Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03206606
Other study ID # SPIRO-MD Residents
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2016
Est. completion date December 20, 2017

Study information

Verified date October 2020
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date December 20, 2017
Est. primary completion date July 7, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SPIRO
Participants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months.

Locations

Country Name City State
Canada UMF de Manicouagan Baie-Comeau Quebec
Canada UMF de Gaspé Gaspé Quebec
Canada UMF des Etchemins Lac-Etchemin Quebec
Canada UMF de Lévis Lévis Quebec
Canada UMF Saint-François d'Assise Quebec City Quebec
Canada Unité de médecine familiale - GMF Maizerets Quebec City Quebec
Canada Unité de médecine familiale Laval Quebec City Quebec
Canada UMF de Trois-Pistoles Trois-Pistoles Quebec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beliefs about capabilities - interpretation The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary Beliefs about consequences - prescription The beliefs about the consequences of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Beliefs about consequences - interpretation The beliefs about the consequences of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary Beliefs about consequences - use of a mobile application 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
Secondary Moral norms - prescription The beliefs about the moral norms of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Moral norms - interpretation The beliefs about the moral norms of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary Moral norms - use of a mobile application 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
Secondary Intentions - prescription The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Intentions - interpretation The beliefs about the intentions of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary Intentions - use of a mobile application 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
Secondary Social influence - prescription The beliefs about the social influence of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Social influence - interpretation The beliefs about the social influence of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary Social influence - use of a mobile application 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
Secondary Belief about capabilities - prescription The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Belief about capabilities - use of a mobile application 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06000696 - Healthy at Home Pilot
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04105075 - COPD in Obese Patients
Recruiting NCT05825261 - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting NCT04075331 - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial Phase 2/Phase 3
Terminated NCT03640260 - Respiratory Regulation With Biofeedback in COPD N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn NCT04210050 - Sleep Ventilation for Patients With Advanced Hypercapnic COPD N/A
Terminated NCT03284203 - Feasibility of At-Home Handheld Spirometry N/A
Recruiting NCT06110403 - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness Phase 1/Phase 2
Active, not recruiting NCT06040424 - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Completed NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A
Completed NCT04119856 - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD N/A
Completed NCT04485741 - Strados System at Center of Excellence
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT04860375 - Multidisciplinary Management of Severe COPD N/A