Telerehabilitation in Alzheimer's Disease
ConditionAlzheimer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorIRCCS San Raffaele
About this trial
Telemedicine has developed rapidly during the COVID-19 pandemic and is now integrated into the clinical practice of many hospitals. Telemedicine offers many advantages, and even after the end of the pandemic, many patients still choose to undergo healthcare visits remotely. However, the rapid expansion of telemedicine may be associated with the risk of providing patients with unvalidated and uncontrolled telehealth solutions, potentially negatively impacting their health.
In this study, the researchers aim to investigate the effectiveness of remote cognitive training in patients with mild-to-moderate Alzheimer's disease (AD) using tablets equipped with virtual reality-based cognitive exercises. The investigators also aim to evaluate the impact of online supervision of cognitive training by a neuropsychologist and to compare the costs and burden of home-based versus hospital-based cognitive training in patients with AD. This project will define the optimal modalities for cognitive telerehabilitation to ensure validated protocols for the continuity of care in AD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 50 and 90 years.
Diagnosis of Alzheimer's disease according to established diagnostic criteria.
Mini-Mental State Examination (MMSE) score between 18 and 24.
Stable pharmacological treatment for at least 3 months before enrolment.
Disqualifiers
Refusal or inability to provide written informed consent.
History of psychiatric disorders.
Significant cerebrovascular disease.
Severe visual or hearing impairment that could interfere with study procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
Online cognitive telerehabilitation
DeviceOnline sessions of cognitive telerehabilitation, twice a week, supervised by a neuropsychologist based at the San Raffaele hospital.
VRRS tablet
DevicePatients equipped with VRRS tablets to undergo autonomous home-based cognitive training (5 days a week).
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Tablet + TelerehabilitationExperimental treatment 2 interventions
Group B: Tablet onlyExperimental treatment 1 intervention
Group C: Telerehabilitation onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Montreal Cognitive Assessment (MoCA)
MoCA is a screening instrument to detect cognitive impairment. It generates a total score and six domain-specific index scores: (1) Memory, (2) Executive Functioning, (3) Attention, (4) Language, (5) Visuospatial, and (6) Orientation. The total possible score is 30 points; a score of 26 or above is considered normal, while scores below 26 may indicate cognitive impairment. Increase in MoCA scores meaning improvement in cognitive functioning.
Time frame
(1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.Secondary outcomes
1
Electroencephalographic (EEG) activity
Patients' electroencephalographic activity: 5 min of resting state EEG will be recorded using a 32 channel cap in order to perform time-frequency analyses before and after training. EEG power in the alpha, beta and theta rangers will be analyzed.
Time frame
(1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.2
Caregivers' mental status
\- Beck Depression Inventory-II (BDI): 21-item self-report instrument assessing the common cognitive symptoms of depression. BDI is considered a valid and reliable instrument for depression screening in the general population. The BDI is scored by summing the highest ratings for each of the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3, and the total scores can range from 0 to 63. BDI total scores ranging from 0 to 13 represent "Minimal" depression; total scores from 14 to 19 represent "Mild" depression; total scores from 20 to 28 represent "Moderate" depression; and total scores from 29 to 63 represent "Severe" depression.
Time frame
(1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.3
Caregivers' burden
Zarit Burden Interview: a standardized, 22-item assessment tool used by healthcare professionals to measure the subjective burden experienced by caregivers of individuals with chronic illnesses or dementia. It evaluates the emotional, physical, social, and financial impacts of caregiving to identify individuals at risk for burnout. It contains 22 questions rated on a 5-point scale (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Quite frequently, 4 = Nearly always). The total score ranges from 0 to 88, with higher scores indicating greater perceived strain.
Time frame
(1) before telerehabilitation, (2) at the end of the 3-month rehabilitation period, and (3) 3 months following the end of treatment.4
System usability
System Usability Scale (SUS): a reliable, 10-item questionnaire used in research to quickly measure the perceived usability of a product, software, or website. Usability measurements consider different aspects: effectiveness (users can successfully achieve their goals), efficiency (how much effort and resources are spent to achieve those goals) and satisfaction (the experience was satisfactory). Participants rate 10 statements (alternating positive and negative) on a 5-point scale (1 = Strongly Disagree, 5 = Strongly Agree), covering areas like ease of use, consistency, and complexity. A SUS score does not represent a percentage. Instead, scores are generally understood using standardized benchmarks and grading scales: (1) 80.3: Excellent (Grade A); (2) 71 - 80: Good (Grade B); (3) 68: Okay/Average; (4) 51 - 68: Poor (Grade C/D); (5) \<51: Worst Imaginable (Grade F).
Time frame
At the end of the 3-month rehabilitation period.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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