Clinical trial NCT05699512: Functional Ability, Symptoms and Quality of Life in Patients With Post Covid-19 Condition
Official title: What is the Prognosis of Functional Ability, Symptoms and Quality of Life in Patients That Are Treated in a University Hospital Because Symptoms of Post Covid-19 Condition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Covid-19 Condition
Keywords: Post Covid-19 condition
long Covid
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms of long Covid that have lasted at least 3 mo after the primary infection

Brief summary: Up to 20% of patients with Covid-19 develop symptoms that last more than 3 months, which is known as long Covid or Post-Covid-19 condition. The mechanism of the long term symptoms is not totally understood although inflammation, autoimmune reactions and thromboembolism are among suspected contributors. At Helsinki University hospital, a long Covid clinic was opened in June 2021. The aim of this cohort study is to monitor the patients that attend the clinic, follow up their functional abilities, quality of life and prognosis.

Detailed description: The patients are asked to give their informed consent for the participation in the cohort study. They fill in a questionnaire before entering the clinic that assesses their symptoms, previous medical history, medications, lifestyle, symptoms, sleep, psychosocial measures including depression, anxiety, resilience and quality of life.

The patients are asked to give blood samples that rule out other diseases that may cause the symptoms. At the clinic, they attend a physician's consultation with physical exam. Later, in another apppointment, a physicotherapist assesses their physicial functioning including 6 minutes walking test and grip strength. They also attend a psychologist who conducts short, 30 min neuro-cognitive testing.

Patients receive psychoeducation of the Post Covid-19 condition and individual, tailored support and rehabilitation. They are given the opportunity to take part in group counselling once a week during 6 weeks.

The patients are followed up by nurse telephone calls at 3, 6 and 12 months as well as by questionnaires via a secured website.

The main outcome measure in this study is functional ability as measured by WHODAS2.0.

Eligibility criteria: Inclusion Criteria:

* a diagnosed Covid-19 infection at least 3 mo before entry (either PCR positive or antigen test positive or hospitalisation because of Covid-19)

Exclusion Criteria:

* patients for whom participation would be too exhausting, for example bed patients
* patients who cannot fill in the questionnaires in Finnish

Primary outcomes:
measure: Change from baseline of WHODAS2.0 questionnaire as measured at 12 months
timeFrame: 0, 3, 6, and 12 months
Secondary outcomes:
measure: EUROHIS-8 Quality of life
timeFrame: 0, 3, 6, and 12 months
measure: Health related quality of life
timeFrame: 0, 3, 6, and 12 months
measure: Depression
timeFrame: 0, 3, 6, and 12 months
measure: Anxiety
timeFrame: 0, 3, 6, and 12 months
measure: Symptom severity
timeFrame: 0, 3, 6, and 12 months
measure: Resilience
timeFrame: 0, 3, 6, and 12 months
measure: Sleep
timeFrame: 0, 3, 6, and 12 months
measure: SSD-12, somatic symptom disorder
timeFrame: 0, 3, 6, and 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Helena Liira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: