Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis
1 other identifier
observational
103
1 country
1
Brief Summary
This study aims to understand if certain cognitive biases and heuristics are present in patients with knee osteoarthritis being treated with open label placebo (saline injections in the knee). A predefined survey will investigate the affect heuristic and group interviews patients who have responded well or not so well respectively will be used to examine if other cognitive biases or heuristics are present. Cognitive biases are systematic patterns of deviation from norm or rationality in judgment, while heuristics are tactics, or mental shortcuts to aid in the decision-making process.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2023
Shorter than P25 for all trials
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
May 10, 2023
CompletedStudy Start
First participant enrolled
June 7, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2023
CompletedMarch 15, 2024
March 1, 2024
4 months
May 10, 2023
March 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Concept maps.
Using the Group Concept Mapping (GCM) method investigators will generate concept maps from non-responders and responders respectively, from participants from the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480) Responders are defined as the those patients that had the largest change (4th quartile) to the pain Visual Analog Scale (VAS) (0-100mm). Non-responders are defined as the 1st quartile (least change). GCM is a formal group process using a structured approach to identify ideas on a topic of interest and organise them into domains based on a mixed-method participatory design that incorporates group processes and multivariate statistical analyses (multidimensional scaling and hierarchical cluster analysis). Using the concept maps and statements, investigators will assess similarities with known cognitive biases or heuristics.
The GCM sessions are carried out approximately 1 year and 2 months after baseline.
Secondary Outcomes (1)
Strength of the affect heuristic in patients with knee OA
The questionnaire is administered approximately 1 year and 4 months after baseline.
Study Arms (2)
Responders
Participants from the trial "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" will be defined as responders if they belong to the upper quartile of the change to the pain Visual Analogue Scale (VAS) (those who had the greatest positive changes)
Non-responders
Participants from the trial "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" will be defined as non-responders if they belong to the lower quartile of the change to the pain Visual Analogue Scale (VAS) (those who had the smallest change).
Interventions
Eligibility Criteria
People over 50 years of age with tibiofemoral knee osteoarthritis according to the American College of Rheumatology with an average knee pain in the last week during weight bearing activities of at least 4 on a 0 to 10 points VAS scale (0=no pain; 10=worst possible pain).
You may qualify if:
- Have participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)
You may not qualify if:
- Have not participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg-Frederiksberg Hospital
Copenhagen, 2000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 10, 2023
First Posted
June 12, 2023
Study Start
June 7, 2023
Primary Completion
October 5, 2023
Study Completion
October 5, 2023
Last Updated
March 15, 2024
Record last verified: 2024-03