Cognitive AssessmentRTANCT05135806
Remote Testing in Abbiategrasso (RTA)
An observational study of Cognitive Assessment, run by Fondazione Golgi Cenci at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Assessment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- willingness to adhere to the study
- age between 65 and 85
- normal cognition
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study on Remote Cognitive Assessment With Older People. A Counter-balanced Crossover Trial.
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.
Read the 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.
- Conditions
- Cognitive Assessment
- Keywords
- remote neuropsychological assessment, feasibility study, counterbalanced cross-over design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (1)
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?
Measured: Day 1 and Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start21 Jun 2021
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cognitive AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Golgi Cenci
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Guaita, MD, Fondazione Golgi Cenci
- Investigators
- Roberta Vaccaro, MSc, Principal investigator, Fondazione Golgi Cenci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135806
- Sponsor's protocol ID
- 03
- Acronym
- RTA
- Status last verified
- Mar 2022
- First submitted
- 2 Nov 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data may be made available to third parties as aggregated data.
Publications
Orsini, A., & Pezzuti, L. (2013). WAIS-IV. Contributo alla taratura italiana. (Giunti OS.). Firenze.
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.
PubMed 33126634Backx 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.
PubMed 32749999Wong 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.
PubMed 25700290DeYoung 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.
PubMed 29320916Santangelo 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.
PubMed 25380622Carlesimo 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.
PubMed 8954307[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.
PubMed 3330072Novelli, 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.
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.
PubMed 23963806Serafin, M., & Surian, L. (2004). Il Test degli Occhi: uno strumento per valutare la "teoria della mente." Giornale Italiano Di Psicologia, 31(4), 839-862.
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.
PubMed 36710319
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on Remote Cognitive Assessment With Older People. A Counter-balanced Crossover Trial.
- ClinicalTrials.gov ID
- NCT05135806
- Acronym / sponsor ID
- RTA / 03
- Conditions
- Cognitive Assessment
- Keywords
- remote neuropsychological assessment, feasibility study, counterbalanced cross-over design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fondazione Golgi CenciUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- willingness to adhere to the study
- age between 65 and 85
- normal cognition
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment rate
Time frame: Day 0
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.
1 secondary outcome
Acceptability of remote cognitive tests among aged individuals (+65 years).
Time frame: Day 1 and Month 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- BackgroundOrsini, A., & Pezzuti, L. (2013). WAIS-IV. Contributo alla taratura italiana. (Giunti OS.). Firenze.
- Background: PubMed 33126634Rolandi 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.
- Background: PubMed 32749999Backx 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.
- Background: PubMed 25700290Wong 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.
- Background: PubMed 29320916DeYoung 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.
- Background: PubMed 25380622Santangelo 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.
- Background: PubMed 8954307Carlesimo 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.
- Background: PubMed 3330072[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.
- BackgroundNovelli, 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: PubMed 23963806Costa 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.
- BackgroundSerafin, M., & Surian, L. (2004). Il Test degli Occhi: uno strumento per valutare la "teoria della mente." Giornale Italiano Di Psicologia, 31(4), 839-862.
- Derived from this study: PubMed 36710319Vaccaro 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.
- Individual participant dataSharing planned: No. The data may be made available to third parties as aggregated data.
Related trials for Cognitive Assessment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS
Rheumatic Diseases, Pain, Chronic
Enrolling by invitation
Omega-3 Fatty Acids and Muscle Strength
Muscle Strength, Cognitive Function Assessment
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Recruiting
Evaluation of a Decision-Support Tool for Blood Biomarker Testing for Alzheimer's Disease in Primary Care
Cognitive Abnormality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta Vaccaro, MSc principal investigator
Fondazione Golgi Cenci
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Assessment, run by Fondazione Golgi Cenci at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05135806, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.