Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases

COPD Clinical Trial

Official title:

Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824910
• Other study ID #: HS25892 (B2023:030)
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of Manitoba
• Contact: Diana C Sanchez-Ramirez, PhD
• Phone: 12044801346
• Email: diana.sanchez-ramirez[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is being conducted to evaluate the feasibility of using technology to deliver a remote home exercise program and assess the health outcomes of patients with chronic lung diseases. Specific objectives are to assess the interventions on patients: 1) Lung function, 2) Dyspnea, 3) Fatigue, 4) Exercise capacity, 5) Self-efficacy, and 6) Health-related quality of life. The investigators will also be evaluating the practicality of using videoconferencing and commercial wearable telemonitoring devices (ie. smart watches) for the implementation of the intervention in this group of patients.

Description:

This feasibility study uses a one group pre-post intervention study. In a subsequent stage, the possibility of conducting a matched (age, gender, diagnosis) case-control study comparing the effects of this study with the current Pulmonary Rehab WRHA program on patients' outcomes will be explored. Participants who meet the inclusion criteria will be invited to an initial assessment session of approximately 1 hour (week 0) at the RespirabilityLab (Riverview Health Centre - 4th floor of the Princess Elizabeth Building). A registered therapist in charge of implementing the intervention will request informed consent to participate in the study, explain specifics of the intervention to each participant, and will conduct an initial assessment. Using the participants' initial assessment and personal characteristics, the therapists will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), and instruct patients on safety precautions (how to pace themselves, when to seek professional or emergency care). All will receive training in 1) basic device management (join a Zoom meeting, and apps needed), 2) use of a portable spirometer, pulse oximeter and smartwatch, and their associated apps. Two groups of 6 patients will complete an 8-week program (2 rounds of 12 participants for a total of 24 participants in total). The exercise program will involve a small group of peers (2 groups/6 participants each) in a Zoom meeting 2 times a week/45 min each (including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.). The RA will organize the Zoom meetings, will resolve general questions (e.g. equipment, platforms, etc.) and will act as a direct point of contact between the therapist and the participants. An education session (~30-45 min) will be offered to all participants (12 at a given time) once a week over the 8 weeks on key topics such as managing smoking cessation, managing shortness of breath, exercising with chronic lung disease, managing fatigue, etc. Patients will be asked to always wear a smartwatch and a pulse oximeter while exercising so that they can control their pace while avoiding exceeding target values (HR, Sp02). After each exercise session, participants will be asked to open apps on their smartphone or tablet linked to the wearable devices via Bluetooth so that the data can be transmitted to the research team (Labfront dashboard) or emailed to the RA (CVS format). Participants will be able to contact the therapist or the RA at any time during the study if they have questions or concerns. Otherwise, the patients will be contacted if abnormal values are identified in the telemonitoring data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• confirmed diagnosis of COPD or ILD
• living in Manitoba
• Access to smart phone or tablet and home internet service

Exclusion Criteria:

• acute exacerbation of their condition
• history of neurological disease or mental illness
• inability to ambulate independently without supervision
• inability to complete basic tasks on a smart phone or tablet

Related Conditions & MeSH terms

• COPD
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Exercise program (virtual/remote)
Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Medical Service Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lung Function	% predicted FEV1 and FVC will be assessed using a SpiroBank Smart F/V multi parameter spirometer (MIR) at pre-post intervention and once a week in between to monitor changes. This portable spirometer, which is MDSAP approved and complaint with ATS/ ERS guidelines, connects automatically via Bluetooth to an iOS & Android compatible App (MIR Spirobank).	8 weeks
Primary	Change in Dyspnea	Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.	8 weeks
Primary	Change in Fatigue	Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.	8 weeks
Primary	Change in Exercise Capacity	Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).	8 weeks
Primary	Change in Self-efficacy	Assessed using the Self-Efficacy for Managing Chronic Disease 6-Item Scale each rated from 0 "not at all confident" to 10 "totally confident")	8 weeks
Primary	Change in Health Relate quality of life	Assessed with the Clinical COPD Questionnaire (Scored from 0 - 6 [worse])	8 weeks
Primary	Change in Dyspnea severity	Assessed with the modified Medical Research Council (0-4 "higher is worse outcome").	8 weeks
Primary	Impact of cough on quality of life	Assessed with the Leicester Cough Questionnaire (3 - 21 points). Lower scores indicate higher impact of cough on quality of life	8 weeks
Primary	Level of Dysphagia	Assessed with the Sydney Swallow Questionnaire(0-100mm "higher represent worse outcome").	8 weeks
Primary	Change in Health Relate quality of life	Assessed with the St. George's Respiratory Questionnaire. Total score is calculated from 0 (no health impairment) to 100 (maximum health impairment)	8 weeks
Secondary	Participant feedback questionnaire	A questionnaire will be used to capture the participants' level of satisfaction with the study using a 5-points liker scale.	8 weeks