"Personalized home-care support for the elderly: a field experience with a social robot at home","volume":"33","author":"Di Napoli","year":"2023","journal-title":"User Model User-Adapt Interact"},{"key":"B10","doi-asserted-by":"crossref","first-page":"768","DOI":"10.1109\/ROMAN.2013.6628406","article-title":". Functional requirements and design issues for a socially assistive robot for elderly people with mild cognitive impairments","volume-title":"2013 IEEE RO-MAN.","author":"Bruno","year":"2013"},{"key":"B11","doi-asserted-by":"publisher","first-page":"866","DOI":"10.1001\/jama.2023.14217","article-title":"Creation and adoption of large language models in medicine","volume":"330","author":"Shah","year":"2023","journal-title":"JAMA"},{"key":"B12","doi-asserted-by":"publisher","first-page":"3648","DOI":"10.1016\/j.cell.2025.05.018","article-title":"The generative era of medical AI","volume":"188","author":"Fahrner","year":"2025","journal-title":"Cell"},{"key":"B13","doi-asserted-by":"publisher","first-page":"446","DOI":"10.1007\/s12160-016-9830-8","article-title":"Just-in-time adaptive interventions (JITAIs) in mobile health: key components and design principles for ongoing health behavior support","volume":"52","author":"Nahum-Shani","year":"2018","journal-title":"Ann Behav Med"},{"key":"B14","doi-asserted-by":"publisher","first-page":"m3210","DOI":"10.1136\/bmj.m3210","article-title":"Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension","volume":"370","author":"Cruz Rivera","year":"2020","journal-title":"Br Med J"},{"key":"B15","doi-asserted-by":"publisher","first-page":"e12442","DOI":"10.1002\/trc2.12442","article-title":"Longitudinal associations of apathy and regional tau in mild cognitive impairment and dementia: findings from the Alzheimer\u2019s disease neuroimaging initiative","volume":"10","author":"Premnath","year":"2024","journal-title":"Alzheimers Dement (N Y)"},{"key":"B16","doi-asserted-by":"publisher","first-page":"9","DOI":"10.3389\/fnagi.2020.00009","article-title":"Depression, anxiety, and apathy in mild cognitive impairment: current perspectives","volume":"12","author":"Ma","year":"2020","journal-title":"Front Aging Neurosci"},{"key":"B17","doi-asserted-by":"publisher","first-page":"421","DOI":"10.3233\/JAD-150146","article-title":"The apathy evaluation scale: a comparison of subject, informant, and clinician report in cognitively normal elderly and mild cognitive impairment","volume":"47","author":"Guercio","year":"2015","journal-title":"J Alzheimers Dis"},{"key":"B18","doi-asserted-by":"publisher","first-page":"410","DOI":"10.1111\/jocn.14663","article-title":"Symptoms of apathy and passivity in dementia: a simultaneous concept analysis","volume":"28","author":"Gilmore-Bykovskyi","year":"2019","journal-title":"J Clin Nurs"},{"key":"B19","doi-asserted-by":"publisher","first-page":"1061","DOI":"10.3390\/brainsci13071061","article-title":"A systematic review of pharmacological interventions for apathy in aging neurocognitive disorders","volume":"13","author":"Theleritis","year":"2023","journal-title":"Brain Sci"},{"key":"B20","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1016\/S1474-4422(04)00767-7","article-title":"An active and socially integrated lifestyle in late life might protect against dementia","volume":"3","author":"Fratiglioni","year":"2004","journal-title":"Lancet Neurol"},{"key":"B21","doi-asserted-by":"publisher","first-page":"100912","DOI":"10.1016\/j.arr.2019.100912","article-title":"Cognitive and neural plasticity in old age: a systematic review of evidence from executive functions cognitive training","volume":"53","author":"Nguyen","year":"2019","journal-title":"Ageing Res Rev"},{"key":"B22","doi-asserted-by":"publisher","first-page":"e1001756","DOI":"10.1371\/journal.pmed.1001756","article-title":"Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers","volume":"11","author":"Lampit","year":"2014","journal-title":"PLoS Med"},{"key":"B23","doi-asserted-by":"publisher","first-page":"04069","DOI":"10.7189\/jogh.13.04069","article-title":"Efficacy of multi-domain cognitive function training on cognitive function, working memory, attention, and coordination in older adults with mild cognitive impairment and mild dementia: a one-year prospective randomised controlled trial","volume":"13","author":"Sung","year":"2023","journal-title":"J Glob Health"},{"key":"B24","doi-asserted-by":"publisher","first-page":"1075","DOI":"10.1111\/psyg.13161","article-title":"Exploring transfer effects on memory and its neural mechanisms through a computerized cognitive training in mild cognitive impairment: randomized controlled trial","volume":"24","author":"Kang","year":"2024","journal-title":"Psychogeriatrics"},{"key":"B25","doi-asserted-by":"publisher","first-page":"219","DOI":"10.1080\/15427609.2017.1340050","article-title":"Cognitive performance in adults\u2019 daily lives: is there a lab-life gap?","volume":"14","author":"Bielak","year":"2017","journal-title":"Res Hum Dev"},{"key":"B26","doi-asserted-by":"publisher","first-page":"15875","DOI":"10.3390\/ijerph192315875","article-title":"Ecological effects of VR-based cognitive training on ADL and IADL in MCI and AD patients: a systematic review and meta-analysis","volume":"19","author":"Son","year":"2022","journal-title":"Int J Environ Res Public Health"},{"key":"B27","doi-asserted-by":"publisher","first-page":"1303","DOI":"10.3233\/JAD-160773","article-title":"Alzheimer\u2019s disease neuroimaging initiative. Does functional connectivity provide a marker for cognitive rehabilitation effects in Alzheimer\u2019s disease? An interventional study","volume":"57","author":"Ochmann","year":"2017","journal-title":"J Alzheimers Dis"},{"key":"B28","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1007\/s00429-024-02888-z","article-title":"Advances in the fMRI analysis of the default mode network: a review","volume":"230","author":"Sanz-Morales","year":"2024","journal-title":"Brain Struct Funct"},{"key":"B29","doi-asserted-by":"publisher","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","article-title":"SPIRIT 2013 statement: defining standard protocol items for clinical trials","volume":"158","author":"Chan","year":"2013","journal-title":"Ann Intern Med"},{"key":"B30","doi-asserted-by":"publisher","first-page":"695","DOI":"10.1111\/j.1532-5415.2005.53221.x","article-title":"The Montreal cognitive assessment, MoCA: a brief screening tool for mild cognitive impairment","volume":"53","author":"Nasreddine","year":"2005","journal-title":"J Am Geriatr Soc"},{"key":"B31","doi-asserted-by":"publisher","first-page":"g1687","DOI":"10.1136\/bmj.g1687","article-title":"Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide","volume":"348","author":"Hoffmann","year":"2014","journal-title":"Br Med J"},{"key":"B32","doi-asserted-by":"publisher","first-page":"295","DOI":"10.7326\/0003-4819-148-4-200802190-00008","article-title":"Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration","volume":"148","author":"Boutron","year":"2008","journal-title":"Ann Intern Med"},{"key":"B33","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1186\/s13195-021-00805-8","article-title":"Plasma neurofilament light and phosphorylated tau 181 as biomarkers of Alzheimer\u2019s disease pathology and clinical disease progression","volume":"13","author":"Clark","year":"2021","journal-title":"Alzheimers Res Ther"}],"container-title":["Frontiers in Digital Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2026.1897477\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T05:33:57Z","timestamp":1787895237000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fdgth.2026.1897477\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,28]]},"references-count":33,"alternative-id":["10.3389\/fdgth.2026.1897477"],"URL":"https:\/\/doi.org\/10.3389\/fdgth.2026.1897477","relation":{},"ISSN":["2673-253X"],"issn-type":[{"value":"2673-253X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,28]]},"article-number":"1897477"}}