Clinical trial NCT04771052: Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly
Official title: Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly: the CORE Trial in Response to the Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the COVID unit at CHUS Hôtel-Dieu de Sherbrooke - CIUSSS de L'Estrie - CHUS (CORE program) or CHAUR de Trois-Rivières, CIUSSS de la Mauricie-et-du-Centre-du-Québec (Controls)

Brief summary: Although evidence from the management of other viral respiratory infections suggest that early multidisciplinary rehabilitation could mitigate the adverse effects of the severe form of the illness, and reduce the length of hospital stays (LOS), specific data for COVID-19 are lacking. Hence, in response to the current pandemic, we propose to implement and assess the impact of an early standardized multidisciplinary rehabilitation program tailored to frail older adults on 1) LOS, 2) post-discharge destination, 3) prognostic index and 4) functional capacity.

With a pragmatic multicenter controlled study, the COvid Rehabilitation Program for the Elderly (CORE) trial will allow to measure the effectiveness of a multidisciplinary program to minimize the effects of hospitalization and provide the required tools to rapidly implement an innovative strategy of care for older adults. Indeed, based on the results of this study, and with the support of scientific and professional organizations, a standardized program tailored to older adults with COVID-19 will be disseminated in Canada for all medical units dedicated to the management of the disease. Because of its pragmatic approach, this study will provide a sustainable multidisciplinary intervention that can be quickly implemented in any Canadian (or abroad) COVID-19 medical unit. Finally, given that COVID-19 is the third coronavirus infection in the last 20 years, the expected results will provide guidelines, with decision tree algorithms, for implementation should another coronavirus or for that matter, any other such type of infection that surface in the future.


Eligibility criteria: Inclusion Criteria:

* Patients with medical clearance (physical deconditioning; hemodynamically stable; oxygen therapy by nasal cannula \< 4 L/min for saturation \> 92%; resting respiratory rate \< 24; and heart rate between 50 and 120 beats per minute). Controls were paired with those of the CORE program according to age, sex and pre-admission origin

Exclusion Criteria:

* None

Primary outcomes:
measure: Length of stay
timeFrame: 1 day after discharge
Secondary outcomes:
measure: Post-discharge destination
timeFrame: 1 day after discharge
measure: Readmission rate 30 days after discharge
timeFrame: 30 days after discharge
measure: Change in patient prognosis
timeFrame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
measure: Change in functional capacity (lower limb function)
timeFrame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
measure: Change in functional capacity (handgrip strength)
timeFrame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke (CHUS)
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre hospitalier affilié universitaire régional (CHAUR)
state: Quebec
Study officials:
References: