Patient Centered Postpartum Contraception App

Contraceptive Usage Clinical Trial

Official title:

Patient Centered Postpartum Contraception App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402217
• Other study ID #: IRB17-12541
• Status: Completed
• Start date: May 18, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage

Intervention

Behavioral:
• Patient 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.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic Information	Monthly income	Pre-Survey
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.	Immediately post intervention
Secondary	Prior Method Use	Methods of birth control participants have ever used	Pre-Survey
Secondary	Number of Pregnancies (Including Current)		Pre-Survey
Secondary	Contraception Knowledge	7 questions assessing participant knowledge of different contraception methods	Pre-Survey
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.	Pre-Survey, immediately post intervention
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.	immediately post intervention
Secondary	Number of Children		Pre-Survey
Secondary	Number of Induced Abortions	Previous miscarriages, abortions, times pregnant and children participants have	Pre-Survey
Secondary	Number of Miscarriages	Previous miscarriages, abortions, times pregnant and children participants have	Pre-Survey