Comparison Between Analog Neurocognitive Tests Conducted by a Trained Test Leader Versus Self-administered Digital Tests
PICASU-Eq
1 other identifier
interventional
50
1 country
1
Brief Summary
The study has a randomized crossover design including qualitative interviews of the participant's test experiences. Healthy participants, ≥60 years are eligible to participate in the study. Cognitive function will be measured by using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) test battery and the Mindmore digital test battery. The participants will self-report their likelihood of depression with the geriatric depression scale-15, their user experience of the digital test by a modified version of System Usability scale, and answer questionnaires targeting their experiences of the test sessions. Furthermore, concentration difficulties, according to the Swedish Quality of Recovery-scale will also be measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2021
CompletedStudy Start
First participant enrolled
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2022
CompletedMarch 6, 2025
March 1, 2025
2 months
December 22, 2021
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
equivalence between the two tests
If the data is normal distributed Pearson correlation coefficient will be used to measure the association between ISPOCD and Mindmore four cognitive domains. If the data is non normally distributed Spearman rank correlation will be used. The values for the correlation coefficient irrespectively if using Person or Spearman range between -1.0 and 1.0. A correlation of -1.0 shows a perfect negative correlation, while a correlation of 1.0 shows a perfect positive correlation. However, a correlation equal to 0 does not imply the absence of association
through study completion, an average of 6 months
Secondary Outcomes (6)
Usability of the digital test version
through study completion, an average of 6 months
Acceptability and Feasibility (I)
through study completion, an average of 6 months
Acceptability and Feasibility (II)
through study completion, an average of 6 months
Concentration difficulties the past 24 hours
through study completion, an average of 6 months
Depression screening
through study completion, an average of 6 months
- +1 more secondary outcomes
Study Arms (2)
ISPOCD test battery
OTHERThe participants will be randomized to start with ISPOCD test battery followed by Mindmore digitalized cognitive test battery with 2 weeks passing between the cognitive testing for both groups
Mindmore digitalized cognitive test battery
OTHERStrating with Mindmore digitalized cognitive test battery followed by ISPOCD test battery, with 2 weeks passing between the cognitive testing for both groups
Interventions
Cognitive function will be measured by using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) analog test battery v
Cognitive function will be measured by using the Mindmores digital test battery
Eligibility Criteria
You may qualify if:
- \> 59 years of age
- ability to read and speak Swedish,
You may not qualify if:
- suffering from a nervous system disease,
- suffering from a severe psychiatric disorder
- alcoholism
- drug dependence
- severe visual or auditory disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ulrica Nilsson
Stockholm, 141 83, Sweden
Related Publications (1)
Amirpour A, Eckerblad J, Bergman L, Nilsson U. Comparing analog and digital neurocognitive tests with older adults: a study of the ISPOCD battery vs. a digital test battery from Mindmore. BMC Geriatr. 2024 Jan 8;24(1):34. doi: 10.1186/s12877-023-04648-w.
PMID: 38191318RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrica Nilsson, Professor
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 22, 2021
First Posted
February 24, 2022
Study Start
February 17, 2022
Primary Completion
April 5, 2022
Study Completion
April 5, 2022
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
deidentified/anonymous can be shared