跳至主要内容
临床试验/NCT05781893
NCT05781893已完成不适用

BALCoS - Basel Long COVID Cohort Study and DiLCoS - Digital Long COVID Substudy

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2023年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
196
试验地点
1
主要终点
Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version)

研究概览

简要总结

The Basel Long COVID Cohort Study (BALCoS) is a registry-based cohort study that focuses on the patients' present health status, symptoms, the course of these symptoms, and potential mechanisms involved. The project aims to investigate proposed mechanisms behind Post COVID-19 condition (PCC), including a) autoimmunity, b) chronic inflammation, c) genetics, d) coagulation disorders, and e) psychosocial factors. Patients in the cohort can also join the Digital Long COVID Study (DiLCoS), a single-arm, cohort-based proof-of-feasibility study that is part of the larger BALCoS. DiLCoS is a intervention substudy designed to evaluate whether doing exercises delivered via a smartphone app (referred as digital intervention) can help with PCC. The digital intervention is a 12-week program that includes different kinds of exercises like breathing exercises, relaxation techniques, and tips on managing fatigue and other symptoms. It also teaches patients how to monitor their activities and energy levels, and provides psychological exercises to cope with negative thoughts and pain. Patients in the cohort complete a set of assessments that include the collection of sociodemographic and clinical data, biomarkers, neurocognitive testing, psychometric questionnaires, and measures of physical performance, and provide consent that their data from routine clinical care can be used for the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with PCC will be included. PCC will be defined as:
  • History of confirmed or suspected SARS CoV-2 infection
  • Symptoms usually start within 3 months from the onset of acute SARS CoV-2 infection with symptoms and effects that last for at least 2 months
  • Symptoms cannot be explained by an alternative diagnosis
  • signed informed consent is required
  • Additional Inclusion Criteria for participtation in DiLCoS:
  • A smartphone with a compartible-operating system
  • Separate signed informed consent is required

排除标准

  • Age <18 years
  • Lack of consent to participate in the study
  • Language barriers (lack of sufficient knowledge of German)
  • Lack of general understanding of study procedures

研究组 & 干预措施

BALCoS w/ DiLCoS

Patients of the cohort that are additionnaly enrolled in the DiLCoS substudy

干预措施: Digital intervention (DiLCoS) (Other)

BALCoS w/o DiLCoS

Patients of the cohort that are not enrolled in the DiLCoS substudy

干预措施: Data collection (Other)

BALCoS w/ DiLCoS

Patients of the cohort that are additionnaly enrolled in the DiLCoS substudy

干预措施: Data collection (Other)

结局指标

主要结局

Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12- item version)

时间窗: At Baseline, T1 (BL + 3 months), T2 (BL + 6 months); T3 (BL + 12 months)

The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assesses and classifies disability due to health problems during the past 4 weeks. This study will utilize the 12- item version. Items are answered on a 5-point scale ranging from 0 = "none" to 4 = "extreme or cannot do".

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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