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

NCT05699512 | Unknown

• 1 other identifier: HUS/97/2021
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Covid-19 Condition

Keywords

Post Covid-19 condition; long Covid

Outcome Measures

Primary Outcomes (1)

• 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.

  0, 3, 6, and 12 months

Secondary Outcomes (8)

• EUROHIS-8 Quality of life

  0, 3, 6, and 12 months

• Health related quality of life

  0, 3, 6, and 12 months

• Depression

  0, 3, 6, and 12 months

• Anxiety

  0, 3, 6, and 12 months

• Symptom severity

  0, 3, 6, and 12 months

Interventions

Multiprofessional, tailored rehabilitation BEHAVIORAL

Patients receive individual, tailored, multiprofessional rehabilitation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms of long Covid that have lasted at least 3 mo after the primary infection

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 37848295 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

CRP, blood count, sedimentation rate, GT, krea, TSH, fasting glucose, ECG, Alat, Afos, K, Na, Ca, Alb, preAlb, B12-TC, cortisole

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena Liira, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Liira, MD, PhD

CONTACT

+358 50 577 1351; helena.liira@hus.fi

Jari Arokoski, Prof

CONTACT

+358 50 428 7901; jari.arokoski@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: January 26, 2023
• Study Start: July 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)