The primary objective is to test the effectiveness of a 12-week personalized interdisciplinary rehabilitation treatment in secondary care to evaluate changes in the recovery of participation levels and quality of life in patients with post-COVID…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study will be participation in society (USER-P) and
health-related quality of life (EQ5D-5L).
Secondary outcome
Secondary outcomes will be daily diary items and validated questionnaires aimed
at physical, mental and cognitive complaints, healthcare- and social costs and
feasibility of the treatment.
Background summary
In the Netherlands, more than 8 million people have been infected with
COVID-19. Most patients with COVID-19 recover fully. However, approximately
10-20% still experience symptoms after recovery from their initial illness.
Post-COVID syndrome is defined as signs and symptoms that develop during or
after an infection consistent with COVID*19, continue for more than 12 weeks
and are not explained by an alternative diagnosis. Symptoms of PCS include
fatigue, shortness of breath, anosmia, muscle aches, headache, chest pain,
palpitations, cognitive dysfunction, anxiety or depression symptoms and sleep
problems. For patients with post-COVID syndrome who have high levels of
disability in daily activities, an interdisciplinary rehabilitation treatment
in secondary care seems indicated. However, the effect of this treatment on
participation in society and quality of life is still unknown.
Study objective
The primary objective is to test the effectiveness of a 12-week personalized
interdisciplinary rehabilitation treatment in secondary care to evaluate
changes in the recovery of participation levels and quality of life in patients
with post-COVID syndrome. The secondary objectives are to test changes in
physical, mental and cognitive functioning and to assess the healthcare- and
social costs (i.e., loss of working hours and incomes) as well as to test the
feasibility of the interdisciplinary rehabilitation treatment.
The hypothesis is that a personalized interdisciplinary rehabilitation
treatment for patients with PCS will improve their participation levels and
QoL, and will decrease physical, mental and cognitive complaints.
Study design
A Replicated and Randomized-Single Case Experimental Design (R-SCED) and a
feasibility study. The study will take place at the rehabilitation department
of Adelante location MUMC+.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: There are no risks involved in this study, but
the time investment might be experienced as a burden. The following
time-consuming activities are being asked of all participants: filling in the
validated questionnaires (45-60 minutes) at 3 time points, filling in the daily
dairies (up to 5 minutes), depending on the randomization 54-60 times, and the
individual semi-structured interview (30 minutes). Benefits of participation in
this study: It is hypothesized that participants will benefit from treatment
program offered. The main benefit of participation in the study is that of
contributing to scientific knowledge and the quality of the interdisciplinary
rehabilitation program.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
To be eligible for participation in this study, patients must meet all the
following criteria:
- COVID-19 symptoms persisting for more than 12 weeks after initial infection
- Experiencing high levels of disability in daily activities and/or
participation due to PCS (rehabilitation physician based).
- Indicated for an interdisciplinary rehabilitation treatment in secondary care
(as decided by a rehabilitation physician).
- Good command of written and spoken Dutch
- Having access to the Internet
- >= 18 years.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Illiteracy / no good knowledge of Dutch
- No access to a smartphone, tablet or computer (or insufficient digital skills)
- Experiencing high levels of disability in daily activities and/or
participation before their COVID-
19 infection
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 | NL83848.068.23 |
Other | Registratienummer volgt |