Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT05135806
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Testing in Abbiategrasso (RTA)
Sponsor:
Fondazione Golgi Cenci
Organization:
Study Overview
Official Title:
Feasibility Study on Remote Cognitive Assessment With Older People. A Counter-balanced Crossover Trial.
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RTA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: