The aim of this study is to set up a registry and to systematically study the long-term out-comes of patients with COVID-19 who survived hospitalization in the Rotterdam Rijnmond area, by recording data from usual care and collecting additional data…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters include physical, cognitive, and psychological
functioning in the long term.
Secondary outcome
Secundary outcomes include health-related quality of life, social
participation, health care paths, and patient satisfaction.
Background summary
The world is overwhelmed by COVID-19, a new respiratory infectious disease.
This new disease and surreal situation are expected to cause severe and
long-lasting physical, cognitive and psychological consequences, affecting
participation and health-related quality of life. After hospitalization, many
patients may need inpatient treatment in a rehabilitation or geriatric center,
while others may be able to go home with outpatient rehabilitation. Health care
paths and long-term functional outcomes after COVID-19 are not known yet.
Knowledge on the extent and predictors of recovery after hospitalization in
patients with COVID-19 is urgently needed, and will facilitate optimization of
triage and rehabilitation of COVID-19 patients and comparable (future)
infectious diseases.
Study objective
The aim of this study is to set up a registry and to systematically study the
long-term out-comes of patients with COVID-19 who survived hospitalization in
the Rotterdam Rijnmond area, by recording data from usual care and collecting
additional data over a 2 years period.
Specific aims are to study:
1] trajectories and predictors of physical, cognitive and psychological
recovery (primary);
2] effects of physical, cognitive and psychological outcomes on social
participation and health-related quality of life;
3] patient flows, health care utilization, and patient satisfaction with care
paths;
4] effects of diversity (age, sex, socio-economic status, cultural background)
on recovery, health care utilization, and patient satisfaction.
Study design
Multicenter prospective cohort study with a 2-year follow-up period. Data
registration as part of regular care takes place in rehabilitation centers and
nursing homes (at admission and discharge) and during regular out-patient
visits. Additional measurements predominantly concern long-term measurements
after 6, 12, and 24 months post-hospital-discharge. If complaints persist,
follow-up will be extended by means of questionnaires at 36, 48 and 60 months
after hospital discharge.
Study burden and risks
The registry is set up for patients with COVID-19 and is therefore
group-related. Data are copied from patient records and additional measurements
are non-invasive and minimally physically demanding. Completion of
questionnaires and additional measurements require a certain time investment
from patients and might lead to temporary fatigue. Yet, by providing frequent
breaks and a maximum duration of 60-85 minutes per session for the online
questionnaires and a maximum duration of 40-45 minutes for the clinical tests,
we aim to minimize the burden for patients. Participants will gain more insight
in their recovery.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
• COVID-19; based on positive PCR or multidisciplinary team decision based on
symptoms and CT or positive serology
• requiring and surviving hospitalization;
• within 6 months post hospital discharge;
• patient or relative has sufficient knowledge of Dutch or English language.
Exclusion criteria
• age< 18 years;
• incapacitated subjects.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74252.078.20 |
| Other | NL8710 |