Clinical trial NCT05135806: Remote Testing in Abbiategrasso (RTA)
Official title: Feasibility Study on Remote Cognitive Assessment With Older People. A Counter-balanced Crossover Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Assessment
Keywords: remote neuropsychological assessment
feasibility study
counterbalanced cross-over design
Lead sponsor: Fondazione Golgi Cenci
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In February and March 2021, the 237 donors of the Abbiategrasso 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 (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. 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 Abbiategrasso Brain Bank who previously have expressed the willingness to adhere to the study.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Day 0
Secondary outcomes:
measure: Acceptability of remote cognitive tests among aged individuals (+65 years).
timeFrame: Day 1 and Month 2
Other outcomes:
measure: Comparison between remote and face-to-face performances on the Montreal Cognitive Assessment (MoCA) Audiovisual
timeFrame: Day 1 and Month 2
measure: Comparison between remote and face-to-face performances on the MoCA 5-minute
timeFrame: Day 1 and Month 2
measure: Comparison between remote and face-to-face performances on the Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Day 1 and Month 2
measure: Comparison between remote and face-to-face performances on the Digit span forward and backward
timeFrame: Day 1 and Month 2
measure: Comparison between remote and face-to-face performances on the alternate phonemic/semantic fluency test
timeFrame: Day 1 and Month 2
measure: Comparison between remote and face-to-face performances on the Verbal reasoning test
timeFrame: Day 1 and Month 2
measure: Comparison between remote and face-to-face performances on the Constructional praxis
timeFrame: Day 1 and Month 2
measure: Comparison between remote and face-to-face performances on the Reading the Mind in the Eyes Test (RME)
timeFrame: Day 1 and Month 2
Locations:
city: Abbiategrasso
country: Italy
facility: Golgi cenci Foundation
state: Milan
Study officials:
affiliation: Fondazione Golgi Cenci
name: Roberta Vaccaro, MSc
role: PRINCIPAL_INVESTIGATOR
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