Virtual Agents-based Digital Interventions to Improve Health
KANOPEE
Acceptance and Efficacy of a Smartphone-based App Using a Conversational Agent to Monitor Health Status and/or Deliver Behavioral Intervention to Reduce Psycho-social Stress
1 other identifier
interventional
20,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2020
CompletedFirst Submitted
Initial submission to the registry
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
October 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
October 12, 2021
September 1, 2021
6.7 years
September 20, 2021
September 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sleep complaints
measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint.
weekly, from the downloading of the app until two weeks after the end of the intervention
Fatigue complaints
measured by the Fatigue Severity Scale (FSS), total score ranging from 1 to 7, higher score indicating higher perceived fatigue.
weekly, from the downloading of the app until two weeks after the end of the intervention
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.
weekly, from the downloading of the app until two weeks after the end of the intervention
Secondary Outcomes (8)
Total Sleep Time
daily, from the downloading of the app until two weeks after the end of the intervention
Sleep Efficiency
daily, from the downloading of the app until two weeks after the end of the intervention
Time In Bed
daily, from the downloading of the app until two weeks after the end of the intervention
Sleep Onset Latency
daily, from the downloading of the app until two weeks after the end of the intervention
Wakefulness After Sleep Onset
daily, from the downloading of the app until two weeks after the end of the intervention
- +3 more secondary outcomes
Other Outcomes (1)
application's acceptance
facultative questionnaire that user can fill up after any interaction with the app (thus weekly)
Study Arms (2)
digital behavioral intervention
EXPERIMENTALDigital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage.
e-diaries
NO INTERVENTIONEcological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition.
Interventions
interaction with a conversational agent to implement physical and cognitive programs
Eligibility Criteria
You may qualify if:
- 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
- having accepted the electronic informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bordeaux
Bordeaux, 33000, France
Related Publications (1)
Sagaspe P, Sanchez-Ortuno MM, Dupuy L, Pecune F, Coelho J, Micoulaud-Franchi JA, Levavasseur Y, de Sevin E, Chanteclair A, Philip P, Salles N. Perceptions and Effectiveness of a Fully Automated Brief Behavioral Insomnia Therapy, Delivered by a Virtual Companion, in Older and Young Adults. Innov Aging. 2024 Sep 24;9(2):igae086. doi: 10.1093/geroni/igae086. eCollection 2025.
PMID: 40206328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Philip, Pr
University of Bordeaux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 20, 2021
First Posted
October 12, 2021
Study Start
April 22, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
October 12, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share