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| Name | Class |
|---|---|
| Tech Observer | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LENA | Other | Lena device with Fitbit and Cocooncam being optional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LENA recorder | Other | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Parameter :Total Crying and Fussing Time Captured by the LENA Recorder | Exploratory Parameter : Total daily crying and fussing time captured by the LENA recorder in minutes | 2 weeks |
| Exploratory Parameter :Crying and Fussing Time Perceived by the Parents |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBCC Clinic Pte Ltd | Singapore | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | LENA | Lena device with Fitbit and Cocooncam being optional LENA recorder: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LENA | Lena device with Fitbit and Cocooncam being optional LENA recorder: 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | 2 weeks |
|
15 days (Day 0 to Day 14)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LENA | Lena device with Fitbit and Cocooncam being optional LENA recorder: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Digital Project Manager | Danone Asia Pacific Holdings | 82281172 | jill.wong@danone.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2019 | May 29, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2019 | Jun 23, 2020 | SAP_001.pdf |
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|
Daily duration of cry and/or fuss in the scale of : <30 mins 30 mins to 1hr >1hr to 3hrs > 3hrs |
| 2 weeks |
| Usage Time of the Cocoon Cam App by the Primary Caregiver | Usage time (in minutes) of the Cocoon Cam app by the primary caregiver. | 2 weeks |
| To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice | To explore the usability of Cocoon Cam and data captured by the Cocoon Cam app for the HCP in their daily practice. Scale 0 = Not at all, Scale 5 = Yes very much. Scale 1 to 4 is subjective to user definition (not defined specifically) | 2 weeks |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Other Pre-specified | Exploratory Parameter :Total Crying and Fussing Time Captured by the LENA Recorder | Exploratory Parameter : Total daily crying and fussing time captured by the LENA recorder in minutes | Posted | Mean | Standard Deviation | minutes | 2 weeks |
|
|
|
| Other Pre-specified | Exploratory Parameter :Crying and Fussing Time Perceived by the Parents | Daily duration of cry and/or fuss in the scale of : <30 mins 30 mins to 1hr >1hr to 3hrs > 3hrs | The question was asked everyday within the 2 weeks' time frame. Data used to estimate number of participant days over (15 days x 20 participants) 300 participant days for each category of cry. For example, over a period of 15 days (Day 0 to Day 14) equivalent to 2 weeks time frame, the category "<30 mins" was selected 105 times by 20 participants. | Posted | Number | participant days | 2 weeks | participant days | participant days |
|
|
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| Other Pre-specified | Usage Time of the Cocoon Cam App by the Primary Caregiver | Usage time (in minutes) of the Cocoon Cam app by the primary caregiver. | 20 participants enrolled into study, 5 participants enrolled to use cocoon cam app but only 4 had data as 1 had wifi issue connecting to cocoon cam app. | Posted | Mean | Full Range | minutes | 2 weeks |
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|
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| Other Pre-specified | To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice | To explore the usability of Cocoon Cam and data captured by the Cocoon Cam app for the HCP in their daily practice. Scale 0 = Not at all, Scale 5 = Yes very much. Scale 1 to 4 is subjective to user definition (not defined specifically) | 5 participants enrolled to cocoon cam app use but 1 participant had issue with wifi connection so only 4 had data | Posted | Count of Participants | Participants | 2 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| Use and relevance Scale 3 |
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| Use and relevance Scale 4 |
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| Use and relevance Scale 5 - Yes, very much |
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| Title | Measurements |
|---|---|
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| >3hrs |
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| Missing |
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| Use and relevance Scale 3 |
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| Use and relevance Scale 4 |
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| Use and relevance Scale 5 - Yes, very much |
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