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Usability and Satisfaction With an Electronic Survey Administration Application in General Population (CePRO)

2019年9月26日 更新者:Ramya Sita Palacholla, MD, MPH、Massachusetts General Hospital
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.

調査の概要

状態

わからない

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Partners HealthCare

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Usability of e-PRO vs. emailed link: survey
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Survey response rate e-PRO vs emailed link
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

協力者

捜査官

  • 主任研究者:Ramya S Palacholla, MD, MPH、Partners HealthCare

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2019年10月1日

一次修了 (予想される)

2020年1月30日

研究の完了 (予想される)

2020年2月28日

試験登録日

最初に提出

2019年9月23日

QC基準を満たした最初の提出物

2019年9月24日

最初の投稿 (実際)

2019年9月25日

学習記録の更新

投稿された最後の更新 (実際)

2019年9月30日

QC基準を満たした最後の更新が送信されました

2019年9月26日

最終確認日

2019年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2019P002811

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

There is not a plan to make IPD available.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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