User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study

Preeclampsia Clinical Trial

Official title:

User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384226
• Other study ID #: 14-1173
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2020

Study information

• Verified date: March 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Refine content and delivery of the mHealth delivered lifestyle intervention program through iterative testing with small groups of users who provide feedback through on-line asynchronous focus groups.

Description:

Participants are asked to: - Use mobile app for 4 weeks - Receive support from the lifestyle coach - Provide weekly and ongoing feedback via an online asynchronous user group platform on usability, navigability, acceptability, and satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age 18-45
• Body Mass Index (BMI): 25 - 45 kg/m2
• Positive history of one or more of the following complications in most recent

singleton pregnancy:

1. Gestational diabetes mellitus

2. Preeclampsia (high blood pressure and proteinuria diagnosed after 20 weeks gestation)

3. Gestational hypertension (new hypertension diagnosed after 20 weeks without proteinuria)

4. Pre-term delivery (32-37 weeks)

5. Small for gestational age (<10th percentile for gestational age)

• Able to communicate in English
• Access to and be willing to use a wi-fi enabled iPhone or iPod
• Access to a computer with internet access
• Capable of providing informed consent
• Between 4 weeks and 24 weeks after delivery

Exclusion Criteria:

• Personal history of Type 1 or 2 diabetes
• Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer;
• Personal history of major chronic illness including cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months;
• Underlying disease/treatment that might interfere with participation in/completion of the study (e.g. significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)

Related Conditions & MeSH terms

• Delivery of Small for Gestational Age (SGA) Baby
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Gestational Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Pre-term Delivery
• Preeclampsia

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of the Application	Usability is defined via Young's Mobile Phone Usability Questionnaire (MPUQ) as how easy the app is to use and how easy it is to learn. The investigators will assess components of usability including: 1) learnability (how easy is it to accomplish basic tasks the first time the app is used?); 2) efficiency (once users can use the app, how quickly can they perform tasks?); 3) memorability (if a user returns to an app after not using it for some time, how easy is it to re-establish proficiency?); 4) errors (how many, how severe, how easy to recover?); and 5) satisfaction (how pleasant is it to use the app?).	4 weeks
Primary	Engagement with the Application	The quantitative assessment of the daily use of the mobile application, including the response to prompts, interactions with lifestyle coach, points earned, and tracking of weight, diet, and physical activity.	4 weeks
Secondary	Navigability of the Application	Navigability is defined via Young's Mobile Phone Usability Questionnaire (MPUQ) as whether people can easily and quickly find what they need. The investigators will assess components of navigability including: 1) Is it relatively easy to move from one part of a task to another? 2) Are the operations of this application (app) simple and uncomplicated? 3) Does the app enable the quick, effective, and economical performance of tasks? 4) Is it easy to access the information that you need? 5) Does the app have all the functions and capabilities you expect it to have? 6) Is it easy to navigate between menus and content?	4 weeks
Secondary	Acceptability of the Application	Acceptability is defined whether the intended audience finds the content accessible-meaning that it is written in a way that is easily understood and resonant for this population of postpartum women.	4 weeks