Validation of a Digital Intervention to Rehabilitate Cognitive Resources

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.

Interventions

• RICORDO · OTHER

  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 active control group (TAU) will undergo the same type of treatment with the following differences: the digital platform will not be used, as the treatment will consist solely of paper-and-pencil exercises; and there will be no personalization of the exercises, since automatic adaptation is not possible.

• Treatment as Usual (TAU) · OTHER

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

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

Exclusion criteria:

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

Sites (1)

• IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiTeR), Milan, Italy · RECRUITING