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

Primary Purpose

COPD, Interstitial Lung Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise program (virtual/remote)
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring chronic respiratory diseases, telemonitoring, telerehabilitation, pulmonary rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Small group zoom meeting

Arm Description

2 groups of 6 participants will be asked to follow the exercise program with their peers in a zoom meeting 3 times a week for 45 min each time. This time includes 5 min before and 10 min after for free talk and chat between participants. There will also be a weekly zoom education session for 30min.

Outcomes

Primary Outcome Measures

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).
Change in Dyspnea
Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.
Change in Fatigue
Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.
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).
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")
Change in Health Relate quality of life
Assessed with the EQ-5D-5L scale (0-100 higher better outcome).

Secondary Outcome Measures

Participant feedback questionnaire
A questionnaire will be used to capture the participants' level of satisfaction with the study using a 5-points liker scale.

Full Information

First Posted
March 13, 2023
Last Updated
May 1, 2023
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05824910
Brief Title
Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases
Official Title
Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Interstitial Lung Disease
Keywords
chronic respiratory diseases, telemonitoring, telerehabilitation, pulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one group pre/post assessment (feasability study)
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Small group zoom meeting
Arm Type
Experimental
Arm Description
2 groups of 6 participants will be asked to follow the exercise program with their peers in a zoom meeting 3 times a week for 45 min each time. This time includes 5 min before and 10 min after for free talk and chat between participants. There will also be a weekly zoom education session for 30min.
Intervention Type
Other
Intervention Name(s)
Exercise program (virtual/remote)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Lung Function
Description
% 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).
Time Frame
8 weeks
Title
Change in Dyspnea
Description
Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.
Time Frame
8 weeks
Title
Change in Fatigue
Description
Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.
Time Frame
8 weeks
Title
Change in Exercise Capacity
Description
Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).
Time Frame
8 weeks
Title
Change in Self-efficacy
Description
Assessed using the Self-Efficacy for Managing Chronic Disease 6-Item Scale each rated from 0 "not at all confident" to 10 "totally confident")
Time Frame
8 weeks
Title
Change in Health Relate quality of life
Description
Assessed with the EQ-5D-5L scale (0-100 higher better outcome).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Participant feedback questionnaire
Description
A questionnaire will be used to capture the participants' level of satisfaction with the study using a 5-points liker scale.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana C Sanchez-Ramirez, PhD
Phone
12044801346
Email
diana.sanchez-ramirez@umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana C Sanchez-Ramirez, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0T6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana C Sanchez-Ramirez, PhD
Phone
12044801346
Email
diana.sanchez-ramirez@umanitoba.ca

12. IPD Sharing Statement

Learn more about this trial

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

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