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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Centered Postpartum Contraception App | Behavioral | This is a theory-based smart phone-based application designed to provide immediate postpartum contraception information to young women aged 15-25. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Prior Method Use | Methods of birth control participants have ever used | Pre-Survey |
| Number of Pregnancies (Including Current) | Pre-Survey |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic Information | Monthly income | Pre-Survey |
Inclusion Criteria:
Exclusion Criteria:
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-Recruitment will occur at local primary care clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Gilliam, MD, MPH | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60605 | United States |
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All enrolled participants were assigned to the single intervention group.
All recruitment was performed in clinic waiting rooms from May 2018-January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Intervention Group | This is a single-arm pre-post study. The intervention group received the app intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Intervention Group | This is a single-arm pre-post study. The intervention group received the app intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test. | Posted | Mean | Standard Deviation | units on a scale | Immediately post intervention |
|
Duration of participation in the study (average 30 minutes per participant).
This is a health education intervention and as such no adverse medical events were anticipated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Intervention Group | This is a single-arm pre-post study. The intervention group received the app intervention. |
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Difficulty with recruiting eligible participants from clinic waiting rooms led to lower enrollment numbers than initially planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen McCammon | Ci3 at the University of Chicago | 773-834-8462 | emccammon@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2018 | May 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| Contraception Knowledge | 7 questions assessing participant knowledge of different contraception methods | Pre-Survey |
| 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. | Pre-Survey, immediately post intervention |
| 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. | immediately post intervention |
| Number of Children | Pre-Survey |
| Number of Induced Abortions | Previous miscarriages, abortions, times pregnant and children participants have | Pre-Survey |
| Number of Miscarriages | Previous miscarriages, abortions, times pregnant and children participants have | Pre-Survey |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Prior Method Use | Methods of birth control participants have ever used | Posted | Number | participants | Pre-Survey |
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| Secondary | Number of Pregnancies (Including Current) | Posted | Median | Full Range | events | Pre-Survey |
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| Secondary | Contraception Knowledge | 7 questions assessing participant knowledge of different contraception methods | Posted | Mean | Standard Deviation | correct answers | Pre-Survey |
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| 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. | One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test. | Posted | Median | Standard Deviation | score on a scale | Pre-Survey, immediately post intervention |
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| 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. | One individual of the 20 total participants completed the pre-test and received the intervention but did not complete the post-test. | Posted | Median | Standard Deviation | score on a scale | immediately post intervention |
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| Secondary | Number of Children | Posted | Median | Full Range | Children | Pre-Survey |
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| Secondary | Number of Induced Abortions | Previous miscarriages, abortions, times pregnant and children participants have | Posted | Median | Full Range | Abortions | Pre-Survey |
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| Secondary | Number of Miscarriages | Previous miscarriages, abortions, times pregnant and children participants have | Posted | Median | Full Range | Miscarriages | Pre-Survey |
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| Other Pre-specified | Sociodemographic Information | Monthly income | Posted | Count of Participants | Participants | Pre-Survey |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| Title | Measurements |
|---|---|
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| Motivation posttest |
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| Behavior pretest |
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| Behavior posttest |
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| .07 |
| Superiority |
| Behavior pre and post paired comparison | Wilcoxon (Mann-Whitney) | .230 | Superiority |