Contraceptive Usage
Conditions
Keywords
Contraception, Post Partum Contraception
Brief summary
This study will evaluate a smart phone-based application (app) designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app.
Detailed description
This study will evaluate a smart phone-based application (app) designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app. Participants will be asked to complete a survey after informed consent and before using the app. After using the app, participants will complete a second survey. This second survey will ask questions about the app including the following topics: Usability, user-friendliness, navigation, user interface, time spent, organization readability; Feasibility, informative, helpful, comprehensible, quality of art, interface, sound; and Acceptability breadth of content, depth of content, engaging and motivating, Innovative utility and value. Women will also rate the degree to which they promote use of the product: would use the app if available, believe the app will support contraceptive use and would recommend the app to peers. Study participation will end once participants are done with the second survey.
Interventions
BEHAVIORALPatient Centered Postpartum Contraception App
This is a theory-based smart phone-based application designed to provide immediate postpartum contraception information to young women aged 15-25.
Sponsors
University of Chicago
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant * Identify as African American or Black * English as primary language
Exclusion criteria
* Not pregnant * Not identifying as African American or Black * Language other than English as primary language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Application | Immediately post intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prior Method Use | Pre-Survey | Methods of birth control participants have ever used |
| Number of Pregnancies (Including Current) | Pre-Survey | — |
| Contraception Knowledge | Pre-Survey | 7 questions assessing participant knowledge of different contraception methods |
| Patient Activation | Pre-Survey, immediately post intervention | 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. |
| Number of Children | Pre-Survey | — |
| Number of Induced Abortions | Pre-Survey | Previous miscarriages, abortions, times pregnant and children participants have |
| Number of Miscarriages | Pre-Survey | Previous miscarriages, abortions, times pregnant and children participants have |
| Information, Motivation and Behavioral Skills | immediately post intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic Information | Pre-Survey | Monthly income |
Countries
United States
Participant flow
Recruitment details
All recruitment was performed in clinic waiting rooms from May 2018-January 2019.
Pre-assignment details
All enrolled participants were assigned to the single intervention group.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Intervention Group This is a single-arm pre-post study. The intervention group received the app intervention. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Arm Intervention Group |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 21.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Feasibility of Application
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.
Time frame: Immediately post intervention
Population: One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Intervention Group | Feasibility of Application | How much do you like the look of the app? | 4.47 units on a scale | Standard Deviation 0.7 |
| Single Arm Intervention Group | Feasibility of Application | How much do you like the app itself? | 4.52 units on a scale | Standard Deviation 0.7 |
| Single Arm Intervention Group | Feasibility of Application | How would you rate the overall quality of this app | 4.16 units on a scale | Standard Deviation 0.96 |
| Single Arm Intervention Group | Feasibility of Application | Likelihood of recommending app to friends | 4.26 units on a scale | Standard Deviation 0.81 |
| Single Arm Intervention Group | Feasibility of Application | Rating the overall quality of the visuals | 3.94 units on a scale | Standard Deviation 1.35 |
| Single Arm Intervention Group | Feasibility of Application | Rating the overall quality of the audio | 4.42 units on a scale | Standard Deviation 1.02 |
| Single Arm Intervention Group | Feasibility of Application | Information discussed was easy to understand | 3.58 units on a scale | Standard Deviation 0.96 |
| Single Arm Intervention Group | Feasibility of Application | Information discussed valuable to my repro health | 3.42 units on a scale | Standard Deviation 1.02 |
| Single Arm Intervention Group | Feasibility of Application | Information helped me learn questions to ask Dr. | 4.32 units on a scale | Standard Deviation 0.95 |
| Single Arm Intervention Group | Feasibility of Application | I think I would need tech support to use this app. | 1.05 units on a scale | Standard Deviation 0.74 |
| Single Arm Intervention Group | Feasibility of Application | I found the various functions were well-integrated | 3.0 units on a scale | Standard Deviation 1.05 |
| Single Arm Intervention Group | Feasibility of Application | Most people would learn to use app quickly. | 3.58 units on a scale | Standard Deviation 0.51 |
| Single Arm Intervention Group | Feasibility of Application | I found the app cumbersome to use. | 2.05 units on a scale | Standard Deviation 1.58 |
| Single Arm Intervention Group | Feasibility of Application | I felt very confident using the app. | 3.42 units on a scale | Standard Deviation 0.69 |
| Single Arm Intervention Group | Feasibility of Application | I needed to learn a lot before I could get going. | 1.16 units on a scale | Standard Deviation 1.21 |
| Single Arm Intervention Group | Feasibility of Application | Rating the overall quality of the videos | 4.32 units on a scale | Standard Deviation 0.95 |
| Single Arm Intervention Group | Feasibility of Application | I will use info provided by the app in the future. | 3.47 units on a scale | Standard Deviation 0.61 |
| Single Arm Intervention Group | Feasibility of Application | I can trust the info in the app. | 3.26 units on a scale | Standard Deviation 0.81 |
| Single Arm Intervention Group | Feasibility of Application | I would like to use this app frequently. | 3.05 units on a scale | Standard Deviation 0.85 |
| Single Arm Intervention Group | Feasibility of Application | I found the app too complex to understand. | 1.05 units on a scale | Standard Deviation 1.31 |
| Single Arm Intervention Group | Feasibility of Application | I thought the app was easy to use. | 3.42 units on a scale | Standard Deviation 0.84 |
| Single Arm Intervention Group | Feasibility of Application | I thought there was too much inconsistency in app. | 1.15 units on a scale | Standard Deviation 0.89 |
Secondary
Contraception Knowledge
7 questions assessing participant knowledge of different contraception methods
Time frame: Pre-Survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Intervention Group | Contraception Knowledge | 3.35 correct answers | Standard Deviation 1.14 |
Secondary
Information, Motivation and Behavioral Skills
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.
Time frame: immediately post intervention
Population: One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Intervention Group | Information, Motivation and Behavioral Skills | Information pretest | 4.0 score on a scale | Standard Deviation 1.69 |
| Single Arm Intervention Group | Information, Motivation and Behavioral Skills | Information posttest | 6.0 score on a scale | Standard Deviation 1.18 |
| Single Arm Intervention Group | Information, Motivation and Behavioral Skills | Motivation pretest | 20.0 score on a scale | Standard Deviation 2.52 |
| Single Arm Intervention Group | Information, Motivation and Behavioral Skills | Motivation posttest | 21.0 score on a scale | Standard Deviation 2.41 |
| Single Arm Intervention Group | Information, Motivation and Behavioral Skills | Behavior pretest | 22.0 score on a scale | Standard Deviation 3.45 |
| Single Arm Intervention Group | Information, Motivation and Behavioral Skills | Behavior posttest | 23.0 score on a scale | Standard Deviation 3.27 |
Comparison: Information pre-post paired comparisonp-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Motivation pre- and post-paired comparison.p-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: Behavior pre and post paired comparisonp-value: 0.23Wilcoxon (Mann-Whitney)
Secondary
Number of Children
Time frame: Pre-Survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm Intervention Group | Number of Children | 1 Children |
Secondary
Number of Induced Abortions
Previous miscarriages, abortions, times pregnant and children participants have
Time frame: Pre-Survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm Intervention Group | Number of Induced Abortions | 0 Abortions |
Secondary
Number of Miscarriages
Previous miscarriages, abortions, times pregnant and children participants have
Time frame: Pre-Survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm Intervention Group | Number of Miscarriages | 0 Miscarriages |
Secondary
Number of Pregnancies (Including Current)
Time frame: Pre-Survey
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm Intervention Group | Number of Pregnancies (Including Current) | 2 events |
Secondary
Patient Activation
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.
Time frame: Pre-Survey, immediately post intervention
Population: One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Intervention Group | Patient Activation | Pre-intervention | 62.0 score on a scale | Standard Deviation 5.68 |
| Single Arm Intervention Group | Patient Activation | Post-intervention | 62.5 score on a scale | Standard Deviation 6.27 |
Comparison: Pre and post-score paired comparison.p-value: 0.383Wilcoxon (Mann-Whitney)
Secondary
Prior Method Use
Methods of birth control participants have ever used
Time frame: Pre-Survey
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Intervention Group | Prior Method Use | Never used a birth control method | 3 participants |
| Single Arm Intervention Group | Prior Method Use | Withdrawal | 6 participants |
| Single Arm Intervention Group | Prior Method Use | Condoms | 11 participants |
| Single Arm Intervention Group | Prior Method Use | Oral contraceptive pill | 6 participants |
| Single Arm Intervention Group | Prior Method Use | Contraceptive injection | 11 participants |
| Single Arm Intervention Group | Prior Method Use | IUD | 0 participants |
| Single Arm Intervention Group | Prior Method Use | Implant | 2 participants |
| Single Arm Intervention Group | Prior Method Use | Contraceptive ring | 1 participants |
| Single Arm Intervention Group | Prior Method Use | Contraceptive patch | 3 participants |
Other Pre-specified
Sociodemographic Information
Monthly income
Time frame: Pre-Survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm Intervention Group | Sociodemographic Information | Less than $500 | 6 Participants |
| Single Arm Intervention Group | Sociodemographic Information | $500-999 | 9 Participants |
| Single Arm Intervention Group | Sociodemographic Information | $1000-2000 | 3 Participants |
| Single Arm Intervention Group | Sociodemographic Information | More than $2000 | 1 Participants |
| Single Arm Intervention Group | Sociodemographic Information | No response | 1 Participants |