Clinical trial NCT04102384: Usability and Satisfaction With an Electronic Survey Administration Application in General Population
Official title: Usability and Satisfaction With an Electronic Survey Administration Application in General Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surveys
Usability
Healthy
Keywords: Electronic Patient Reported Outcomes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Cenduit LLC
First posted: 2019-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention- one group will use a smartphone application to fill out surveys while the other group fills out surveys via an emailed embedded link.
Primary purpose: OTHER

Brief summary: The goal of the study is to assess the usability and satisfaction of an electronic patient reported outcomes (e-PRO) mobile application. The secondary aim is to assess and compare response rates between two study groups (e-PRO group vs REDCap survey group). A potential differentiating factor between delivering surveys via smart phone and other electronic modes of delivery is the perceived advantage of being able to conveniently complete survey questionnaires at any time and any location. This could help address certain limitations of the quantitative survey method such as recall bias. Furthermore, the portability, connectivity and ubiquity of smartphones may reduce the amount of training or instructions required for users to complete a survey questionnaire on a smartphone.

Detailed description: Patient-reported outcomes (PROs) are vital to understanding the impact of a medical condition and treatment from the participant's perspective. However, the collection of data can be inconsistent in both administration and completion due to the method of delivery. Thus, careful consideration of the data collection mode is needed to ensure the quality of the data. The method of delivery has been shown to have a direct effect on the survey response rates thereby ensuring the validity of the data analyses and results. Previous studies have demonstrated an increase in Web-based survey response rates as compared to paper-based survey response rates. Novel methods of collecting PROs may help to streamline both the process and collection of PROs during clinical trials.

A potential differentiating factor between delivering surveys via smart phone and other electronic modes of delivery is the perceived advantage of being able to conveniently complete survey questionnaires at any time and any location. This could help address certain limitations of the quantitative survey method such as recall bias. Furthermore, the portability, connectivity and ubiquity of smartphones may reduce the amount of training or instructions required for users to complete a survey questionnaire on a smartphone. For researchers, this type of survey delivery method may offer the benefits of a wider target audience and reduce research implementation costs. The e-PRO app is designed to further facilitate the delivery of PRO instruments in a convenient manner to participants. Through its computing capability, and user-friendly interface, the e-PRO app can collect data and implement complex scoring requirements, thus supporting the delivery of self-administered survey questionnaires. The goal of this two-arm randomized controlled pilot is to explore the usability and satisfaction with a novel e-PRO app.

Eligibility criteria: Inclusion Criteria:

* Healthy participants over the age of 18-65 years as assessed by the Self-Rated Health Measure.
* Fluency in English language to be able to read, understand study procedures and complete surveys administered during the study.
* Willing to travel to the downtown Boston area to participate in up to two study visits.
* Willing to participate in the research study and sign informed consent.

Exclusion Criteria:

* Participants with a "fair" or "poor" rating on the Self-Rated Health Measure.
* Participants with EU citizenship or permanent residency
* Participants with severe cognitive, vision, hearing, or speech problems that may prevent them from answering surveys
* Participants with serious psychiatric conditions (moderate or major depressive disorder that may impair their ability to complete surveys
* Participants with any terminal illness (e.g. cancers)
* Patients with implantable devices, pacemakers or body worn electronic medical devices

Primary outcomes:
measure: Usability of e-PRO vs. emailed link: survey
timeFrame: At close-out
Secondary outcomes:
measure: Survey response rate e-PRO vs emailed link
timeFrame: At close-out
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners Healthcare
state: Massachusetts
Study officials:
affiliation: Partners HealthCare
name: Ramya S Palacholla, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: