Functional Ability, Symptoms and Quality of Life in Patients With Post Covid-19 Condition

NCT ID: NCT05699512

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2024-12-31

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.

Conditions

Post Covid-19 Condition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Multiprofessional, tailored rehabilitation

Patients receive individual, tailored, multiprofessional rehabilitation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Helena Liira

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Liira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Helena Liira, MD, PhD

Role: CONTACT

helena.liira@hus.fi

+358 50 577 1351

Jari Arokoski, Prof

Role: CONTACT

jari.arokoski@hus.fi

+358 50 428 7901

Facility Contacts

Helena Liira, MD, PhD

Role: primary

References

Virrantaus H, Liira H, Posharina T, Sulg A, Mantyla T, Kanerva M, Laakso S, Sainio M, Malmivaara A, Vuokko A, Varonen M, Venalainen M, Arokoski J. Prognosis of patients with long COVID symptoms: a protocol for a longitudinal cohort study at a primary care referred outpatient clinic in Helsinki, Finland. BMJ Open. 2023 Oct 17;13(10):e072935. doi: 10.1136/bmjopen-2023-072935.

Reference Type: DERIVED

PMID: 37848295 (View on PubMed)

Other Identifiers

HUS/97/2021

Identifier Type: -

Identifier Source: org_study_id