NCT05253612

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

December 22, 2021

Last Update Submit

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

OTHER

The 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

Diagnostic Test: Analog testing conducted by a trained test leader using, ISPOCD test batteryDiagnostic Test: self-administered Mindmore digital cognitive screening battery

Mindmore digitalized cognitive test battery

OTHER

Strating with Mindmore digitalized cognitive test battery followed by ISPOCD test battery, with 2 weeks passing between the cognitive testing for both groups

Diagnostic Test: Analog testing conducted by a trained test leader using, ISPOCD test batteryDiagnostic Test: self-administered Mindmore digital cognitive screening battery

Interventions

Cognitive function will be measured by using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) analog test battery v

ISPOCD test batteryMindmore digitalized cognitive test battery

Cognitive function will be measured by using the Mindmores digital test battery

ISPOCD test batteryMindmore digitalized cognitive test battery

Eligibility Criteria

Age60 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWe will ask for the biological gender
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

Study Officials

  • Ulrica Nilsson, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: The participants will be randomized to one of two conditions: 1) ISPOCD test battery followed by Mindmore digitalized cognitive test battery, or 2) Mindmore digitalized cognitive test battery followed by ISPOCD test battery, with 2 weeks passing between the cognitive testing for both groups
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

Locations