Validation of a Digital Intervention to Rehabilitate Cognitive Resources
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Montreal Cognitive Assessment (MoCA) score > 17.79;
Clinical Dementia Rating (CDR) Scale score ≤ 1;
Education level > 3 years;
Age ≥ 65 years;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
RICORDO
Other interventionDuring 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 interventionAs 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: RICORDOExperimental treatment 1 intervention
Group B: Treatment as Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA
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.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)2
Change in Activation level of Patients measured by Patient Activation Measure 13 (PAM13)
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.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)Secondary outcomes
1
Change in memory in everyday situations measured by Everyday Memory Questionnaire Revised
The Everyday Memory Questionnaire (EMQ) is a self-report instrument designed to assess subjective experiences of memory failure in daily life. The revised version comprises 13 items, each describing a specific memory-related situation. Respondents rate the frequency with which they experience each situation using a 5-point Likert scale. The total score is calculated as the sum of all item responses and ranges from 0 to 52, with higher scores indicating a greater frequency of everyday memory lapses.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)2
Change in depressive symptoms measured by Beck Depression Inventory II
The Beck Depression Inventory II is a self report questionnaire to evaluate the depression level. It consists of 21 questions, each scored on a 4-point scale, with a total score ranging from 0 to 63. The total score is calculated by summing the responses to all 21 questions. HIgher scores indicate more severe deflection of mood tone. The BDI-II can be used to assess the effectiveness of treatment interventions.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)3
Change in mood measured by Positive and Negative Affect Scale (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a self-administered questionnaire designed to assess affective states. It consists of two distinct subscales that measure positive affect (PA) and negative affect (NA), respectively. Each subscale comprises ten descriptive adjectives, with participants rating the extent to which they have experienced each emotion on a 5-point Likert scale, ranging from 1 (very slightly or not at all) to 5 (extremely). The overall PANAS score is calculated by summing the ratings for the items within each subscale, yielding separate PA and NA scores. Score ranges from 10 to 50. Higher scores on each subscale reflect greater intensity of the corresponding affect. In scoring, values from the positive affect items contribute to the PA score, while values from the negative affect items contribute to the NA score.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)4
Change in anxiety level measured by State-Trait Anxiety Inventory (STAI- Y state)
The STAI-Y is a frequeltly used self-reported questionnaire to measure state anxiety (20 items). Each item is rated on a 4-point scale (from "Almost Never" to "Almost Always"). STAI is scored by summing ratings for each item (range 0-80). Higher scores indicate greater anxiety.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)Other outcomes
1
Changes in Fractional Anisotropy (FA) and Mean Diffusivity (MD) as detected by Diffusion Weighted Magnetic Resonance Imaging (DWI).
DWI sequences will be collected to detect changes in FA and MD (these indices are complementary and need to be considered together to be interpreted) to evaluate structural connectivity.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)2
Changes in Functional Connectivity (FC) as detected by resting state functional Magnetic Resonance Imaging (rs-fMRI)
Resting-State fMRI (Multi echo - Multi-Band) images will be collected for the assessment of the FC before and after intervention.
Time frame
Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Università Carlo Cattaneo , Castellanza
Collaborator
Astir s.r.l.
Collaborator
Source ClinicalTrials.gov