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| Name | Class |
|---|---|
| Cenduit LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-PRO App | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramya S Palacholla, MD, MPH | Contact | 617-724-0428 | RPALACHOLLA@mgh.harvard.edu | |
| Amanda J Centi, P.h.D | Contact | 617-724-2158 | acenti@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Ramya S Palacholla, MD, MPH | Partners HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners Healthcare | Boston | Massachusetts | 02114 | United States |
There is not a plan to make IPD available.
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Intervention- one group will use a smartphone application to fill out surveys while the other group fills out surveys via an emailed embedded link.
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Participants will not know which group (smart phone or embedded link) is the intervention vs. control group.
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| At close-out |