Remote Testing in Abbiategrasso (RTA)

NCT05135806 | Completed

• 1 other identifier: 03
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Assessment

Keywords

remote neuropsychological assessment; feasibility study; counterbalanced cross-over design

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability of remote cognitive tests among aged individuals (+65 years).

  Day 1 and Month 2

Other Outcomes (8)

• Comparison between remote and face-to-face performances on the Montreal Cognitive Assessment (MoCA) Audiovisual

  Day 1 and Month 2

• Comparison between remote and face-to-face performances on the MoCA 5-minute

  Day 1 and Month 2

• Comparison between remote and face-to-face performances on the Rey Auditory Verbal Learning Test (RAVLT)

  Day 1 and Month 2

Study Arms (2)

Group 1

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

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.

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• willingness to adhere to the study
• age between 65 and 85
• normal cognition

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Golgi Cenci: lead

Study Sites (1)

Golgi cenci Foundation

Abbiategrasso, Milan, 20081, Italy

Location

Related Publications (12)

• Orsini, A., & Pezzuti, L. (2013). WAIS-IV. Contributo alla taratura italiana. (Giunti OS.). Firenze.

  BACKGROUND

• Rolandi E, Vaccaro R, Abbondanza S, Casanova G, Pettinato L, Colombo M, Guaita A. Loneliness and Social Engagement in Older Adults Based in Lombardy during the COVID-19 Lockdown: The Long-Term Effects of a Course on Social Networking Sites Use. Int J Environ Res Public Health. 2020 Oct 28;17(21):7912. doi: 10.3390/ijerph17217912.

  PMID: 33126634 BACKGROUND

• Backx R, Skirrow C, Dente P, Barnett JH, Cormack FK. Comparing Web-Based and Lab-Based Cognitive Assessment Using the Cambridge Neuropsychological Test Automated Battery: A Within-Subjects Counterbalanced Study. J Med Internet Res. 2020 Aug 4;22(8):e16792. doi: 10.2196/16792.

  PMID: 32749999 BACKGROUND

• Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19.

  PMID: 25700290 BACKGROUND

• DeYoung N, Shenal BV. The reliability of the Montreal Cognitive Assessment using telehealth in a rural setting with veterans. J Telemed Telecare. 2019 May;25(4):197-203. doi: 10.1177/1357633X17752030. Epub 2018 Jan 10.

  PMID: 29320916 BACKGROUND

• Santangelo G, Siciliano M, Pedone R, Vitale C, Falco F, Bisogno R, Siano P, Barone P, Grossi D, Santangelo F, Trojano L. Normative data for the Montreal Cognitive Assessment in an Italian population sample. Neurol Sci. 2015 Apr;36(4):585-91. doi: 10.1007/s10072-014-1995-y. Epub 2014 Nov 8.

  PMID: 25380622 BACKGROUND

• Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297.

  PMID: 8954307 BACKGROUND

• [Italian standardization and classification of Neuropsychological tests. The Italian Group on the Neuropsychological Study of Aging]. Ital J Neurol Sci. 1987 Dec;Suppl 8:1-120. No abstract available. Italian.

  PMID: 3330072 BACKGROUND

• Novelli, G., Papagno, C., Capitani, E., Laiacona, M., Vallar, G., & Cappa, S. (1986). Tre test clinici di ricerca e produzione lessicale: taratura su soggetti normali. Archivio Di Psicologia Neurologia e Psichiatria, (4), 477-506.

  BACKGROUND

• Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21.

  PMID: 23963806 BACKGROUND

• Serafin, M., & Surian, L. (2004). Il Test degli Occhi: uno strumento per valutare la "teoria della mente." Giornale Italiano Di Psicologia, 31(4), 839-862.

  BACKGROUND

• Vaccaro R, Aglieri V, Rossi M, Pettinato L, Ceretti A, Colombo M, Guaita A, Rolandi E. Remote testing in Abbiategrasso (RTA): results from a counterbalanced cross-over study on direct-to-home neuropsychology with older adults. Aging Clin Exp Res. 2023 Mar;35(3):699-710. doi: 10.1007/s40520-023-02343-9. Epub 2023 Jan 30.

  PMID: 36710319 DERIVED

Study Officials

• Roberta Vaccaro, MSc

  Fondazione Golgi Cenci

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 26, 2021
• Study Start: June 21, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)