Évaluation d'Impact de l'Intervention du Breizh Fabribus Pour la création ou l'Adaptation d'Aide Technique personnalisée (BFB-IMPACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in frequency of exposure to the index activity limitation at three months post-intervention
研究概览
简要总结
In France, more than 14 million individuals report severe functional limitations, and nearly 5 million struggle with essential daily activities. Traditional barriers to assistive technology-high costs, lengthy funding delays, lack of information, and poorly fitting off-the-shelf solutions-frequently lead to underuse, dissatisfaction, and environmental waste The BFB-IMPACT study evaluates the real-world effectiveness of Breizh Fabribus, a mobile workshop equipped with 3D printing and laser-cutting that produces and customizes assistive devices on site for people with disabilities in Finistère, France region. This retrospective, single-center investigation includes all service recipients from January 2024 to December 2025 and measures changes in users' ability to perform targeted activities at three months post-intervention. Secondary outcomes include user satisfaction and device utilization. Data collection occurs from October 2025 to May 2026, with analysis anticipated in June 2026 and results published in the second half of 2026.
详细描述
The BFB-IMPACT protocol is a retrospective, mixed-methods study designed to assess Breizh Fabribus's impact on daily functioning and satisfaction among people with disabilities. All individuals who received at least one assistive device from Breizh Fabribus between January 1, 2024, and December 31, 2025, are identified via routine service records. Eligible participants and their caregivers are contacted by phone or mail and provided with study information and a consent form. Upon consent, baseline data-including demographics, medical history, and the nature of the activity difficulty-are extracted from initial request forms.
At the time of device delivery, each participant completes the Client Satisfaction Questionnaire (CSQ-8) to capture immediate feedback on device fit, usability, and co-creation experience. Three months later, participants receive a standardized follow-up questionnaire addressing: frequency of device use; changes in exposure to the originally problematic activity, rated on a five-point ordinal scale; satisfaction with device performance; and open-ended comments on barriers or facilitators. Data collection is conducted via secure online surveys or postal forms, with up to two reminders for nonresponders. An optional twelve-month follow-up is offered within the scheduled data-collection window (October 2025-May 2026) to explore longer-term durability of benefits.
The primary endpoint compares baseline and three-month follow-up scores on the activity exposure scale using paired statistical tests. Secondary analyses include trends in satisfaction scores, logistic regression to identify predictors of device adoption, and inductive content analysis of open-text feedback.
Data collection concludes in May 2026. Analysis is planned for June 2026, followed by manuscript preparation and dissemination to stakeholders in the second half of 2026. Continuous monitoring by the study coordinator ensures protocol adherence, timely follow-up, and resolution of any deviations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any person who has received assistance from BFB for the creation or adaptation of assistive technology
排除标准
- •objection to the use of their data
- •Sollicitation but no delivery of technical assistance by BFB
结局指标
主要结局
Change in frequency of exposure to the index activity limitation at three months post-intervention
时间窗: Three months following delivery of the personalized assistive device.
Change in the frequency with which participants encounter their initial activity limitation, measured via a standardized 5-point ordinal scale at baseline and at three months post-intervention. On this scale, 1 represents "never exposed to the activity limitation" and 5 indicates "exposed every day." Lower scores correspond to less frequent difficulty, while higher scores reflect more frequent difficulty with the targeted activity. This outcome assesses the impact of the personalized assistive device provided by Breizh Fabribus.
次要结局
- Satisfaction with the Assistive Device(At device delivery and three months post-intervention.)
- Frequency of Device Use(Three months post-intervention)
- Barriers to Device Utilization(Three months post-intervention.)
- Influence of Sociodemographic Factors(Three months post-intervention.)
- Reasons for Requesting the Assistive Device(At baseline (device request/intake).)