Usability and Satisfaction With an Electronic Survey Administration Application in General Population (CePRO)
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Massachusetts
-
Boston, Massachusetts, Yhdysvallat, 02114
- Partners HealthCare
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Ei väliintuloa: Control Group
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.
|
|
|
Kokeellinen: Intervention Group
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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Usability of e-PRO vs. emailed link: survey
Aikaikkuna: 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.
|
At close-out
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Survey response rate e-PRO vs emailed link
Aikaikkuna: At close-out
|
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).
|
At close-out
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Ramya S Palacholla, MD, MPH, Partners HealthCare
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Odotettu)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 2019P002811
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .