Self-management Digital Intervention to Promote Physical Activity in People Living With COPD

N/AActive Not RecruitingNCT07262229

Institut et Haute Ecole de la Santé la Source23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Respir'air BPCOBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. a GOLD COPD diagnosis stage 1 to 4, classification B or E; 2. admitted electively at Hospital for PR; 3. had completed the pulmonary rehabilitation program; 4. age over 18 years; 5. ability to provide informed consent; 6. internet access; 7. ownership of a smartphone or tablet; 8. self-assessed perceived ease of use of digital devices. Exclusion Criteria: 1. clinical instability confirmed by the team of healthcare professionals; 2. severe cardiovascular disease confirmed by medical diagnosis; 3. recent history of neoplasia or autoimmune disease; other physical activity-limiting clinical condition confirmed by medical diagnosis (e.g. neurological disease); 4. other respiratory disease as primary diagnosis; e) inability to read, understand or speak French; f) cognitive impairment diagnosed by the medical team.

Outcomes

Primary Outcomes

Trial methodological feasibility indicator - Time required to complete recruitment

Time frame: T0 - End of face-to-face PR program (Researchers expect to need 3 months to recruit 20 participants.)

Trial methodological feasibility indicator - Consent rate

Consent rate: proportion of eligible participants who sign the informed consent form

Time frame: T0: Within 72 hours after completion of the face-to-face PR program

Trial methodological feasibility indicator - Retention rates

Retention rate: proportion of enrolled participants who remain in the study until the final assessment point

Time frame: T -1: 1 week before completion of the face-to-face PR program (±72 hours)

Trial methodological feasibility indicator - 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.

Time frame: T -1: 1 week before completion of the face-to-face PR program (±72 hours)

Trial methodological feasibility indicator - Proportion of missing data in the completed questionnaires/pedometer

Time frame: 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)

Intervention feasibility indicator - Intervention fidelity

Exposure rate to all content available within the mobile application

Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

Intervention feasibility indicators - Number of technical problems auto reported by the patient

Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

Intervention feasibility indicator - 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

Time frame: From the start of the intervention to study completion, assessed for up to 9 months.

Intervention acceptability indicators - App usage

Daily App Login Status

Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

Intervention acceptability indicators - 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.

Time frame: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)

Secondary Outcomes

Preliminary effectiveness measures - Main variable: number of daily steps

Yamax Power Walker EX-510 pedometer over 5 consecutive days

Time frame: 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: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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)

Self-management Digital Intervention to Promote Physical Activity in People Living With COPD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes