Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Traditional pulmonologist follow-up, along with physiotherapy sessions | |
| Respir'air BPCO | Experimental | Self-management digital intervention (Respir'air BPCO) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respir'air BPCO | Behavioral | Self-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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Time required to complete recruitment | T0 - End of face-to-face PR program (Researchers expect to need 3 months to recruit 50 participants.) | |
| Feasibility - The amount of missing data in the completed questionnaires | T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) | |
| 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 | From the start of the intervention to study completion, assessed for up to 9 months. |
| Feasibility - Number of technical problems auto reported by the patient | T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) | |
| Feasibility - Intervention fidelity | Exposure rate to all content available within the mobile application | T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| Acceptability - Consent and retention rates | Consent rate: proportion of eligible participants who sign the informed consent form Retention rate: proportion of enrolled participants who remain in the study until the final assessment point | T -1: 1 week before completion of the face-to-face PR program (±72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary effectiveness measures - Main variable: number of daily steps | Yamax Power Walker EX-510 pedometer over 5 consecutive days | T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
f) cognitive impairment diagnosed by the medical team.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Salgado, MSc | Contact | 0041215564334 | r.salgado@ecolelasource.ch | |
| Philippe Delmas, PhD | Contact | p.delmas@ecolelasource.ch |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Salgado, MSc | Institut et Haute Ecole de la Santé la Source | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle de pneumologie de l'Hôpital de Rolle | Rolle | Switzerland |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Acceptability - Acceptance rate of the allocated group | Acceptance rate will be assessed using administrative study records. It will be defined as the proportion of enrolled participants who agree to participate in the group to which they were allocated (control or intervention) immediately after randomization. | T -1: 1 week before completion of the face-to-face PR program (±72 hours) |
| Acceptability - Rate of participants successfully recruited | T0: Within 72 hours after completion of the face-to-face PR program |
| Acceptability - Intervention acceptance | Daily App Login Status | T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| Acceptability - Intervention acceptance | French-adapted version of the Treatment Acceptance and Preference (TAP) questionnaire.Responses are scored on a five-point Likert scale ranging from 0 ("not at all") to 4 ("extremely"), with higher scores reflecting greater acceptance. | T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| 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. |
| T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| 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. | T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| 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 | T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| Preliminary effectiveness measures - secondary variable: severity of dyspnea | French version of the mMRC Dyspnoea Scale. Uses a scale from 0 to 4. A score of 4 represents the highest severity of the dyspnea | T0: Within 72 hours after completion of the face-to-face PR program T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| Preliminary effectiveness measures - secondary variable: number of exacerbations | Self-reported data | T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| Preliminary effectiveness measures - secondary variable: number of hospitalizations | Self-reported data | T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |