NCT04231188

Brief Summary

To evaluate the user experience of the use of the different modules / trackers in the mobile application in recording primary caregiver reported outcomes of infants

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

December 26, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

December 6, 2019

Last Update Submit

August 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall User experience

    Using a questionnaire to assess primary caregiver reported overall experience on a 5-point scale (Very Poor to Very Good) of the mobile application

    Day 14

Secondary Outcomes (4)

  • User experience (ease of use) - Primary Caregiver

    Day 14

  • User experience (frequency of use) - Primary Caregiver

    Day 14

  • User experience (usefulness) - Healthcare Professionals (HCP)

    Day 14

  • User experience (relevance) - Healthcare Professionals (HCP)

    Day 14

Other Outcomes (5)

  • User experience (ease of use) - Primary Caregiver from Day 0 to Day 45

    Day 0 to Day 45

  • User experience (frequency of use) - Primary Caregiver from Day 0 to Day 45

    Day 0 to Day 45

  • User experience (quality of insights) - Primary Caregiver from Day 0 to Day 45

    Day 0 to Day 45

  • +2 more other outcomes

Study Arms (1)

Primary Caregiver and infant pair

Primary Caregiver and infant who is less than or equal to 12 months old

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants from birth to ≤ 12 months of age and their primary caregiver

You may qualify if:

  • Infants from birth to ≤ 12 months of age.
  • Primary caregiver should have access to the internet and a smartphone or tablet to access the mobile application.
  • Primary caregiver should be able to comprehend the content in the mobile application and complete the questionnaires in English.
  • Primary caregiver takes care of the infant more than 50% of the time

You may not qualify if:

  • Incapability of the primary caregiver to access the mobile application using a smartphone or tablet with internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

Study Officials

  • Poh Choo Khoo, MBBS

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2019

First Posted

January 18, 2020

Study Start

December 26, 2019

Primary Completion

June 26, 2020

Study Completion

June 26, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations