The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and preliminary effects of a theory-based self-management digital intervention (Respir'air BPCO) designed to promote physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD) after completion of a pulmonary rehabilitation program.
The main question it aims to answer is:
Is the Respir'air BPCO intervention (mobile app) feasible, acceptable, and preliminarily effective in increasing physical activity, enhancing self-management, improving motivation, and quality of life, while reducing dyspnea severity, exacerbations, and hospitalizations, compared with no additional intervention?
Researchers will compare an experimental group (receiving the Respir'air BPCO intervention + usual care) to a control group (no additional intervention, only usual care)
Participants will:
Be assigned either to the control group, receiving no additional intervention beyond usual care (traditional pulmonologist follow-up), or to the experimental group, receiving access to the Respir'air BPCO mobile app in addition to usual care.
* Complete baseline assessments immediately after finishing their in-person pulmonary rehabilitation program. * Complete follow-up assessments at 3 months and 6 months after the start of the intervention
a GOLD COPD diagnosis stage 1 to 4, classification B or E;
admitted electively at Hospital for PR;
had completed the pulmonary rehabilitation program;
age over 18 years;
clinical instability confirmed by the team of healthcare professionals;
severe cardiovascular disease confirmed by medical diagnosis;
recent history of neoplasia or autoimmune disease; other physical activity-limiting clinical condition confirmed by medical diagnosis (e.g. neurological disease);
other respiratory disease as primary diagnosis; e) inability to read, understand or speak French;
Parallel
Respir'air BPCO
BehavioralSelf-management digital intervention (Respir'air BPCO) grounded in theory (Self-Care Theory of Chronic Illness, Self-Determination Theory of Human Motivation, and the Behavior Change Techniques taxonomy). The mobile application includes educational resources (text, video, images), examples of physical activities (walking, etc), environmental data (air quality), a personal activity log (daily steps), reminders and motivational messages.
Feasibility - Time required to complete recruitment
Feasibility - The amount of missing data in the completed questionnaires
Feasibility - Potential refinements after the completion of the pilot study
A digital logbook for researchers' use, to record any observations or comments (patients and/or researchers perspectives) regarding the intervention design, content and/or usage, with the aim of informing potential refinements after the completion of the pilot study
Feasibility - Number of technical problems auto reported by the patient
Preliminary effectiveness measures - Main variable: number of daily steps
Yamax Power Walker EX-510 pedometer over 5 consecutive days
Preliminary effectiveness measures - secondary variable: Self-management
Self-Care in Chronic Obstructive Pulmonary Disease Inventory (SC-COPDI). Overall standardized scores ranges for each of the three subscales range from 0 to 100. Higher scores indicate higher levels of self-care in COPD patients.
Preliminary effectiveness measures - secondary variable: Motivational regulation of physical activity
French-version of the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3). The score is obtained by averaging responses on a Likert scale ranging from "not at all true" (0) to "very true" (4). Higher scores indicate higher levels of motivation corresponding to the factor being assessed.
Preliminary effectiveness measures - secondary variable: Health-related quality of life
French version of the disease-specific St George's Respiratory Questionnaire. Each item is assigned a weight based on the level of distress attributed to each symptom or condition described. Overall scores range from 0 (no effect on quality of life) to a maximum score of 100 (maximum perceived suffering). A higher score means a poorer quality of life. French version of the EQ-5D-5L questionnaire. Each dimension is rated according to five levels of severity: from "no problem" (0) to "extreme problem" (4). EQ-5D-5L includes a visual analog scale (VAS) that allows participants to rate their general state of health on a scale from 0 to 100. Higher scores correspond to better health-related quality of life
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
