Validation of a Digital Intervention to Rehabilitate Cognitive Resources

Официальное название

Transcultural and Multidimensional Validation of dIgital Rehabilitation Intervention of COgnitive Resources Domain-Oriented - Work Package 4

Обзор

The goal of this clinical trial is to learn if the use of a digital cognitive rehabilitation system named RICORDO, that is flexible and capable of adapting the rehabilitation pathway according to the needs and capacity of the patients will prove effective for subjects with Subjective Memory Complaint or with Mild Cognitive Impairment or with Mild Dementia. The main questions it aims to answer are: Will the RICORDO rehabilitation treatment, lead to an improvement in the global cognitive level? Will the RICORDO rehabilitation treatment lead to improved activation of participants in managing their own health and healthcare? Researchers will compare the multidomain cognitive rehabilitation strategy of RICORDO digital solution, with a standard paper pencil rehabilitation care (usual care). Participants will undergo a comprehensive neuropsychological evaluation immediately before, immediately after and six months after the completion of the rehabilitation program. Both interventions, the experimental and the usual care, will last 5 weeks, with 3 weekly sessions of 45 minutes each and can be done autonomously by the patient at home.

Вмешательства

• Другое RICORDO
  During the RICORDO intervention, participants will engage in a multidomain cognitive telerehabilitation program using a digital platform (\[http://www.ricordo-dtx.com/\]), which allows for personalized interventions through an adaptive algorithm allowing an increment in task difficulties according to patients' needs. The treatment can be self-administered by the patient at home. The program lasts five weeks, with three treatment sessions per week, each lasting approximately 45 minutes. The acti
• Другое Treatment as Usual (TAU)
  As described above, this type of intervention will consist in a multidomain cognitive rehabilitation treatment to be self administered by the participants at home with pencil paper excercises. Treatment will last 5 weeks, 3 sessions per week, each lasting approximately 45 minutes. The treatment will follow a predefined incremental difficulty structure since no personalization is available.

Первичные конечные точки

• Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in Activation level of Patients measured by Patient Activation Measure 13 (PAM13) [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]

Вторичные конечные точки (11)

• Change in memory in everyday situations measured by Everyday Memory Questionnaire Revised [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in depressive symptoms measured by Beck Depression Inventory II [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in mood measured by Positive and Negative Affect Scale (PANAS) [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in anxiety level measured by State-Trait Anxiety Inventory (STAI- Y state) [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in Language and Executive Functions evaluated by Phonemic/Semantic alternate fluency test [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in visuospatial abilities evaluated by Benson Figure Copy and recall [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT parts A and B) [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L) [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in immediate recall memory measured by the Free and Cued Selective Reminding Test (FCSRT) [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in delayed recall memory measured by the Free and Cued Selective Reminding Test (FCSRT) [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]
• Change in Theory of Mind ability evaluated by Yoni-48 task [Срок оценки: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)]

Критерии участия

Критерии включения

• Montreal Cognitive Assessment (MoCA) score > 17.79;
• Clinical Dementia Rating (CDR) Scale score ≤ 1;
• Education level > 3 years;
• Age ≥ 65 years;
• Informed consent to participate, confirmed by signing the consent form;
• Availability of a caregiver/study partner able to support the participant;
• Stable pharmacological treatment (past 3 months) with acetylcholinesterase inhibitors, if applicable.

Критерии исключения

• Presence of dysmetria or marked auditory/visual or communication disorders preventing the participation to the trial;
• Presence of ongoing rehabilitation program at the time of enrollment or in the 3 months prior to enrollment;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiT — Milan

Публикации

• Spielberger CD, Gorsuch RL, Lushene RE, et al. State-Trait Anxiety Inventory for adults: manual, instrument and scoring guide. Palo Alto: Mind Garden; 1983
• BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available. PMID 13688369
• Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available. PMID 8232972
• Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian. PMID 23614330
• Isernia S, Rossetto F, Shamay-Tsoory S, Marchetti A, Baglio F. Standardization and normative data of the 48-item Yoni short version for the assessment of theory of mind in typical and atypical conditions. Front Aging Neurosci. 2023 Jan 12;14:1048599. doi: 10.3389/fnagi.2022.1048599. eCollection 2022. PMID 36711213
• Possin KL, Laluz VR, Alcantar OZ, Miller BL, Kramer JH. Distinct neuroanatomical substrates and cognitive mechanisms of figure copy performance in Alzheimer's disease and behavioral variant frontotemporal dementia. Neuropsychologia. 2011 Jan;49(1):43-8. doi: 10.1016/j.neuropsychologia.2010.10.026. Epub 2010 Oct 26. PMID 21029744
• Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21. PMID 23963806
• Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. 1996 Aug;17(4):305-9. doi: 10.1007/BF01997792. PMID 8915764

Идентификаторы

NCT: NCT07064226 · MI-RICORDO · FP-1321

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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