Self-management Digital Intervention to Promote Physical Activity in People Living With Chronic Obstructive Pulmonary Disease: a Pilot Randomized Controlled Trial Study Protocol
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Institut et Haute Ecole de la Santé la Source
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility - Time required to complete recruitment
概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •ability to provide informed consent;
- •internet access;
- •ownership of a smartphone or tablet;
- •self-assessed perceived ease of use of digital devices.
排除标准
- •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;
- •f) cognitive impairment diagnosed by the medical team.
结局指标
主要结局
Feasibility - Time required to complete recruitment
时间窗: 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
时间窗: 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
时间窗: From the start of the intervention to study completion, assessed for up to 9 months.
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
时间窗: 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
时间窗: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
Exposure rate to all content available within the mobile application
Acceptability - Consent and retention rates
时间窗: T -1: 1 week before completion of the face-to-face PR program (±72 hours)
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
Acceptability - Acceptance rate of the allocated group
时间窗: T -1: 1 week before completion of the face-to-face PR program (±72 hours)
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.
Acceptability - Rate of participants successfully recruited
时间窗: T0: Within 72 hours after completion of the face-to-face PR program
Acceptability - Intervention acceptance
时间窗: T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week)
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.
次要结局
- Preliminary effectiveness measures - Main variable: number of daily steps(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(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(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(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(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(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(T1: 3 months after the start of the intervention (±1 week) T2: 6 months after the start of the intervention (±1 week))
研究者
Ricardo Salgado
Senior Lecturer UAS
Institut et Haute Ecole de la Santé la Source