Patient Centered Postpartum Contraception 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.

Study Overview

• Status: Completed
• Conditions: Contraceptive Usage
• Intervention / Treatment: Behavioral: Patient Centered Postpartum Contraception 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60605
      • University Of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

-Recruitment will occur at local primary care clinics.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prior Method Use	Methods of birth control participants have ever used	Pre-Survey
Number of Pregnancies (Including Current)		Pre-Survey
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic Information	Monthly income	Pre-Survey

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Melissa Gilliam, MD, MPH, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): January 7, 2019
• Study Completion (Actual): January 7, 2019

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Contraception; Post Partum Contraception
• Other Study ID Numbers: IRB17-12541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No