Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824910
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-03-13
Brief Title:
Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases a Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 groups6 participants each in a Zoom meeting 2 times a week45 min each including 5 min before and 10 min after the meeting for free talk-chat between the participants eg questions perceptions etc The RA will organize the Zoom meetings will resolve general questions eg 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
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 eg 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 groups6 participants each in a Zoom meeting 2 times a week45 min each including 5 min before and 10 min after the meeting for free talk-chat between the participants eg questions perceptions etc The RA will organize the Zoom meetings will resolve general questions eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None