- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04102384
Usability and Satisfaction With an Electronic Survey Administration Application in General Population (CePRO)
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Partners HealthCare
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: 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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Usability of e-PRO vs. emailed link: survey
기간: At close-out
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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.
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At close-out
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Survey response rate e-PRO vs emailed link
기간: At close-out
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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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At close-out
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Ramya S Palacholla, MD, MPH, Partners HealthCare
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2019P002811
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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