KANOPEE: Virtual Agents-based Digital Interventions to Improve Health

Sponsor
University of Bordeaux (Other)
Overall Status
Recruiting
CT.gov ID
NCT05074901
Collaborator
(none)
20,000
Enrollment
1
Location
2
Arms
92.3
Anticipated Duration (Months)
216.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: digital behavioral intervention
N/A

Detailed Description

KANOPEE was designed by sleep specialists and psychiatrists to propose autonomous interventions to improve sleep, physical activity and substance abuse ; aiming at lowering psycho-social stress's repercussions. The app provides weekly interactions with a virtual companion.

At each interaction, users answer standardized questionnaires (e.g., Insomnia Severity Index, Cigarette Dependence Scale) enabling to characterize users' health status (i.e;, the severity of the complaints) and evolution over time, and therefore provide adapted interventions based on the literature (e.g., digital Cognitive Behavioral Therapies, diaries, sleep hygiene recommendations, motivational interviewing).

The app is freely available to the general population in France, enabling very large sample size, and the possibility to perform non-randomized trials depending on the selected interventions by the users and the subject's group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open populational trialOpen populational trial
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
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
Actual Study Start Date :
Apr 22, 2020
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

ArmIntervention/Treatment
Experimental: digital behavioral intervention

Digital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage.

Behavioral: digital behavioral intervention
interaction with a conversational agent to implement physical and cognitive programs

No Intervention: e-diaries

Ecological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition.

Outcome Measures

Primary Outcome Measures

  1. Sleep complaints [weekly, from the downloading of the app until two weeks after the end of the intervention]

    measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint.

  2. Fatigue complaints [weekly, from the downloading of the app until two weeks after the end of the intervention]

    measured by the Fatigue Severity Scale (FSS), total score ranging from 1 to 7, higher score indicating higher perceived fatigue.

  3. Depression and anxiety complaints [weekly, from the downloading of the app until two weeks after the end of the intervention]

    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.

Secondary Outcome Measures

  1. Total Sleep Time [daily, from the downloading of the app until two weeks after the end of the intervention]

    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)

  2. Sleep Efficiency [daily, from the downloading of the app until two weeks after the end of the intervention]

    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)

  3. Time In Bed [daily, from the downloading of the app until two weeks after the end of the intervention]

    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).

  4. Sleep Onset Latency [daily, from the downloading of the app until two weeks after the end of the intervention]

    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)

  5. Wakefulness After Sleep Onset [daily, from the downloading of the app until two weeks after the end of the intervention]

    calculated based on the sleep diary data, corresponding to the total amount of time awake during the night (in hh:mm:ss)

  6. Number of Awakenings [daily, from the downloading of the app until two weeks after the end of the intervention]

    calculated based on the sleep diary data, corresponding to the total number of time awakenings during the night (number from 0 to 15)

  7. number of episodes of craving [daily, from the downloading of the app until two weeks after the end of the intervention]

    self-reporting number of moment during a day when the user felt the irresistible need to consume a substance (e.g., tobacco, alcohol)

  8. amount of substance usage [daily, from the downloading of the app until two weeks after the end of the intervention]

    self-reporting number of substance (e.g., cigarette, drinks) consumed during a day

Other Outcome Measures

  1. application's acceptance [facultative questionnaire that user can fill up after any interaction with the app (thus weekly)]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of BordeauxBordeauxFrance33000

Sponsors and Collaborators

  • University of Bordeaux

Investigators

  • Principal Investigator: Pierre Philip, Pr, University of Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pierre Philip, Professor, University of Bordeaux
ClinicalTrials.gov Identifier:
NCT05074901
Other Study ID Numbers:
  • CHUBX2020GSP0102
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pierre Philip, Professor, University of Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021