Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05898867
• Other study ID #: CHIPS
• Status: Completed
• Start date: June 7, 2023
• Est. completion date: October 5, 2023

Study information

• Verified date: March 2024
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Saline
Open label intra-articular injection of isotonic saline.

Locations

Country	Name	City	State
Denmark	Bispebjerg-Frederiksberg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Strength of the affect heuristic in patients with knee OA	Using a questionnaire tool investigators will asses the strength of the affect heuristic with participants from from the study "Reinforcement of Treatment Response in Knee Osteoarthritis: A Randomised Trial" (Clinical trial.gov registration: NCT05225480).; The strength of the affect heuristic is expressed via the correlation coefficient which ranges from (-1 to 1) and the 95% confidence interval.	The questionnaire is administered approximately 1 year and 4 months after baseline.