Trial Outcomes & Findings for Patient Centered Postpartum Contraception App (NCT NCT03402217)
NCT ID: NCT03402217
Last Updated: 2024-05-03
Results Overview
Feasibility, acceptability and usability of application. Mean of each item is reported. Each item has a possible score of 1-5, 1 = strongly disagree; 5= strongly agree. Higher scores indicate a better results for all items except "I found the app too complex to understand," "I think I would need tech support to use this app," "I thought there was too much inconsistency in app," "I found the app cumbersome to use," and "I needed to learn a lot before I could get going," where a lower score is a better result.
COMPLETED
20 participants
Immediately post intervention
2024-05-03
Participant Flow
All recruitment was performed in clinic waiting rooms from May 2018-January 2019.
All enrolled participants were assigned to the single intervention group.
Participant milestones
| Measure |
Single Arm Intervention Group
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Centered Postpartum Contraception App
Baseline characteristics by cohort
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post interventionPopulation: One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test.
Feasibility, acceptability and usability of application. Mean of each item is reported. Each item has a possible score of 1-5, 1 = strongly disagree; 5= strongly agree. Higher scores indicate a better results for all items except "I found the app too complex to understand," "I think I would need tech support to use this app," "I thought there was too much inconsistency in app," "I found the app cumbersome to use," and "I needed to learn a lot before I could get going," where a lower score is a better result.
Outcome measures
| Measure |
Single Arm Intervention Group
n=19 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Feasibility of Application
How would you rate the overall quality of this app
|
4.16 units on a scale
Standard Deviation .96
|
|
Feasibility of Application
I thought there was too much inconsistency in app.
|
1.15 units on a scale
Standard Deviation .89
|
|
Feasibility of Application
I felt very confident using the app.
|
3.42 units on a scale
Standard Deviation .69
|
|
Feasibility of Application
I needed to learn a lot before I could get going.
|
1.16 units on a scale
Standard Deviation 1.21
|
|
Feasibility of Application
How much do you like the look of the app?
|
4.47 units on a scale
Standard Deviation .70
|
|
Feasibility of Application
How much do you like the app itself?
|
4.52 units on a scale
Standard Deviation .70
|
|
Feasibility of Application
Likelihood of recommending app to friends
|
4.26 units on a scale
Standard Deviation .81
|
|
Feasibility of Application
Rating the overall quality of the visuals
|
3.94 units on a scale
Standard Deviation 1.35
|
|
Feasibility of Application
Rating the overall quality of the audio
|
4.42 units on a scale
Standard Deviation 1.02
|
|
Feasibility of Application
Rating the overall quality of the videos
|
4.32 units on a scale
Standard Deviation .95
|
|
Feasibility of Application
Information discussed was easy to understand
|
3.58 units on a scale
Standard Deviation .96
|
|
Feasibility of Application
Information discussed valuable to my repro health
|
3.42 units on a scale
Standard Deviation 1.02
|
|
Feasibility of Application
Information helped me learn questions to ask Dr.
|
4.32 units on a scale
Standard Deviation .95
|
|
Feasibility of Application
I will use info provided by the app in the future.
|
3.47 units on a scale
Standard Deviation .61
|
|
Feasibility of Application
I can trust the info in the app.
|
3.26 units on a scale
Standard Deviation .81
|
|
Feasibility of Application
I would like to use this app frequently.
|
3.05 units on a scale
Standard Deviation .85
|
|
Feasibility of Application
I found the app too complex to understand.
|
1.05 units on a scale
Standard Deviation 1.31
|
|
Feasibility of Application
I thought the app was easy to use.
|
3.42 units on a scale
Standard Deviation .84
|
|
Feasibility of Application
I think I would need tech support to use this app.
|
1.05 units on a scale
Standard Deviation .74
|
|
Feasibility of Application
I found the various functions were well-integrated
|
3.0 units on a scale
Standard Deviation 1.05
|
|
Feasibility of Application
Most people would learn to use app quickly.
|
3.58 units on a scale
Standard Deviation .51
|
|
Feasibility of Application
I found the app cumbersome to use.
|
2.05 units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Pre-SurveyMethods of birth control participants have ever used
Outcome measures
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Prior Method Use
Never used a birth control method
|
3 participants
|
|
Prior Method Use
Withdrawal
|
6 participants
|
|
Prior Method Use
Implant
|
2 participants
|
|
Prior Method Use
Condoms
|
11 participants
|
|
Prior Method Use
Oral contraceptive pill
|
6 participants
|
|
Prior Method Use
Contraceptive ring
|
1 participants
|
|
Prior Method Use
Contraceptive patch
|
3 participants
|
|
Prior Method Use
Contraceptive injection
|
11 participants
|
|
Prior Method Use
IUD
|
0 participants
|
SECONDARY outcome
Timeframe: Pre-SurveyOutcome measures
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Number of Pregnancies (Including Current)
|
2 events
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Pre-Survey7 questions assessing participant knowledge of different contraception methods
Outcome measures
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Contraception Knowledge
|
3.35 correct answers
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Pre-Survey, immediately post interventionPopulation: One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test.
Participant total of 13 Likert-style questions asking about how active a role they have taken in determining their health care. Measurement presented is the sum of 13 Likert items 1-5 to create a scale score. Possible score range from 13-65, with higher scores indicating more activation.
Outcome measures
| Measure |
Single Arm Intervention Group
n=19 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Patient Activation
Pre-intervention
|
62.0 score on a scale
Standard Deviation 5.68
|
|
Patient Activation
Post-intervention
|
62.5 score on a scale
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: immediately post interventionPopulation: One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test.
15 questions asking participants about the information, motivation, and behavioral skills they possess relating to spacing pregnancies by 18 months or longer, split into information, motivation, and behavioral self-efficacy variables. Three subscales are presented: information subscale, motivation subscale, and behavioral skills subscale. The information scale is the summed correct answers to 7 questions, possible score 0-7. Motivation subscale is the sum of 6 Likert-type items with values from 1-4, for possible scores of 6-24; higher score is better. Behavioral skills subscale is the sum of 5 Likert-type items with values from 1-5, for possible subscales scores of 5-25; higher score is better.
Outcome measures
| Measure |
Single Arm Intervention Group
n=19 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Information, Motivation and Behavioral Skills
Information pretest
|
4.0 score on a scale
Standard Deviation 1.69
|
|
Information, Motivation and Behavioral Skills
Information posttest
|
6.0 score on a scale
Standard Deviation 1.18
|
|
Information, Motivation and Behavioral Skills
Motivation pretest
|
20.0 score on a scale
Standard Deviation 2.52
|
|
Information, Motivation and Behavioral Skills
Motivation posttest
|
21.0 score on a scale
Standard Deviation 2.41
|
|
Information, Motivation and Behavioral Skills
Behavior pretest
|
22.0 score on a scale
Standard Deviation 3.45
|
|
Information, Motivation and Behavioral Skills
Behavior posttest
|
23.0 score on a scale
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Pre-SurveyOutcome measures
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Number of Children
|
1 Children
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Pre-SurveyPrevious miscarriages, abortions, times pregnant and children participants have
Outcome measures
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Number of Induced Abortions
|
0 Abortions
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Pre-SurveyPrevious miscarriages, abortions, times pregnant and children participants have
Outcome measures
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Number of Miscarriages
|
0 Miscarriages
Interval 0.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-SurveyMonthly income
Outcome measures
| Measure |
Single Arm Intervention Group
n=20 Participants
This is a single-arm pre-post study. The intervention group received the app intervention.
|
|---|---|
|
Sociodemographic Information
Less than $500
|
6 Participants
|
|
Sociodemographic Information
$500-999
|
9 Participants
|
|
Sociodemographic Information
$1000-2000
|
3 Participants
|
|
Sociodemographic Information
More than $2000
|
1 Participants
|
|
Sociodemographic Information
No response
|
1 Participants
|
Adverse Events
Single Arm Intervention Group
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