Trial Outcomes & Findings for Enhancing Health Care Access With Cellular Technology (NCT NCT03180138)
NCT ID: NCT03180138
Last Updated: 2018-06-25
Results Overview
Percent of the total number of immunizations received divided by the total number of immunizations required at the time of measurement for each child. Calculated for each child and in each cohort.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
608 participants
Primary outcome timeframe
12 months
Results posted on
2018-06-25
Participant Flow
Participant milestones
| Measure |
Controls
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders Alone
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders + Compliance-linked Incentives
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
|---|---|---|---|
|
Overall Study
STARTED
|
204
|
201
|
203
|
|
Overall Study
COMPLETED
|
182
|
188
|
179
|
|
Overall Study
NOT COMPLETED
|
22
|
13
|
24
|
Reasons for withdrawal
| Measure |
Controls
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders Alone
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders + Compliance-linked Incentives
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
|---|---|---|---|
|
Overall Study
Mobile-phone could not be verified
|
2
|
13
|
15
|
|
Overall Study
No prior immunization records
|
17
|
0
|
6
|
|
Overall Study
Found to be >24 mon after randomization
|
3
|
0
|
3
|
Baseline Characteristics
Enhancing Health Care Access With Cellular Technology
Baseline characteristics by cohort
| Measure |
Controls
n=182 Participants
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders Alone
n=188 Participants
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders + Compliance-linked Incentives
n=179 Participants
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Total
n=549 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
5 Months
n=5 Participants
|
5 Months
n=7 Participants
|
4 Months
n=5 Participants
|
5 Months
n=4 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
282 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
267 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
182 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
549 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPercent of the total number of immunizations received divided by the total number of immunizations required at the time of measurement for each child. Calculated for each child and in each cohort.
Outcome measures
| Measure |
Controls
n=182 Participants
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders Alone
n=188 Participants
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders + Compliance-linked Incentives
n=179 Participants
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
|---|---|---|---|
|
Immunization Rate
|
41.7 Percentage of immunizations
Interval 23.1 to 69.2
|
40.1 Percentage of immunizations
Interval 30.8 to 69.2
|
50.0 Percentage of immunizations
Interval 30.8 to 76.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The events analyzed here are the total number of vaccines rather than subjects in each cohort. The outcome measure is the percent of the number of vaccines that were administrated in a timely manner divided by the total number of scheduled vaccines.
The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.
Outcome measures
| Measure |
Controls
n=243 Vaccines
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders Alone
n=243 Vaccines
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
Reminders + Compliance-linked Incentives
n=287 Vaccines
Reminders alone: Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver).
Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver).
A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
|
|---|---|---|---|
|
Timeliness of Vaccinations
|
31.6 Percentage of vaccines
|
24.7 Percentage of vaccines
|
40.8 Percentage of vaccines
|
Adverse Events
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reminders Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reminders + Compliance-linked Incentives
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