SurveysCePRONCT04102384
Usability and Satisfaction With an Electronic Survey Administration Application in General Population
A study testing e-PRO App in people with Surveys and Usability, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- e-PRO App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners Healthcare
Boston, Massachusetts, 02114
Ramya S Palacholla, M.D, M.P.H, 617-724-0428, RPALACHOLLA@mgh.harvard.edu
Amanda J Centi, P.h.D, 617-724-2158, ACENTI@PARTNERS.ORG
About this study
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.
Read the 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.
- Being tested
- e-PRO App
- Keywords
- Electronic Patient Reported Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-PRO AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: e-PRO App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At close-out
Secondary outcomes (1)
Survey response rate e-PRO vs emailed link
Response rate will be tracked on a weekly basis from the e-PRO system and the REDCap embedded email link to compare response rate between the control and intervention group. The AAOPR (2006) recommendation for RR formula will be used to calculate the RR. This is the number of completed surveys (completed and partially completed) divided by the number of completed surveys (completed and partially completed) plus the number of all non-completed surveys (sent to a potential participant but not completed because of incorrect e-mail address, incorrect mailing address, or other reasons).
Measured: At close-out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Jan 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurveysStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cenduit LLC
- Responsible party
- Principal investigator, Ramya Sita Palacholla, MD, MPH, Massachusetts General Hospital
- Investigators
- Ramya S Palacholla, MD, MPH, Principal investigator, Partners HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102384
- Sponsor's protocol ID
- 2019P002811
- Acronym
- CePRO
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Satisfaction With an Electronic Survey Administration Application in General Population
- ClinicalTrials.gov ID
- NCT04102384
- Acronym / sponsor ID
- CePRO / 2019P002811
- Keywords
- Electronic Patient Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Cenduit LLC
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: e-PRO AppParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-PRO AppThe 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. | Other | Intervention Group |
Primary outcome
Usability of e-PRO vs. emailed link: survey
Time frame: At close-out
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.
1 secondary outcome
Survey response rate e-PRO vs emailed link
Time frame: At close-out
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramya S Palacholla, MD, MPH principal investigator
Partners HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-PRO App in people with Surveys and Usability, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramya S Palacholla, MD, MPH (617-724-0428, RPALACHOLLA@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of e-PRO vs. emailed link: survey (time frame: At close-out). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.