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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Insomnia; Anxiety; Mental Disorder; Mental Stress
• Intervention / Treatment: Behavioral: digital behavioral intervention

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 Type: Interventional
• Enrollment (Anticipated): 20000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Philip, Pr; Phone Number: +33557820172; Email: pierre.philip@u-bordeaux.fr
• Study Contact Backup: Name: Etienne de Sevin, Ph.D.; Phone Number: +33547304242; Email: etienne.de-sevin@u-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • University of Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	daily, from the downloading of the app until two weeks after the end of the intervention
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)	daily, from the downloading of the app until two weeks after the end of the intervention
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).	daily, from the downloading of the app until two weeks after the end of the intervention
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)	daily, from the downloading of the app until two weeks after the end of the intervention
Wakefulness After Sleep Onset	calculated based on the sleep diary data, corresponding to the total amount of time awake during the night (in hh:mm:ss)	daily, from the downloading of the app until two weeks after the end of the intervention
Number of Awakenings	calculated based on the sleep diary data, corresponding to the total number of time awakenings during the night (number from 0 to 15)	daily, from the downloading of the app until two weeks after the end of the intervention
number of episodes of craving	self-reporting number of moment during a day when the user felt the irresistible need to consume a substance (e.g., tobacco, alcohol)	daily, from the downloading of the app until two weeks after the end of the intervention
amount of substance usage	self-reporting number of substance (e.g., cigarette, drinks) consumed during a day	daily, from the downloading of the app until two weeks after the end of the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	facultative questionnaire that user can fill up after any interaction with the app (thus weekly)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: e-health; ecological momentary assessment; ecological momentary intervention; embodied conversational agent
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Mental Disorders
• Other Study ID Numbers: CHUBX2020GSP0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No