NCT04102384

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

September 23, 2019

Last Update Submit

September 26, 2019

Conditions

Keywords

Electronic Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • Usability of e-PRO vs. emailed link: survey

    A survey will be administered to compare groups on their experiences with the survey-method administration (Investigator developed survey). The following components will be taken into account: acceptability-- participant satisfaction with various aspects of the solution (e.g. content, complexity, comfort, delivery, and credibility). Adoption-- participants' intention to try; perceived barriers and facilitators for uptake. Appropriateness-- participant's perceived relevance to need; suitability to daily patient workflow. Feasibility-- suitability for using daily, weekly etc. This survey is not a scored survey.

    At close-out

Secondary Outcomes (1)

  • Survey response rate e-PRO vs emailed link

    At close-out

Study Arms (2)

Control Group

NO INTERVENTION

Participants will be enrolled for a period of 4 weeks. At baseline, we will collect demographic information on participants. During the study, participants will be asked to fill out daily and weekly surveys using an electronically link sent via email. Additionally, participants will be asked to fill out one survey once a week during the study period.

Intervention Group

EXPERIMENTAL

Participants will be enrolled for a period of 4 weeks. At baseline, we will collect demographic information on participants. During the study, participants will be asked to fill out daily and weekly surveys using the e-PRO app. Additionally, participants will be asked to fill out one survey once a week during the study period. A subgroup of these participants will be asked to complete an additional interview to collect more information on their experiences using the mobile app.

Other: e-PRO App

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partners Healthcare

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Ramya S Palacholla, MD, MPH

    Partners HealthCare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramya S Palacholla, MD, MPH

CONTACT

Amanda J Centi, P.h.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know which group (smart phone or embedded link) is the intervention vs. control group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Intervention- one group will use a smartphone application to fill out surveys while the other group fills out surveys via an emailed embedded link.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Partners Healthcare

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

October 1, 2019

Primary Completion

January 30, 2020

Study Completion

February 28, 2020

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations