NCT02907034

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

September 12, 2016

Last Update Submit

September 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group 1

EXPERIMENTAL

First,Virtual reality approach (VR), then classical narrative approach (CN)

Procedure: Virtual reality experimentation sequency (VR)Procedure: Classical narrative approach (CN)

Group 2

ACTIVE COMPARATOR

First, classical narrative approach (CN), then virtual reality approach

Procedure: Virtual reality experimentation sequency (VR)Procedure: Classical narrative approach (CN)

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject without major vision problem, judged clinically
  • Subject without major auditive problem, judged clinically

You may not qualify if:

  • Subject unable to read and understand French
  • Subject covered by a the french social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • Ureielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR
  • Pascal AUQUIER, MD-PhD

    Assistance Publique Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal AUQUIER, MD-PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 20, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations