Virtual Agents-based Digital Interventions to Improve Health (KANOPEE)
Primary Purpose
Mental Disorder, Mental Stress, Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
digital behavioral intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Disorder focused on measuring e-health, embodied conversational agent, ecological momentary assessment, ecological momentary intervention
Eligibility Criteria
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
Sites / Locations
- University of BordeauxRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
digital behavioral intervention
e-diaries
Arm Description
Digital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage.
Ecological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition.
Outcomes
Primary Outcome Measures
Sleep complaints
measured by the Insomnia Severity Index (ISI), total score ranging from 0 to 28, higher score indicating higher sleep complaint.
Fatigue complaints
measured by the Fatigue Severity Scale (FSS), total score ranging from 1 to 7, higher score indicating higher perceived fatigue.
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.
Secondary Outcome Measures
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)
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 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).
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)
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)
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)
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)
amount of substance usage
self-reporting number of substance (e.g., cigarette, drinks) consumed during a day
Full Information
NCT ID
NCT05074901
First Posted
September 20, 2021
Last Updated
September 29, 2021
Sponsor
University of Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT05074901
Brief Title
Virtual Agents-based Digital Interventions to Improve Health
Acronym
KANOPEE
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Mental Stress, Insomnia, Depression, Anxiety
Keywords
e-health, embodied conversational agent, ecological momentary assessment, ecological momentary intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open populational trial
Masking
Participant
Allocation
Non-Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
digital behavioral intervention
Arm Type
Experimental
Arm Description
Digital behavioral interventions to improve mood and decrease fatigue, sleep complaints and substance usage.
Arm Title
e-diaries
Arm Type
No Intervention
Arm Description
Ecological momentary assessment based on e-diaries on a weekly basis to evaluate sleep/wake schedules, physical activity, substance usage and nutrition.
Intervention Type
Behavioral
Intervention Name(s)
digital behavioral intervention
Intervention Description
interaction with a conversational agent to implement physical and cognitive programs
Primary Outcome Measure Information:
Title
Sleep complaints
Description
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 intervention
Title
Fatigue complaints
Description
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 intervention
Title
Depression and anxiety complaints
Description
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 intervention
Secondary Outcome Measure Information:
Title
Total Sleep Time
Description
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 intervention
Title
Sleep Efficiency
Description
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 intervention
Title
Time In Bed
Description
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 intervention
Title
Sleep Onset Latency
Description
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 intervention
Title
Wakefulness After Sleep Onset
Description
calculated based on the sleep diary data, corresponding to the total amount of time awake during the night (in hh:mm:ss)
Time Frame
daily, from the downloading of the app until two weeks after the end of the intervention
Title
Number of Awakenings
Description
calculated based on the sleep diary data, corresponding to the total number of time awakenings during the night (number from 0 to 15)
Time Frame
daily, from the downloading of the app until two weeks after the end of the intervention
Title
number of episodes of craving
Description
self-reporting number of moment during a day when the user felt the irresistible need to consume a substance (e.g., tobacco, alcohol)
Time Frame
daily, from the downloading of the app until two weeks after the end of the intervention
Title
amount of substance usage
Description
self-reporting number of substance (e.g., cigarette, drinks) consumed during a day
Time Frame
daily, from the downloading of the app until two weeks after the end of the intervention
Other Pre-specified Outcome Measures:
Title
application's acceptance
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Philip, Pr
Phone
+33557820172
Email
pierre.philip@u-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Etienne de Sevin, Ph.D.
Phone
+33547304242
Email
etienne.de-sevin@u-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Philip, Pr
Organizational Affiliation
University of Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Agents-based Digital Interventions to Improve Health
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