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Trial Outcomes & Findings for Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations (NCT NCT04496453)

NCT ID: NCT04496453

Last Updated: 2023-04-18

Results Overview

Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure
Childhood Vaccination Decision Support Tool
Participants receive childhood vaccination decision support tool Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool
Overall Study
STARTED
17
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Childhood Vaccination Decision Support Tool
Participants receive childhood vaccination decision support tool Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool
Overall Study
Lost to Follow-up
6

Baseline Characteristics

Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Childhood Vaccination Decision Support Tool
n=17 Participants
Participants receive childhood vaccination decision support tool Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool
Age, Continuous
34.06 years
STANDARD_DEVIATION 7.33 • n=5 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=5 Participants
Race (NIH/OMB)
White
6 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
17 Participants
n=5 Participants

PRIMARY outcome

Timeframe: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

Population: Participants who completed both questionnaires.

Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.

Outcome measures

Outcome measures
Measure
Childhood Vaccination Decision Support Tool
n=11 Participants
Participants receive childhood vaccination decision support tool Childhood vaccination decision support tool: Participants receive childhood vaccination decision support tool
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
1.27 score on a scale
Standard Deviation 1.68

PRIMARY outcome

Timeframe: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

Population: Data not collected.

Outcome measures

Outcome data not reported

Adverse Events

Childhood Vaccination Decision Support Tool

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

Lavanya Vasudevan, Ph.D., M.P.H., C.P.H.

Emory University

Phone: 404-727-3956

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place