Building a Swiss Pain Registry: A National Framework for Acute and Chronic Pain Assessment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Feasibility of baseline assessment
研究概览
简要总结
The goal of this observational registry is to systematically collect and analyse real-world clinical and patient-reported data in individuals receiving treatment for acute and chronic pain. The main questions it aims to answer are: How do pain intensity, functional status, and quality of life evolve over time in patients with acute and chronic pain? How are different routine clinical treatment approaches associated with patient-reported outcomes in real-world clinical practice? Participants already receiving standard care for pain management will have routine clinical data recorded as part of their treatment and will be asked to complete standardized questionnaires on pain intensity, functional status, and quality of life at multiple time points during treatment and follow-up. Data are collected using a secure electronic system and are pseudonymised prior to analysis in accordance with Swiss data protection regulations.
详细描述
This prospective, observational registry study aims to establish a standardized, multidomain digital assessment platform for patients with acute and chronic pain within routine outpatient care at the University Hospital Bern. The registry is designed as a scalable national infrastructure with planned expansion to additional Swiss pain clinics. The primary objective is to evaluate feasibility, acceptability, and data quality of a digital baseline assessment integrating validated patient-reported outcome measures (PROMs) across pain, functional, psychological, sleep, and quality-of-life domains. Secondary objectives include the description of baseline patient profiles, exploration of longitudinal outcomes at 6, 12, 18, and 24 months, assessment of operational feasibility of follow-up assessments, and investigation of sex- and gender-related differences. In addition, optional treatment-triggered follow-up modules may be used after therapeutic interventions to capture short-term outcomes, side effects, and patient-reported treatment satisfaction. Data are collected prospectively via REDCap and include both routinely documented clinical data and additional patient-reported outcomes. The study duration is 36 months, including a 12-month recruitment phase and 24 months of follow-up per participant.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent by the participant or legal guardian for minors.
- •Diagnosis of acute or chronic pain (chronic pain defined as pain lasting ≥ 3 months), including nociceptive, neuropathic, or mixed pain conditions.
- •Referral for interdisciplinary outpatient pain assessment or treatment.
- •Sufficient proficiency in German, French, Italian, or English to complete digital assessments (parental proxy allowed for paediatric participants if needed).
- •All age groups included.
排除标准
- •Lack of capacity to provide informed consent or absence of a legal guardian for minors.
- •Inability to understand study languages and complete assessments even with assistance.
- •Acute life-threatening conditions precluding participation.
- •Site-specific safety considerations as determined by treating clinician.
结局指标
主要结局
Feasibility of baseline assessment
时间窗: Baseline (at enrollment)
Feasibility is defined as the proportion of eligible participants who complete the full multidomain digital baseline assessment across all predefined domains.
Data quality of baseline assessment
时间窗: Baseline (at enrollment)
Data quality will be evaluated by completeness of core variables of the multidomain digital baseline assessment (percentage of missing data at item and domain level).
次要结局
- Pain intensity(Baseline, 6, 12, 18, 24 months)
- Pain interference(Baseline, 6, 12, 18, 24 months)
- Neuropathic pain screening(Baseline, 6, 12, 18, 24 months)
- Neuropathic pain symptom profile(Baseline, 6, 12, 18, 24 months)
- Functional disability(Baseline, 6, 12, 18, 24 months)
- Work ability(Baseline, 6, 12, 18, 24 months)
- Psychological distress(Baseline, 6, 12, 18, 24 months)
- Pain catastrophizing(Baseline, 6, 12, 18, 24 months)
- Sleep quality(Baseline, 6, 12, 18, 24 months)
- Health-related quality of life(Baseline, 6, 12, 18, 24 months)
- Global patient-reported improvement(6, 12, 18, 24 months)
- Follow-up completion and adherence(6, 12, 18, 24 months)