Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis

Sponsor
Frederiksberg University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05898867
Collaborator
(none)
100
1
4.8
20.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Saline

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
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Cognitive Bias and Heuristics in Patients With Knee Osteoarthritis
Anticipated Study Start Date :
Jun 7, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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)

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

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).

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

Outcome Measures

Primary Outcome Measures

  1. Concept maps. [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 Outcome Measures

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

    Using a questionnaire tool developed by (Skagerlund K, Forsblad M, Slovic P, Västfjäll D. The Affect Heuristic and Risk Perception - Stability Across Elicitation Methods and Individual Cognitive Abilities. Front Psychol. 2020 Jun 12;11:970) 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bispebjerg-Frederiksberg Hospital Copenhagen Denmark 2000

Sponsors and Collaborators

  • Frederiksberg University Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT05898867
Other Study ID Numbers:
  • CHIPS
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023