Cognitive Trajectories After Surgery, a Clinical, Observational Feasibility Study
NCT05564195, Completed, Karolinska Institutet
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Trajectories After Surgery, a Clinical, Observational Feasibility Study | ClinicalTrials.gov |
| NCT number | NCT05564195 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 24 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Karolinska Institutet | ClinicalTrials.gov |
| Conditions | Postoperative Cognitive Dysfunction | ClinicalTrials.gov |
| Interventions | Postoperative cognitive function | ClinicalTrials.gov |
| First posted | 2022-10-03 | ClinicalTrials.gov |
| Last updated | 2024-11-12 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recruitment process and attrition rate | Through study completion, an average of 8 months | Number of possible participants vs. number of participants who accept to participate and number of participants who complete the study | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 1 | Before surgery and day 1 or 2, and 3 weeks after surgery | Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) A 10-word verbal learning test with 3 learning trials, a recall trial after \~7 min. | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 2 | Before surgery and day 1 or 2, and 3 weeks after surgery | Trail Making Test (TMT- A \& B), consisting of of 25 circles with letters or numbers on the screen. 4\. Symbol Digits Processing Test (SDPT).The test consist of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom of the screen. | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 3 | Before surgery and day 1 or 2, and 3 weeks after surgery | Stroop Colour-Word Test (SCW). 24 words spelling out a the name of a colour which is printed in contrasting ink colours (e.g., the word "green" printed with red ink), and the participant is asked to tell the printed colour of the word rather than the word rather than the actual meaning of the word. | ClinicalTrials.gov |
| Primary | Changes in postoperative cognitive function, part 4 | Before surgery and day 1 or 2, and 3 weeks after surgery | Symbol Digits Processing Test (SDPT).The test consist of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom of the screen. | ClinicalTrials.gov |
| Secondary | Frailty | Before surgery | Clinical Frailty Scale, including 9-item ranging from 1 - very vital to 9 - terminally ill. | ClinicalTrials.gov |
| Secondary | Signs of and changes in depression | Before surgery and 3 weeks after surgery | Geriatric Depression Scale (GDS), consisting of 15 items to be answered with Yes or No. A score of 5 to 10 indicates probable depression and a score of more than 10 indicates definite depression. | ClinicalTrials.gov |
| Secondary | Changes in functional capacity | Before surgery and 3 weeks after surgery | World Health Organization Disability Assessment Schedule 2.0 (WHODAS), thats consists of 12-item. Sum score ranges from 0-48, with increasing scores reflecting increasing disability | ClinicalTrials.gov |
| Secondary | Changes in postoperative recovery | Before surgery and day 1 or 2, and 3 weeks after surgery | Swedish version of Quality of Recovery, SwQoR, including 24 different postoperative symptoms to be rated on 11-point numerical scales from 0, "none of the time", to 10, "all of the time" Global score ranging from 0, "excellent quality of postoperative recovery," to 240, "extremely poor quality of recovery," with cutoff values of less than 31 at day 7 and less than 21 at day 14 indicating good recovery | ClinicalTrials.gov |
| Secondary | Usability of Mindmore-P | 3 weeks after surgery | System Usability Scale (SUS), consisting of 10 items to be answered on a 5-point scale from "strongly agree" to "strongly disagree". | ClinicalTrials.gov |
| Secondary | Feasibility and patients' experiences of early postoperative cognitive recovery | One month after surgery | Semi-structured, one-on-one interviews exploring patients' experiences of being assessed for cognitive performance and using Mindmore-P including assessment of facilitators and barriers, will be conducted. The participants will be asked to communicate freely on their experiences of their postoperative recovery. | ClinicalTrials.gov |
| Secondary | Signs of and changes in postoperative delirium | After surgery twice a day on postoperative day 1-2 | Nursing Delirium Screening Scale NU-DESC, an observational five-item scale where symptoms delirium are rated from 0 to 2. A score of 2 or more indicates delirium | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 37479514 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)