Clinical trial NCT05824910: 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
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Interstitial Lung Disease
Keywords: chronic respiratory diseases
telemonitoring
telerehabilitation
pulmonary rehabilitation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Medical Service Foundation
First posted: 2023-04-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one group pre/post assessment (feasability study)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Lung Function
timeFrame: 8 weeks
measure: Change in Dyspnea
timeFrame: 8 weeks
measure: Change in Fatigue
timeFrame: 8 weeks
measure: Change in Exercise Capacity
timeFrame: 8 weeks
measure: Change in Self-efficacy
timeFrame: 8 weeks
measure: Change in Health Relate quality of life
timeFrame: 8 weeks
measure: Change in Dyspnea severity
timeFrame: 8 weeks
measure: Impact of cough on quality of life
timeFrame: 8 weeks
measure: Level of Dysphagia
timeFrame: 8 weeks
measure: Change in Health Relate quality of life
timeFrame: 8 weeks
Secondary outcomes:
measure: Participant feedback questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Diana C Sanchez-Ramirez, PhD
role: PRINCIPAL_INVESTIGATOR
References: