Trial Outcomes & Findings for A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot (NCT NCT03630679)
NCT ID: NCT03630679
Last Updated: 2020-08-13
Results Overview
Obtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot
Recruitment status
COMPLETED
Target enrollment
45 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-08-13
Participant Flow
Participant milestones
| Measure |
Preterm
born at \<37 weeks of gestation
|
Full Term Term
born at \>/= 37 weeks of gestation
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
25
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
7
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Preterm
n=20 Participants
born at \<37 weeks of gestation
|
Full Term Term
n=25 Participants
born at \>/= 37 weeks of gestation
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Parent's age · 21-25 years old
|
2 Participants
n=20 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=45 Participants
|
|
Age, Customized
Parent's age · 26-30 years old
|
3 Participants
n=20 Participants
|
10 Participants
n=25 Participants
|
13 Participants
n=45 Participants
|
|
Age, Customized
Parent's age · 31-35 years old
|
10 Participants
n=20 Participants
|
8 Participants
n=25 Participants
|
18 Participants
n=45 Participants
|
|
Age, Customized
Parent's age · 36-40 years old
|
4 Participants
n=20 Participants
|
6 Participants
n=25 Participants
|
10 Participants
n=45 Participants
|
|
Age, Customized
Parent's age · 41-45 years old
|
1 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
13 Participants
n=25 Participants
|
23 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
12 Participants
n=25 Participants
|
22 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Singapore
|
20 participants
n=20 Participants
|
25 participants
n=25 Participants
|
45 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 8 weeksObtaining number of chats for sleep, stress, and infant nutrition from parents of infants (preterm and full-term) through interaction with the study chatbot
Outcome measures
| Measure |
Preterm
n=20 Participants
born at \<37 weeks of gestation
|
Full Term Term
n=25 Participants
born at \>/= 37 weeks of gestation
|
|---|---|---|
|
Number of Chats on Sleep, Stress and Infant Nutrition
|
131 Chats
|
125 Chats
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Per Protocol
Comparison on ratings for quality of their (parent) sleep from parents of preterm infants and parents of full-term infants
Outcome measures
| Measure |
Preterm
n=13 Participants
born at \<37 weeks of gestation
|
Full Term Term
n=13 Participants
born at \>/= 37 weeks of gestation
|
|---|---|---|
|
Ratings by Parents of Quality of Their Sleep
4 (Very Bad)
|
5 chat responses
|
7 chat responses
|
|
Ratings by Parents of Quality of Their Sleep
1 (Very Good)
|
20 chat responses
|
13 chat responses
|
|
Ratings by Parents of Quality of Their Sleep
2 (Good)
|
42 chat responses
|
48 chat responses
|
|
Ratings by Parents of Quality of Their Sleep
3 (Bad)
|
55 chat responses
|
38 chat responses
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Per Protocol
Comparison of particular reasons for stress caused by the baby from parents of preterm infants and parents of full-term infants
Outcome measures
| Measure |
Preterm
n=13 Participants
born at \<37 weeks of gestation
|
Full Term Term
n=13 Participants
born at \>/= 37 weeks of gestation
|
|---|---|---|
|
Particular Reasons for Stress Caused by the Baby
My baby is crying a lot
|
0 chat responses
|
3 chat responses
|
|
Particular Reasons for Stress Caused by the Baby
My baby is sick
|
4 chat responses
|
0 chat responses
|
|
Particular Reasons for Stress Caused by the Baby
My baby's feeding habits
|
3 chat responses
|
3 chat responses
|
|
Particular Reasons for Stress Caused by the Baby
My baby's growth
|
1 chat responses
|
1 chat responses
|
|
Particular Reasons for Stress Caused by the Baby
My baby's sleeping patterns
|
0 chat responses
|
1 chat responses
|
|
Particular Reasons for Stress Caused by the Baby
Other
|
9 chat responses
|
0 chat responses
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Per Protocol
Comparison of number of chats on the feeding from parents of preterm infants and parents of full-term infants who give their infants formula
Outcome measures
| Measure |
Preterm
n=13 Participants
born at \<37 weeks of gestation
|
Full Term Term
n=13 Participants
born at \>/= 37 weeks of gestation
|
|---|---|---|
|
Number of Chats on Feedings Among Parents Who Give Their Infants Formula
0 to 3
|
19 chat responses
|
13 chat responses
|
|
Number of Chats on Feedings Among Parents Who Give Their Infants Formula
4 to 7
|
30 chat responses
|
19 chat responses
|
|
Number of Chats on Feedings Among Parents Who Give Their Infants Formula
8 to 11
|
22 chat responses
|
13 chat responses
|
|
Number of Chats on Feedings Among Parents Who Give Their Infants Formula
12 and above
|
1 chat responses
|
1 chat responses
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksPopulation: Per Protocol
Satisfaction scale scores for Chatbot and ClaimIt based on a scale score of 1 (very dissatisfied) to 5 (very satisfied) on the Usability of Chatbot and ClaimIt eQuestionnaire
Outcome measures
| Measure |
Preterm
n=13 Participants
born at \<37 weeks of gestation
|
Full Term Term
n=13 Participants
born at \>/= 37 weeks of gestation
|
|---|---|---|
|
Satisfaction Scale Scores for Chatbot and ClaimIt
Chatbot Satisfaction
|
3.62 score on a scale
Standard Deviation 0.96
|
4.0 score on a scale
Standard Deviation 0.82
|
|
Satisfaction Scale Scores for Chatbot and ClaimIt
ClaimIt Satisfaction
|
3.69 score on a scale
Standard Deviation 0.85
|
3.92 score on a scale
Standard Deviation 0.76
|
Adverse Events
Preterm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Full Term Term
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place