Virtual Agents-based Digital Interventions to Improve Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bordeaux
About this trial
KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population.
Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions.
The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being aged 18 years old and over (the app is available for younger users but their data will not be analyzed)
having downloaded the app
having a smartphone Android or Iphone
being located in France
Disqualifiers
having clicked on the "emergency button" (in the app, there is a warning message : this app is not for emergency situations. If you need an urgent psychological support, click here")
having downloaded the app but without answering any questionnaire
Trial design
Design model
Parallel
Treatments tested in this trial
digital behavioral intervention
Behavioralinteraction with a conversational agent to implement physical and cognitive programs
Treatment groups
20,000 Participants
are divided into 2 treatment groupsGroup A: digital behavioral interventionExperimental treatment 1 intervention
Group B: e-diariesNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sleep complaints
measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint.
Time frame
weekly, from the downloading of the app until two weeks after the end of the intervention2
Fatigue complaints
measured by the Fatigue Severity Scale (FSS), total score ranging from 1 to 7, higher score indicating higher perceived fatigue.
Time frame
weekly, from the downloading of the app until two weeks after the end of the intervention3
Depression and anxiety complaints
measured by the Patient Health Questionnaire 4 items (PHQ-4), total score ranging from 0 to 12, higher scores indicating higher depression or anxiety complaints.
Time frame
weekly, from the downloading of the app until two weeks after the end of the interventionSecondary outcomes
1
Total Sleep Time
calculated based on the sleep diary data, corresponding to the actual time slept (Time in Bed - Sleep Onset Latency - Wakefulness After Sleep Onset - Terminal Wakefulness) (in hh:mm:ss)
Time frame
daily, from the downloading of the app until two weeks after the end of the intervention2
Sleep Efficiency
calculated based on the sleep diary data, corresponding to the percent of time in bed spent asleep (Total Sleep Time/Time in Bed \* 100) (percentage)
Time frame
daily, from the downloading of the app until two weeks after the end of the intervention3
Time In Bed
calculated based on the sleep diary data, time starting from the moment of intention to fall asleep and concluding with the final arising (in hh:mm:ss).
Time frame
daily, from the downloading of the app until two weeks after the end of the intervention4
Sleep Onset Latency
calculated based on the sleep diary data, corresponding to the time it takes to fall asleep, starting from the moment of intention to fall asleep (in hh:mm:ss)
Time frame
daily, from the downloading of the app until two weeks after the end of the interventionOther outcomes
1
application's acceptance
measured by the Acceptability of E-health Scale (AES), total score ranging from 0 to 30, higher score indicating a better acceptance of the app
Time frame
facultative questionnaire that user can fill up after any interaction with the app (thus weekly)Sponsors and contacts
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Source ClinicalTrials.gov