User Experience of a Mobile Application (SMart)

August 14, 2020 updated by: Danone Asia Pacific Holdings Pte, Ltd.

Evaluating the User Experience of a Mobile Application in Recording Primary Caregiver Reported Outcomes of Infants

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Using a questionnaire to collect overall user experience, frequency of usage, feedback of each module in the mobile application

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Primary Caregiver and infant pair
Primary Caregiver and infant who is less than or equal to 12 months old

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall User experience
Time Frame: Day 14
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
User experience (ease of use) - Primary Caregiver
Time Frame: Day 14
Using a questionnaire to assess primary caregiver ease of use (Very Poor to Very Good or Did Not Use) of use of different modules/trackers in the mobile application
Day 14
User experience (frequency of use) - Primary Caregiver
Time Frame: Day 14
Using a questionnaire to assess primary caregiver frequency (Rarely to Always) of use of different modules/trackers in the mobile application
Day 14
User experience (usefulness) - Healthcare Professionals (HCP)
Time Frame: Day 14
Using a questionnaire to assess HCP reported usefulness (not useful at all to very useful) of the data generation by the mobile application
Day 14
User experience (relevance) - Healthcare Professionals (HCP)
Time Frame: Day 14
Using a questionnaire to assess HCP reported relevance (not relevant at all to very relevant) of the data generation by the mobile application
Day 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
User experience (ease of use) - Primary Caregiver from Day 0 to Day 45
Time Frame: Day 0 to Day 45
Using a questionnaire to assess primary caregiver reported user experience of different modules/trackers in the mobile application on a 5-point scale (Very Poor to Very Good) of the mobile application
Day 0 to Day 45
User experience (frequency of use) - Primary Caregiver from Day 0 to Day 45
Time Frame: Day 0 to Day 45
Using a questionnaire to assess primary caregiver reported user frequency of use of different modules/trackers in the mobile application on a 5-point scale (Rarely to Always) of the mobile application
Day 0 to Day 45
User experience (quality of insights) - Primary Caregiver from Day 0 to Day 45
Time Frame: Day 0 to Day 45
Using a questionnaire to collect quality of insights on a 5-point scale (Very Poor to Very Good) to describe primary caregiver reported events in the modules/trackers in the mobile application
Day 0 to Day 45
User experience (weighing scale) - Primary Caregiver from Day 0 to Day 45
Time Frame: Day 0 to Day 45
Using a questionnaire to assess primary caregiver user experience on a 5-point scale (Very Poor to Very Good) for the use of the weighing scale in measuring weight of their infants
Day 0 to Day 45
User feedback (weighing scale) - Primary Caregiver from Day 0 to Day 45
Time Frame: Day 0 to Day 45
Using an open-ended question to collect primary caregiver feedback for the use of the weighing scale in measuring weight of their infants
Day 0 to Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danone Asia Pacific Holdings Pte, Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Poh Choo Khoo, MBBS, KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBB19GC27359

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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