Trial Outcomes & Findings for A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing (NCT NCT03729960)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

2 weeks

Results posted on

2020-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LENA n=20 Participants 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
Age, Continuous	5.77 months STANDARD_DEVIATION 2.87 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian	18 Participants n=5 Participants
Race/Ethnicity, Customized Others	2 Participants n=5 Participants
Region of Enrollment Singapore	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

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)

Outcome measures

Outcome measures
Measure	LENA n=20 Participants Lena device with both 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
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. Use and relevance scale 0 - Not at all	3 Participants
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. Use and relevance Scale 1	1 Participants
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. Use and relevance Scale 2	3 Participants
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. Use and relevance Scale 3	6 Participants
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. Use and relevance Scale 4	7 Participants
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. Use and relevance Scale 5 - Yes, very much	0 Participants

SECONDARY outcome

Timeframe: 2 weeks

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)

Outcome measures

Outcome measures
Measure	LENA n=20 Participants Lena device with both 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
The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. Use and relevance scale 0 - Not at all	0 Participants
The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. Use and relevance Scale 1	0 Participants
The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. Use and relevance Scale 2	6 Participants
The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. Use and relevance Scale 3	6 Participants
The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. Use and relevance Scale 4	8 Participants
The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. Use and relevance Scale 5 - Yes, very much	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Exploratory Parameter : Total daily crying and fussing time captured by the LENA recorder in minutes

Outcome measures

Outcome measures
Measure	LENA n=20 Participants Lena device with both 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
Exploratory Parameter :Total Crying and Fussing Time Captured by the LENA Recorder	19.6 minutes Standard Deviation 30.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Population: 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.

Daily duration of cry and/or fuss in the scale of : \<30 mins 30 mins to 1hr \>1hr to 3hrs \> 3hrs

Outcome measures

Outcome measures
Measure	LENA n=300 participant days Lena device with both 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
Exploratory Parameter :Crying and Fussing Time Perceived by the Parents >3hrs	16 participant days
Exploratory Parameter :Crying and Fussing Time Perceived by the Parents Missing	11 participant days
Exploratory Parameter :Crying and Fussing Time Perceived by the Parents < 30 mins	105 participant days
Exploratory Parameter :Crying and Fussing Time Perceived by the Parents 30 mins to 1hr	86 participant days
Exploratory Parameter :Crying and Fussing Time Perceived by the Parents >1hr to 3hrs	82 participant days

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Population: 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.

Usage time (in minutes) of the Cocoon Cam app by the primary caregiver.

Outcome measures

Outcome measures
Measure	LENA n=5 Participants Lena device with both 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
Usage Time of the Cocoon Cam App by the Primary Caregiver	4.1 minutes Interval 0.0 to 14.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Population: 5 participants enrolled to cocoon cam app use but 1 participant had issue with wifi connection so only 4 had data

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)

Outcome measures

Outcome measures
Measure	LENA n=5 Participants Lena device with both 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
To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice Use and relevance scale 0 - Not at all	1 Participants
To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice Use and relevance Scale 1	0 Participants
To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice Use and relevance Scale 2	2 Participants
To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice Use and relevance Scale 3	2 Participants
To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice Use and relevance Scale 4	0 Participants
To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice Use and relevance Scale 5 - Yes, very much	0 Participants

Adverse Events

LENA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Digital Project Manager

Danone Asia Pacific Holdings

Phone: 82281172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place