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

Recruiting

• Conditions: Post Covid-19 Condition

• Registration Number: NCT05699512
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2021-07-15
• Study First Submitted: 2022-01-24
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline of WHODAS2.0 questionnaire as measured at 12 months	0, 3, 6, and 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.

Secondary Outcome Measures

Name	Time	Method
Anxiety	0, 3, 6, and 12 months	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.
Sleep	0, 3, 6, and 12 months	ISI (Insomnia Severity Index) has seven questions. The minimum value is 0 and the maximum value is 28. Higher score means more severe insomnia.
EUROHIS-8 Quality of life	0, 3, 6, and 12 months	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.
Depression	0, 3, 6, and 12 months	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.
Health related quality of life	0, 3, 6, and 12 months	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.
Symptom severity	0, 3, 6, and 12 months	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.
Resilience	0, 3, 6, and 12 months	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.
SSD-12, somatic symptom disorder	0, 3, 6, and 12 months	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.

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland