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Evaluation of a Mobile Application to Facilitate the Interpretation of Spirometry by Family Physicians and Residents

2020年10月8日 更新者:Louis-Philippe Boulet、Laval University

Evaluation of a Mobile Application to Facilitate the Interpretation of the Spirometry Test by Family Physicians and Family Medicine Residents: Impact on Prescription and Interpretation of This Test

Problematic: Spirometry is used to objectify the obstructive syndrome defining chronic obstructive pulmonary disease (COPD). However, this test remains underused in the primary care. The tools available for its interpretation are little used and the existence of several decision algorithms can create confusion during the diagnosis.

Principal objective: To evaluate the impact of a mobile application (SPIRO©) on medical practice (interpretation and prescription of spirometry) of family physicians and family medicine residents working in family medicine units (FMU) in Quebec affiliated with Laval University.

Secondary objective : To evaluate the usability of SPIRO© among family physicians and residents in family medicine working in FMU in Quebec affiliated with Laval University.

Methods: This is a pre-post clinical trial with control group. Participants (family MD and family medicine residents) will be recruited from the various FMU affiliated with Laval University. Participants working in the FMU in the experimental group will be able to use the SPIRO® mobile application to facilitate interpretation of the spirometry test results while participants in the control group will not have access to it during the study. The basic characteristics of the participants and various behavioral parameters based on the theory of planned behavior concerning the interpretation and prescription of spirometry test will be measured. Data from the control group will be collected before those in the experimental group at the time the application is not yet available, which will minimize contamination between groups. The data will be collected with questionnaires delivered in person to the participants before the intervention (T0 time) and then four months later (T1 time) during their team or research meeting. Participants will be recruited in eight of the 12 Quebec FMU affiliated with Laval University, who will be randomly assigned to two equal groups: control and experimental. The intervention will consist in sending the SPIRO© mobile application to participants in the experimental group who will use it for a period of four months.

調査の概要

詳細な説明

Hypothesis : The investigators hypothesize that the use of the SPIRO© application will increase the skills and confidence of family physicians and family medicine residents in prescribing and interpreting spirometry compared to the control group.

The project will be conducted in the following six major steps: 1) Collection of socio-demographic and behavioral characteristics of participants using sections A, B, C and D of the NAPI questionnaire in the control group; 2) Intervention in the control group (they will continue their daily medical practice without being subject to any intervention by our research team), for a period of 4 months; 3) Measurement of behavioral changes in the control group using Sections B, C, D and E of the NAPI questionnaire 4 months after the start of the study; 4) Collection of socio-demographic and behavioral data from participants in the experimental group using sections A, B, C and D of the NAPI questionnaire; 5) E-mail distribution of the application and use of the application by participants in the experimental group for a period of four months, 6) Measurement of behavioral changes in the experimental group after the use of the application, Using sections B, C, D and E of the NAPI questionnaire as well as a questionnaire on the application SPIRO© (SPIRO questionnaire) which will evaluate the usability of this one.

The study has been approved by the research ethic board of the Health and Social Services Center of the old capital - attached to the Integrated Center for Health and Social Services of the National Capital.

研究の種類

観察的

入学 (実際)

104

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

    • Quebec
      • Baie-Comeau、Quebec、カナダ、G4Z 3B8
        • UMF de Manicouagan
      • Gaspé、Quebec、カナダ、G4X 2W2
        • UMF de Gaspé
      • Lac-Etchemin、Quebec、カナダ、G0R 1S0
        • UMF des Etchemins
      • Lévis、Quebec、カナダ、G6W 0J4
        • UMF de Lévis
      • Quebec City、Quebec、カナダ、G1J 2G1
        • Unité de médecine familiale - GMF Maizerets
      • Quebec City、Quebec、カナダ、G1L 3L5
        • UMF Saint-François d'Assise
      • Quebec City、Quebec、カナダ、G1V 0B7
        • Unité de médecine familiale Laval
      • Trois-Pistoles、Quebec、カナダ、G0L 4K0
        • UMF de Trois-Pistoles

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年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Primary care physicians and residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.

説明

Inclusion Criteria:

  • Participants need to be primary care physicians or residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.

Exclusion Criteria:

  • Health professionals not practicing family medicine and residents of other specialties will not be eligible. Individuals who participated in the development of the " subjective Norms, Attitudes, Perceived behavioral control, Intentions (NAPI) " questionnaires (apparent validation) will be excluded.

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

  • 観測モデル:コホート
  • 時間の展望:見込みのある

コホートと介入

グループ/コホート
介入・治療
Control Group
Primary care physicians and residents in family medicine of family medicine units affiliated with Laval University.
Experimental Group
Primary care physicians and residents in family medicine of family medicine units affiliated with Laval University that will use the mobile application SPIRO(c) for a period of four months.
Participants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months.

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
Beliefs about capabilities - interpretation
時間枠:six weeks
The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Beliefs about consequences - prescription
時間枠:six weeks
The beliefs about the consequences of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Beliefs about consequences - interpretation
時間枠:six weeks
The beliefs about the consequences of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Beliefs about consequences - use of a mobile application
時間枠:six weeks
The beliefs about the consequences of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
six weeks
Moral norms - prescription
時間枠:six weeks
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Moral norms - interpretation
時間枠:six weeks
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Moral norms - use of a mobile application
時間枠:six weeks
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
six weeks
Intentions - prescription
時間枠:six weeks
The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Intentions - interpretation
時間枠:six weeks
The beliefs about the intentions of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Intentions - use of a mobile application
時間枠:six weeks
The beliefs about the intentions of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
six weeks
Social influence - prescription
時間枠:six weeks
The beliefs about the social influence of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Social influence - interpretation
時間枠:six weeks
The beliefs about the social influence of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Social influence - use of a mobile application
時間枠:six weeks
The beliefs about the social influence of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
six weeks
Belief about capabilities - prescription
時間枠:six weeks
The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Belief about capabilities - use of a mobile application
時間枠:six weeks
The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
six weeks

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。

スポンサー

捜査官

  • 主任研究者:Louis-Philippe Boulet, MD、Heart and Lung Institute

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 (実際)

2016年10月1日

一次修了 (実際)

2017年7月7日

研究の完了 (実際)

2017年12月20日

試験登録日

最初に提出

2017年6月26日

QC基準を満たした最初の提出物

2017年6月29日

最初の投稿 (実際)

2017年7月2日

学習記録の更新

投稿された最後の更新 (実際)

2020年10月12日

QC基準を満たした最後の更新が送信されました

2020年10月8日

最終確認日

2020年10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

  • SPIRO-MD Residents

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?

未定

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

COPDの臨床試験

SPIROの臨床試験

3
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