A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing

Study Overview
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Brief Summary
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Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app. Secondary: The rating by the Healthcare Professionals (HCPs) on the use and relevance of data provided by the LENA recorder in their general practice Exploratory Total crying and fussing time captured by the LENA recorder Crying and fussing time perceived by the parents Vital parameters like heart rate, sleep recorded by the Fitbit used by the primary caregiver during crying and fussing events registered by LENA Comments and feedback provided by the primary caregiver on the LENA recorder and the Cool mobile app Comments and feedback provided by the HCP on the LENA recorder and the data provided. Sleep time recorded by the Cocoon Cam Crying time recorded by the Cocoon Cam Crying start and end time recorded by the primary caregiver in the COOL app Sleep start and end time recorded by the primary caregiver in the COOL app Comments and feedback provided by the primary caregiver and HCP on the Cocoon Cam and the activity log for infant cry and sleep including push notifications in the Cocoon Cam app Usage data from the Cocoon Cam app

Detailed Description
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At screening visit, after parent(s)/guardian(s) of potential subjects and/or legal representatives have been informed about the study, they will be requested to sign the informed consent form (ICF) prior to start of the study. After successful signing of the informed consent, the investigator will assess the eligibility of the subjects. If the subject meets all the inclusion and none of the exclusion criteria, the primary caregiver will complete a detailed questionnaire on subject's demographics, birth, family, feeding characteristics and primary caregiver's characteristics. The primary caregiver will be provided the LENA recorder kit and in case consented for Fitbit, they will be provided with the Fitbit. The primary caregiver will need to complete a training period in order to verify subject's primary caregiver's ability to properly connect, operate and upload data using the LENA recorders and uploader. As part of the training period, the primary caregiver will do 1-2 hours of recording using the LENA recorder and successfully upload the data into the LENA cloud server through the internet. Once the study coordinator verifies that the upload is successful, the training and feasibility assessment will be considered as complete and the subject will be considered as enrolled. The primary caregiver of the enrolled subject will be provided access to the COOL mobile app and the recording period will start. During the recording period, the subject will be using the LENA recorder and will complete a daily questionnaire at the end of each day. At the end of 7 days, the site will perform a phone call and the LENA cry and fuss clock generated from the LENA recorder data for the recorded period will be shared with the primary caregiver through the COOL mobile app. After viewing the cry and fuss clock, the primary caregiver will need to complete a questionnaire on the use of LENA recorder and the content of the COOL mobile app. The primary caregiver will continue using the LENA recorder for the next 7 days. At the end of 14 days, the LENA cry and fuss data for the recorded period will be shared with the primary caregiver and the primary caregiver will need to complete another questionnaire on the use and relevance of the cry and fuss clock and overall relevance of the COOL mobile app. At the end of the recording period, the primary caregiver will schedule an appointment with the PI. If the primary caregiver consents for the use of Fitbit, they will be provided Fitbit to record their vital parameters like heartrate and sleep pattern through the 14 days after enrolment. At the end of study visit, the primary caregiver will discuss the data provided by the LENA recorder and the COOL mobile app with the PI and PI will use the data to explain to the primary care giver if there is any specific cry pattern that could be assessed based on the objective data from LENA. The Primary caregiver and PI will complete a questionnaire each on the use of the data provided by the LENA recorder during their discussion. For up to 5 subjects in the study, if the primary caregiver consents for the use of Cocoon Cam they will be provided with the Cocoon Cam kit at screening visit. The primary caregiver will need to complete a training period to verify the ability to properly connect, operate and upload data using the LENA recorders and uploader as well as the Cocoon Cam. As part of the training period, the primary caregiver will have to I) perform 1-2 hours of recording using the LENA recorder II) successfully upload the data into the LENA cloud server through the internet, III) use the Cocoon Cam for 1 day, and IV) be able to start using the Cocoon Cam application. Once the study coordinator verifies that the LENA upload is successful and Cocoon Cam set-up is complete, the training and feasibility assessment will be considered as complete and the subject will be considered as enrolled. The primary caregiver of the enrolled subject will be provided access to the COOL mobile app and the recording period will start. During the recording period, in addition to the daily questionnaire, the primary caregiver need to enter cry and sleep time using the COOL app. At the end of 7th day and 14th day, the primary caregiver need to complete questionnaires on the usability of the Cocoon Cam.

Official Title
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Cry Management and Awareness Tool (Cool): A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing

Conditions
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Healthy

Intervention / Treatment
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* Other: LENA recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants aged 2 to 12 months. Primary caregiver should have reliable access to the internet and a reliable device such as a computer, tablet or smart phone to access the Cool mobile app and able to view the LENA data and complete questionnaires. Primary caregiver should be adequately skilled comfortable in English to read the content in the Cool mobile app and complete questionnaires. Primary caregiver takes care of the child more than 50% of the time. Exclusion Criteria: Primary caregiver who is not adequately skilled comfortable in English language to read the content in the Cool mobile app and complete questionnaires. Incapability of the primary caregiver to access Cool mobile app through internet.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LENA<br>Lena device with Fitbit and Cocooncam being optional | Other: LENA recorder<br>* The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires<br>* Other names: Fitbit, Cool Mobile app,Cocoon Cam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rating by the Primary Caregivers on the Use and Relevance of the Cry and Fuss Clock Generated From the LENA Recorder Data and the Rating by the Primary Caregiver on the Level of Engagement Due to the Content on the COOL Mobile App. | Rating by the primary caregiver about the usability and relevance using a 6-point scale [0=Not at all, 5=Yes, very much]; Scale 1 to 4 is subjective to user definition (not defined specifically) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. | Rating by the HCP about the use and relevance of the LENA data in general practice using 6 point scale [0=Not at all, 5=Yes, very much], Scale 1 to 4 is subjective to user definition (not defined specifically) | 2 weeks |