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Clinical Trials/NCT05898867
NCT05898867CompletedNot Applicable

Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis

Frederiksberg University Hospital1 site in 1 country103 target enrollmentStarted: June 7, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
103
Locations
1
Primary Endpoint
Concept maps.

Study Overview

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.

Detailed Description

Cognitive biases (systematic patterns of deviation from norm or rationality in judgment) and heuristics (tactics, or mental shortcuts to aid in the decision-making process) are increasingly being used in healthcare to facilitate good health decisions, improved care, and in designing new interventions.It has also been shown that cognitive biases influence how patients rate their own health.

Less is known about which specific cognitive biases and/or heuristics that are in play when patients with knee osteoarthritis form their treatment expectations and evaluate their health following an intervention.

This study aims to understand if certain cognitive biases and heuristics are present in patients with knee (OA) being treated with open label intra-articular placebo injections.

Understanding which cognitive biases and/or heuristics that are in play when these patients evaluate their health outcome following open label placebo, allows future treatment context to be designed in a way that actively utilises these cognitive biases and/or heuristics to obtain a greater magnitude of response.

A global predefined questionnaire, evaluating the presence and strength of the affect heuristic, is sent to all participants from the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480). In addition investigators will invite responders and non-responders respectively from the same study to group interviews in order to produce a structured conceptualisation map; the group content mapping method.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Have participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)

Exclusion Criteria

  • •Have not participated in the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480)

Outcomes

Primary Outcomes

Concept maps.

Time Frame: The GCM sessions are carried out approximately 1 year and 2 months after baseline.

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.

Secondary Outcomes

  • Strength of the affect heuristic in patients with knee OA(The questionnaire is administered approximately 1 year and 4 months after baseline.)

Investigators

Sponsor
Frederiksberg University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henning Bliddal

Professor

Frederiksberg University Hospital

Study Sites (1)

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