Remote Testing in Abbiategrasso (RTA)

Study Overview
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Brief Summary
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The remote cognitive assessment has the advantage of reaching people despite the restrictions due to the pandemic, so it is of fundamental importance both in the treatment of dementia and the research context. The scientific literature on the feasibility, acceptability and validity of remote neuropsychological assessment provides promising indications. However, the limitations related to access and familiarity with technologies in elderly populations, and to methodological aspects (e.g. the not-controlled environment, the validity of the remote assessment compared to the in-person assessment) remain to be clarified. For the present observational feasibility study, 58 older adults (65-85 years), randomly extracted among 93 eligible participants, will be recruited among donors of our Brain Bank. Participants will undergo both face-to-face and remote testing (via phone calls or videoconferencing) sessions in a counterbalanced cross-over design. The study will target (1) the recruitment rate in a study on remote testing, (2) the acceptability of remote cognitive tests and the procedures for delivering remote testing, (3) the comparability between remote and face-to-face performances on neuropsychological tests.

Detailed Description
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In February and March 2021, the 237 donors of our Brain Bank, aged between 65 and 98 and living at home, were interviewed by telephone. The purpose of the survey was to collect information on how they were experiencing the isolation linked to the pandemic in the last year, on health conditions and sleep, daily habits (nutrition, movement, leisure), use of the Internet and social networks as a way to maintain contact with one's family-friend network and experiences of loneliness (Rolandi et al, 2020). In this context, the willingness to participate in a study on remote cognitive assessment by phone, personal computer or tablet was explored. The sample size was calculated to estimate differences between testing conditions, i.e. face-to-face and remote testing (telephone or videoconference). A sample size of 52 is required to detect an effect size of 0.40 at 0.80% of power, in a paired-sample test with a normal distribution. We planned an increase in sample size of 6 participants, because the expected drop-out rate is 10% due to possible acute clinical conditions interfering with the participation in the study, or death. For the present observational feasibility study, 58 older adults (65-85 years), randomly extracted among 93 eligible participants, will be recruited among donors of the Brain Bank who previously have expressed the willingness to adhere to the study. Participants will undergo both face-to-face and remote testing sessions in a counterbalanced cross-over design. Each individual will undergo a comprehensive neuropsychological assessment consisting of a set of cognitive tests (memory, attention, etc) administered remotely via telephone calls or videoconferencing and face-to-face. Participants will be randomly allocated to one of the two conditions (remote first or face-to-face first). Each participant will take part to the second evaluation (remote or face-to-face) 8 weeks later. To reduce learning effect bias and intra-rate variability, this procedure will be counterbalanced so that half of the participants first experience the face-to-face interaction and the other half will initially receive the videoconference administration.

Official Title
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Feasibility Study on Remote Cognitive Assessment With Older People. A Counter-balanced Crossover Trial.

Conditions
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Cognitive Assessment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willingness to adhere to the study age between 65 and 85 normal cognition Exclusion Criteria: dementia, psychiatric or neurological diagnosis presence of a memory disorder with impact on the daily life reported by the person or detected by the interviewer previously scheduled follow-up of the Brain Bank

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Remote evaluation first: participants will undergo a comprehensive neuropsychological assessment administered remotely via telephone calls or videoconferencing. Each participant will take part to the second evaluation (face-to-face) 8 weeks later. | |
| Group 2<br>Face-to-face evaluation first: participants will undergo a comprehensive neuropsychological assessment administered face-to-face. Each participant will take part to the second evaluation (remotely via telephone calls or videoconferencing) 8 weeks later. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | The primary outcome is the recruitment of the 58 Brain Bank donors in our study on remote cognitive assessment. Fifteen days after the informed consent is sent, the healthcare assistant will conduct telephone calls to receive confirmation of participation in a remote cognitive assessment study from the donors who previously had expressed their willingness to adhere. The healthcare assistant will collect information about the reason of refusal if any (i.e. not interested, health problems, away from home for holidays). It will also asked confirmation of the modality preferred for the remote assessment, i.e. by phone, tablet or computer. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of remote cognitive tests among aged individuals (+65 years). | Immediately following each session of cognitive evaluation (both remotely and face-to-face) participants completed an acceptability questionnaire previously developed to evaluate the response to computerised cognitive tasks in both the clinic-based and home-based setting. Participants will be required to rate the enjoyability, level of anxiety, engagement, duration and repeatability of the tasks, rating them on a five-point Likert scale: 1, not at all; 2, a little bit; 3, neutral; 4, slightly; 5, very much. The questionnaire comprises the following questions: Did the test make you anxious? Did you enjoy the test? Did you find the test interesting? Would you be happy to repeat the test? What did you think about the duration of the test? | Day 1 and Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote neuropsychological assessment, feasibility study, counterbalanced cross-over design