- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03206606
Evaluation of a Mobile Application to Facilitate the Interpretation of Spirometry by Family Physicians and Residents
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Quebec
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Baie-Comeau, Quebec, 캐나다, G4Z 3B8
- UMF de Manicouagan
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Gaspé, Quebec, 캐나다, G4X 2W2
- UMF de Gaspé
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Lac-Etchemin, Quebec, 캐나다, G0R 1S0
- UMF des Etchemins
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Lévis, Quebec, 캐나다, G6W 0J4
- UMF de Lévis
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Quebec City, Quebec, 캐나다, G1J 2G1
- Unité de médecine familiale - GMF Maizerets
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Quebec City, Quebec, 캐나다, G1L 3L5
- UMF Saint-François d'Assise
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Quebec City, Quebec, 캐나다, G1V 0B7
- Unité de médecine familiale Laval
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Trois-Pistoles, Quebec, 캐나다, G0L 4K0
- UMF de Trois-Pistoles
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Beliefs about capabilities - interpretation
기간: six weeks
|
The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry.
|
six weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Beliefs about consequences - prescription
기간: 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
기간: 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
기간: 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.
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six weeks
|
|
Moral norms - prescription
기간: 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
기간: 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
기간: 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
기간: six weeks
|
The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry.
|
six weeks
|
|
Intentions - interpretation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Louis-Philippe Boulet, MD, Heart and Lung Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- SPIRO-MD Residents
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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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