User Experience of Mobile ApplicationSMartNCT04231188
User Experience of a Mobile Application
An observational study of User Experience of Mobile Application, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- User Experience of Mobile Application
- How many people
- 6 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Dec 2019to 26 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants from birth to ≤ 12 months of age and their primary caregiver
Who may be able to join
- 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
Who cannot join
- Incapability of the primary caregiver to access the mobile application using a smartphone or tablet with internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
Using a questionnaire to collect overall user experience, frequency of usage, feedback of each module in the mobile application
- Conditions
- User Experience of Mobile Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Caregiver and infant pair | Primary Caregiver and infant who is less than or equal to 12 months old |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 14
Secondary outcomes (4)
User experience (ease of use) - Primary Caregiver
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
Measured: Day 14
User experience (frequency of use) - Primary Caregiver
Using a questionnaire to assess primary caregiver frequency (Rarely to Always) of use of different modules/trackers in the mobile application
Measured: Day 14
User experience (usefulness) - Healthcare Professionals (HCP)
Using a questionnaire to assess HCP reported usefulness (not useful at all to very useful) of the data generation by the mobile application
Measured: Day 14
User experience (relevance) - Healthcare Professionals (HCP)
Using a questionnaire to assess HCP reported relevance (not relevant at all to very relevant) of the data generation by the mobile application
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start26 Dec 2019
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Why it stopped: Delay in recruitment due to covid and a newer version of mobile app is available for testing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for User Experience of Mobile ApplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Poh Choo Khoo, MBBS, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231188
- Sponsor's protocol ID
- EBB19GC27359
- Acronym
- SMart
- Status last verified
- Aug 2020
- First submitted
- 6 Dec 2019
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the User Experience of a Mobile Application in Recording Primary Caregiver Reported Outcomes of Infants
- ClinicalTrials.gov ID
- NCT04231188
- Acronym / sponsor ID
- SMart / EBB19GC27359
- Conditions
- User Experience of Mobile Application
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Delay in recruitment due to covid and a newer version of mobile app is available for testing.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Using a questionnaire to collect overall user experience, frequency of usage, feedback of each module in the mobile application
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Caregiver and infant pair | – | –Primary Caregiver and infant who is less than or equal to 12 months old |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants from birth to ≤ 12 months of age and their primary caregiver
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Incapability of the primary caregiver to access the mobile application using a smartphone or tablet with internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
User experience (ease of use) - Primary Caregiver
Time frame: Day 14
User experience (frequency of use) - Primary Caregiver
Time frame: Day 14
User experience (usefulness) - Healthcare Professionals (HCP)
Time frame: Day 14
User experience (relevance) - Healthcare Professionals (HCP)
Time frame: Day 14
Results and safety
The study was stopped early (reason given: Delay in recruitment due to covid and a newer version of mobile app is available for testing.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poh Choo Khoo, MBBS principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of User Experience of Mobile Application, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Delay in recruitment due to covid and a newer version of mobile app is available for testing.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall User experience (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.