Optimizing Maintenance for Patients With COPD Via a Web Platform - Case Study

COPD Clinical Trial

Official title:

Optimizing Maintenance for Patients With Chronic Obstructive Pulmonary Disease Following Pulmonary Rehabilitation Via a Web Platform - Case Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284865
• Other study ID #: 2020-3607
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pulmonary rehabilitation (PR) has been shown to improve quality of life of people with COPD by decreasing their symptoms. However, the benefits obtained during PR tend to decrease within six months to one year after PR. The objective of this study is to implement a web platform following PR programs in order to improve COPD patients' adherence to self-management techniques. Therefore, the investigators want to verify whether the addition of a tele-management tool allows the gains obtained during PR to be retained over 3, 6 and 12 months. The hypothesis is that participants will maintain their PR gains if they use the platform.

Description:

Introduction: By 2020, chronic obstructive pulmonary disease (COPD) is projected to become the 3rd leading cause of death in the world. Pulmonary rehabilitation (PR) has been shown to improve quality of life of people with COPD by decreasing their symptoms. However, the benefits obtained during PR tend to decrease within six months to one year after PR.

The objective of this study is to implement a web platform following PR programs in order to improve COPD patients' adherence to self-management techniques. Specifically, the investigators will 1) evaluate the adherence to the use of the web platform and 2) the effects on exercise capacity, quality of life, the number of hospitalizations and exacerbations. Therefore, the investigators want to verify whether the addition of a tele-management tool allows the gains obtained during PR to be retained over 3, 6 and 12 months. The hypothesis is that patients will maintain their PR gains if they use the platform.

Methods: Participants with COPD will be selected in a PR group at CHUS Hôtel-Dieu de Sherbrooke. Their initial 10-week rehabilitation program will be followed by the use of a web-based tele-management platform for 12 months. Data will be collected at the beginning of PR (T1), end of the PR (T2), after three months of using the web platform (T3), after six months (Q4) and after 12 months (T5). To measure adherence, the research team will have access to a) the number of connections made on the site, b) the number of exercises performed, c) the duration and type of cardiorespiratory exercises as well as the muscular exercises filled in the logbook and d) the number of exercises performed (breathing, cardiorespiratory and muscular exercises) self-reported by the participants at the time of assessment. For the second objective, the measures used will be FEV1 for lung function, the 6-minutes walk test for exercise capacity, COPD Assessment Test for quality of life, modified BORG scale (0-10) and the medical research center (MRC) for the feeling of dyspnea, the number of hospitalizations over 3, 6 and 12 months (self-reported) and the number of exacerbations via medication taken from their pharmacist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 31, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Complete the PR program at CIUSSSS of Estrie-CHUS in Sherbrooke and finishing after December 2019

• To have a mild to very severe diagnosis of COPD (mild: forced expiratory volume in 1 second (FEV1) ) = 80%, very severe: FEV1 <30% and Tiffeneau score <0.7)

• Have a score =2 on the Medical Research Council (MRC) dyspnea scale

• Have access to a computer, laptop or cell phone at home with an high speed internet service.

Exclusion Criteria:

• Inability to give informed consent

• Instable condition in the 4 weeks prior to the study (change in medication and symptoms such as dyspnea and sputum (colour and quantity)).

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Web Platform
The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.

Locations

Country	Name	City	State
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adherence of each participant	The number of connections made on the site	3 months, 6 months and 12 months
Primary	Change in Adherence of each participant	the number of exercises performed on the platform web	3 months, 6 months and 12 months
Primary	Change in Adherence of each participant	Number of entry/week in the logbook on the platform web	3 months, 6 months and 12 months
Primary	Change in Adherence of each participant	the number of exercises performed (breathing, cardiorespiratory and muscular exercises) self-reported by the participants	3 months, 6 months and 12 months
Secondary	Change in Exercise capacity	six minute walk test (distance reach (m) by walking for 6 minutes)	pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
Secondary	Change of the Quality of life	COPD assessment test (CAT) (measure the impact of COPD on a person's life, and how this changes over time)	pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
Secondary	Change in dyspnea	Borg Scale and the medical research center (MRC) scale (scale of 0 to 10 where 0 is no effort and 10 , maximum effort)	pre-pulmonary rehabilitation, 0 months, 3 months, 6 months and 12 months
Secondary	Change of Number of hospitalizations	Self-reported	pre-pulmonary rehabilitation, 0 months, 6 months and 12 months
Secondary	Change of Number of exacerbations	We will be able to know to number of exacerbations by the medication taken from the pharmacist of each participant	pre-pulmonary rehabilitation, 0 months, 6 months and 12 months