Transcultural and Multidimensional Validation of dIgital Rehabilitation Intervention of COgnitive Resources Domain-Oriented - Work Package 4
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
RICORDO
Participants will carry out telerehabilitation using a digital platform [http://www.ricordo-dtx.com/\], at home, autonomously.
Intervention: RICORDO (Other)
Treatment as Usual (TAU)
Participants will follow a traditional paper-and-pencil rehabilitation protocol at home, autonomously.
Intervention: Treatment as Usual (TAU) (Other)
Outcomes
Primary Outcomes
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA
Time Frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
MoCA is a screening test for cognitive deficits. It measures the global cognitive functioning and includes several tasks involving different domains: visuospatial/executive function, language, selective and sustained attention, abstraction, memory and orientation. Score ranges from 0 to 30 with higher scores indicating better general cognitive performance.
Change in Activation level of Patients measured by Patient Activation Measure 13 (PAM13)
Time Frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
The Patient Activation Measure (PAM-13) is a 13-item instrument designed to evaluate an individual's knowledge, skills, and confidence in effectively managing their health and healthcare. The total PAM-13 score ranges from 0 to 100, with higher scores indicating greater levels of activation and more favorable outcomes. Individuals classified in the lowest activation level typically lack awareness of their role in managing their health, demonstrate limited health-related knowledge, and possess underdeveloped self-management abilities. In contrast, those in the highest activation level exhibit proactive health behaviors, possess well-established self-management competencies, and demonstrate resilience in response to stress or health-related changes.
Secondary Outcomes
- Change in memory in everyday situations measured by Everyday Memory Questionnaire Revised(Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up))
- Change in depressive symptoms measured by Beck Depression Inventory II(Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up))
- Change in mood measured by Positive and Negative Affect Scale (PANAS)(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)(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(Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up))
- Change in visuospatial abilities evaluated by Benson Figure Copy and recall(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)(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)(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)(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)(Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up))
- Change in Theory of Mind ability evaluated by Yoni-48 task(Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up))