跳至主要内容
临床试验/NCT06085911
NCT06085911Unknown不适用

Intervention Against Long COVID in Norway - Systematic Rehabilitation. A Randomised Pilot and Feasibility Study.

University Hospital of North Norway1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Symptom reduction

研究概览

简要总结

The Coronavirus 2019 (COVID-19) pandemic has resulted in at least four million infections in Norway. The vast majority of cases are diagnosed and followed up in the community, but some with extensive symptoms and large degree of reduced function are referred to regional Covid-clinics. In total this patient group is placing an enormous burden on the already over stretched health care services. As the pandemic subsides the emerging threat of long-term disability from COVID remains to be quantified. Brain fog and cognitive symptoms are common in long COVID in 30% of mild infections resulting in sick leave and loss of daily function, with women overrepresented among long COVID sufferers. The true prevalence and underlying mechanisms of long COVID remains to be quantified. Although vaccination prevents severe infection and death, we have little knowledge on how best to rehabilitate those who suffers from long COVID.

Here we propose to develop knowledge on treatment interventions to counteract disability from long COVID and lessening the burden on health care services. We will conduct a study of where we compare a short group intervention with systematic personalised neurocognitive rehabilitation to document symptom alleviation. Our overarching goal is to develop effective programmes for this evolving disease to reduce the suffering for the patients, and thereby reducing costs for health services and society at large.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Symptoms attributable to long COVID according to WHO definition [14] that affect their daily activities
  • •Positive Covid test; a home-test, PCR test or serology.
  • •Neurocognitive symptoms
  • •Age between 18 and 65 years
  • •Participant is able and willing to provide informed consent

排除标准

  • •Patients that do not want to comply to planned physical study visits
  • •Patients who are unable to complete surveys in Norwegian
  • •Patients with known chronic neurocognitive disease before Covid-19 or other diseases that can explain current symptoms

研究组 & 干预措施

individual follow-ups

Experimental

tailored individual follow-up rehabilitation program with home-based exercises

干预措施: Individual follow-ups (Behavioral)

a one-day course.

Active Comparator

a one-day course.

干预措施: One day course (Behavioral)

结局指标

主要结局

Symptom reduction

时间窗: 3 months

A reduction in number present symptoms is evaluated in each patient group. A significant greater alleviation in the of number symptoms at three months is considered as a better prognosis.

次要结局

  • Graded symptom reduction(3-12 months)
  • Work improvement(3-12 months)
  • Neuropsychological functions improvement(6 months)
  • Symptoms grouped by systems reduction(12 month follow-up)
  • Quality of life improvement(3-12 months)

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (1)

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