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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Covid-19 Condition
• Intervention / Treatment: Behavioral: Multiprofessional, tailored rehabilitation

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Recruiting
    • Helsinki University Hospital
    • Contact: Helena Liira, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	0, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Estimate): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Post Covid-19 condition; long Covid
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Disease
• Other Study ID Numbers: HUS/97/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We have applied for EU Horizon funding and potentially share data in that project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No