An observational study in Post Covid-19 Condition, sponsored by Helsinki University Central Hospital. Status unknown at 1 site in Finland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Helsinki University Central Hospital · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 400 is above the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptoms of long Covid that have lasted at least 3 mo after the primary infection
Exclusion Criteria:
Patients receive individual, tailored, multiprofessional rehabilitation
Change from baseline of WHODAS2.0 questionnaire as measured at 12 months
Functional ability measured by WHODAS2.0 which is a measure developed by WHO and has 36 items. The minimum value is 0, the maximum value is 100. Higher score means worse functional ability.
Time frame: 0, 3, 6, and 12 months
EUROHIS-8 Quality of life
EUROHIS-8 is an 8-item quality of life measure. The minimum value is 1 and the maximum value is 5. Higher score means better quality of life.
Time frame: 0, 3, 6, and 12 months
Health related quality of life
15D is a health related quality of life measure developed in Finland and the main quality indicator of Helsinki University Hospital. Its minimum value is 0 and maximum 1. Higher score means better health related quality of life.
Time frame: 0, 3, 6, and 12 months
Depression
PHQ-9 (Patient Health Questionnaire-9) is a 9-item depression scale. The minimum value is 0 and the maximum is 27. Higher score means more severe depression.
Time frame: 0, 3, 6, and 12 months
Anxiety
GAD-7 (General Anxiety Disorder-7) measures anxiety. The minimum score is 0 and the maximum score is 30. Higher score means more severe anxiety.
Time frame: 0, 3, 6, and 12 months
Symptom severity
PHQ-15 (Patient Health Questionnaire-15) is a somatic symptom subscale that measures somatic symptom (physical) severity. The minimum score is 0 and the maximum score is 30. Higher score means more severe symptom severity.
Time frame: 0, 3, 6, and 12 months
Resilience
Resilience Scale 14 measures the five core characteristics of resilience (purpose, perseverance, self-reliance, equanimity, and authenticity). The minimum value is 0 and the maximum value is 100. Higher score means better resilience.
Time frame: 0, 3, 6, and 12 months
Sleep
ISI (Insomnia Severity Index) has seven questions. The minimum value is 0 and the maximum value is 28. Higher score means more severe insomnia.
Time frame: 0, 3, 6, and 12 months
SSD-12, somatic symptom disorder
SSD-12 (Somatic Symptom Disorder-12) has 12 items. The minimum value 0 and the maximum is 48. Higher score means more severe perceptions related to somatic symptoms.
Time frame: 0, 3, 6, and 12 months
Plan to share: No — We have applied for EU Horizon funding and potentially share data in that project.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital