Post Covid-19 ConditionLC-cohortNCT05699512
Functional Ability, Symptoms and Quality of Life in Patients With Post Covid-19 Condition
An observational study of Post Covid-19 Condition, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Post Covid-19 Condition
- What is being tested?
- Multiprofessional, tailored rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jul 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with symptoms of long Covid that have lasted at least 3 mo after the primary infection
Who may be able to join
- a diagnosed Covid-19 infection at least 3 mo before entry (either PCR positive or antigen test positive or hospitalisation because of Covid-19)
Who cannot join
- patients for whom participation would be too exhausting, for example bed patients
- patients who cannot fill in the questionnaires in Finnish
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00029
Helena Liira, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Multiprofessional, tailored rehabilitation
- Keywords
- Post Covid-19 condition, long Covid
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiprofessional, tailored rehabilitationBehavioural
Patients receive individual, tailored, multiprofessional rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3, 6, and 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start15 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Covid-19 ConditionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Liira, Helsinki University Central Hospital
- Investigators
- Helena Liira, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699512
- Sponsor's protocol ID
- HUS/97/2021
- Acronym
- LC-cohort
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have applied for EU Horizon funding and potentially share data in that project.
Publications
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.
PubMed 37848295
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05699512
- Acronym / sponsor ID
- LC-cohort / HUS/97/2021
- Conditions
- Post Covid-19 Condition
- Keywords
- Post Covid-19 condition, long Covid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptoms of long Covid that have lasted at least 3 mo after the primary infection
Key inclusion criteria (1 listed)
- a diagnosed Covid-19 infection at least 3 mo before entry (either PCR positive or antigen test positive or hospitalisation because of Covid-19)
Key exclusion criteria (2 listed)
- patients for whom participation would be too exhausting, for example bed patients
- patients who cannot fill in the questionnaires in Finnish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiprofessional, tailored rehabilitationPatients receive individual, tailored, multiprofessional rehabilitation | Behavioural | – |
Primary outcome
Change from baseline of WHODAS2.0 questionnaire as measured at 12 months
Time frame: 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.
8 secondary outcomes
EUROHIS-8 Quality of life
Time frame: 0, 3, 6, and 12 months
Health related quality of life
Time frame: 0, 3, 6, and 12 months
Depression
Time frame: 0, 3, 6, and 12 months
Anxiety
Time frame: 0, 3, 6, and 12 months
Symptom severity
Time frame: 0, 3, 6, and 12 months
Resilience
Time frame: 0, 3, 6, and 12 months
Sleep
Time frame: 0, 3, 6, and 12 months
SSD-12, somatic symptom disorder
Time frame: 0, 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 37848295Virrantaus 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.
- Individual participant dataSharing planned: No. We have applied for EU Horizon funding and potentially share data in that project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Liira, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Covid-19 Condition, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Liira, MD, PhD (+358 50 577 1351, helena.liira@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of WHODAS2.0 questionnaire as measured at 12 months (time frame: 0, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05699512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.