Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02907034
Other study ID # RCAPHM16_0016
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 12, 2016
Last updated September 19, 2016
Start date January 2017
Est. completion date January 2021

Study information

Verified date September 2016
Source Assistance Publique Hopitaux De Marseille
Contact Pascal AUQUIER, MD-PhD
Email pascal.auquier@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Financials constraints of health systems require suitable indices and criteria to better allocate resources in order to enhance and maximize social welfare. Among multiple methods, the quality-adjusted life year (QALY) is used as a validated and preference-base measure for health care procedures in health economics studies such as cost-utility analyses.

In France, the methodological guide of the public agency of the High Authority for Health (HAS) recommends the valuation of health states with the use of a generic and descriptive instrument (EQ5D), validated by the Time Trade Off method (TTO) in samples from general French population.

Although it appears to be legitimate to distribute collective resources based on general population preferences, a major concern is that individuals do not face a real choice that can have a direct implication on their welfare and their life.

The existence of a discrepancy between revealed "hypothetical" preferences and real preferences would raise the problem concerning production of the currently available standards and norms. Hence, a methodological deepening of these preferences revelation process is necessary.

Virtual reality (VR) could play a key role in resolving this methodological problem. Widely used in the field of health (such as therapy, medical training...), VR is a simulation that seeks to approach the reality, without trying to be quite like it. It aims one or more individuals to explore a sensorimotor and cognitive activity in an artificial world in 3D, which can be "imaginary, symbolic or a simulation of some aspects of the real world" (Fuchs, 2006). VR could be well applied to the field of health economics by offering hypothetical scenarios of the different health states from the EQ5D that individuals might experience in the first person.

To date, existence of this discrepancy between revealed "hypothetical" preferences and actual preferences of individuals from the general population is extremely difficult to explore. However, this is an important methodological challenge in the revelation of preferences to guide health-related decisions.

Indeed, comparing the revealed preferences about health states established from a first person experience in VR to the revealed preferences established from the classic narrative approach without VR, may provide an accurate approach of actual and real preferences of individuals from the general population.

Moreover, another advantage of VR is to permit the assessment of a greater number of health states, this method being faster processed than the narrative approach: individuals are experimenting immediate experience of a situation when under VR. Thus, VR method may overcome technical constraints of the classic narrative approach concerning limited sample sizes in norms production.

To the investigators knowledge, VR has never been proposed for valuating health conditions.

This study would report the relevance and interest in using VR (immersive and immediate life situation experience) for the production of utility EQ5D health states values in the general population by the revelation of preferences method called the Time Trade Off (TTO), the currently approach recommended by the HAS.

Using VR could circumvent some limitations of the current narrative approach: it would provide a better feasibility and acceptability among subjects, fewer inconsistencies, an easier and wider access to disadvantaged individuals. Eventually revisions of available standards could be proposed to allow the HAS and policy makers to base their choices on more reliable, standardized and accurate classifications of health states conditions, that associate each health state to a predefined value.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date January 2021
Est. primary completion date January 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject without major vision problem, judged clinically

- Subject without major auditive problem, judged clinically

Exclusion Criteria:

- Subject unable to read and understand French

- Subject covered by a the french social security system

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Procedure:
Virtual reality experimentation sequency (VR)

Classical narrative approach (CN)


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average number of overall inconsistency produced by an individual following health states preferences elicitation test under VR compared to test under the classic and conventional narrative approaches 6 hours No
See also
  Status Clinical Trial Phase
Completed NCT00651248 - Evaluation of Salivary Flow and Buffer Capacity Associated to Aged People's Oral Health N/A
Recruiting NCT05655962 - A Structured Framework for Assessment of Rehabilitation and Sicklisting in Primary Care - a Multicenter Study N/A
Active, not recruiting NCT05293431 - Promote Brain Resilience for the Coronavirus (COVID-19) Pandemic N/A
Completed NCT04524286 - Role of Midwifery Continuity of Care in Reducing Health Inequalities
Completed NCT00836459 - Sheffield Physical Activity Booster Trial N/A
Completed NCT04276103 - Surgical Assessment Tool for Ethiopia National Policy Monitoring & Evaluation
Completed NCT02843360 - National Health Interview Survey in Taiwan N/A
Completed NCT06303700 - Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups
Completed NCT06400758 - Impact/Interest of a Collective Prevention Intervention in Sexual and Emotional Health
Recruiting NCT04584944 - Appendicular Skeletal Muscle Mass Study
Recruiting NCT04886427 - Implementation of a Multidimensional Quality Model
Recruiting NCT04242433 - HCV RAS Testing in Public Health Programs
Recruiting NCT05739305 - Death Certificate Analysis at Colombian Orinoquia: A Retrospective Observational Trial.
Completed NCT05702008 - Social Media as an Information, Education and Communication Tool for Rabies Prevention: An Interventional Study N/A
Completed NCT02785107 - Exercise Habit and M-PAC Phase 2/Phase 3
Completed NCT04651751 - Exercise Habit & MPAC N/A
Active, not recruiting NCT02905500 - Estimation of Disability Adjusted Life Years in Reunion Island and Comparison to Metropolitan France and Other Countries in the Indian Ocean Zone N/A
Completed NCT00643019 - Project Sexual Awareness for Everyone (SAFE) Phase 3
Completed NCT04258540 - The Effects of Yoga on Student Mental Health N/A
Recruiting NCT05206643 - Shanghai Pudong Cohort