To determine whether it is feasible in practice to optimally monitor and treat patients with COVID-19 (Utrecht: CA-ARTI) in the home setting by using an intervention that is widely supported in the region.
ID
Source
Brief title
Condition
- Other condition
- Respiratory tract infections
Synonym
Health condition
COVID-19
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility defined as reaching a stable, regionally supported intervention to
optimally treat patients with (strong suspicion of) COVID-19 (Utrecht:
CA-ARTI)and hypoxemia and/or increased respiratory effort in their home setting
by evaluation in short cycles assessing the care trajectory of 45 patients
within the study
Secondary outcome
- Feeling of safety during the first two weeks of illness as reported by the
patient
- Disability-free survival after 30 days (% change in WHODAS-2 questionnaire
between baseline and day 30)
- Number of days living at home during 30 days follow-up
- Time to discharge from medical follow-up (defined as last contact with
healthcare professional based on EHR)
- Number of GP contacts during 30 days follow-up
- Number of emergency room visits during 30 days follow-up
- Proportion of patients admitted to hospital at 30 days follow-up
- Characteristics of hospitalization within 30 days follow-up
- Mortality at 30 days follow-up
- Cost-benefit analysis
Background summary
The CovidTherapy @ Home project focuses on the development and evaluation of a
regionally supported, safe, feasible and scalable intervention (both medical
and organisational) to optimally monitor and treat patients presenting to
primary care with COVID-19 (Utrecht: CA-ARTI)
Study objective
To determine whether it is feasible in practice to optimally monitor and treat
patients with COVID-19 (Utrecht: CA-ARTI) in the home setting by using an
intervention that is widely supported in the region.
Study design
Action research in which the intervention will be further developed through
short-cycle evaluation rounds by the research team together with an expert
panel by analysing the data collected so far. The initial intervention has been
designed on scientific literature review, practical experience and expert
input. This monocenter, observational pilot study concerns the phase of the
action research in which we will prospectively collect data from 45 patients in
the region to further shape the intervention. A parallel process evaluation
will be performed by conducting semi-structured interviews with patients and
caregivers and relevant health care professionals.
Intervention
A region-wide protocol-based intervention to optimally monitor and treat
patients with (a strong suspicion of) COVID-19 (Utrecht: CA-ARTI) at home. The
intervention consists of intensive home monitoring of vital signs and,
depending on the severity of the disease, addition of treatment with oxygen via
nasal cannula, oral corticosteroids, antibiotics and thrombosis prophylaxis.
Study burden and risks
The intervention encompasses a risk for the first group of patients (category
1) since those patients are not treated in the more controlled setting of the
hospital but in the home setting. To reduce this risk, several prerequisites
and safety nets have been created and described. For category 0 and 2 no a
risks are associated with participation. However, the extra burden consists of
keeping track of and reporting thevital signs **for monitoring purposes.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
Three categories of patients will be included:
Category 0:
Patients with moderate to severe COVID-19 (Utrecht: acute respiratory tract
infections) and co-morbidity, without hypoxemia and/or respiratory distress,
who would normally stay at home without structural monitoring by a regional
monitoring entity.
Category 1:
Patients with COVID-19 (Utrecht: acute respiratory tract infections) and
hypoxemia and/or respiratory distress without signs of clinical instability who
normally would be admitted to a hospital COVID ward for treatment
Category 2:
Patients with (a strong suspicion of) COVID-19 (Utrecht: acute respiratory
tract infections) and hypoxemia and/or respiratory distress for whom
hospitalisation is not considered desirable, but treatment at home is
considered desirable.
Inclusion criteria for category 0:
- Nijmegen Positive SARS-CoV-2 test (PCR or rapid antigen test) with
moderate-severe complaints (>=three days: temperature >=37.5*C; and/or new
complaints of cough, nose cold, sore throat combined with shortness of breath
or combined with fatigue)
- Utrecht: clinical diagnosis of community-acquired acute respiratory tract
infection (CA-ARTI):
-- at least two respiratory symptoms: cough, sore throat, runny nose, nasal
congestion, dyspnea AND
-- at least one systemic symptoms: fever, feverish, chills, fatigue, headache,
myalgia, loss of smell, loss of taste AND
-- clinician judges that symptoms are most likely attributable to CA-ARTI.
- No indication for hospital referral: no hypoximia (measured at rest; SpO2
>94%); no increased respiratory effort (measured at rest; respiratory rate
<24/min); haemodynamically stable (blood pressure > 120/80 mmHg and heart rate
>50/min and <100/min)
- Sufficient proficiency of the Dutch language to provide informed consent (or
translator available to mitigate the language barrier)
- Patient is at risk for complicated disease course (age >70, and/or
immunocompromised, and/or chronic kidney disease, and/or cardiovascular
disease, and/or diabetes mellitus, and/or COPD, and or liver cirrhosis, and/or
obesity (BMI>40)).
Inclusion criteria for category 1:
- Nijmegen Positive SARS-CoV-2 test (PCR or rapid antigen test)
- Utrecht: clinical diagnosis of community-acquired acute respiratory tract
infection (CA-ARTI):
-- at least two respiratory symptoms: cough, sore throat, runny nose, nasal
congestion, dyspnea AND
-- at least one systemic symptoms: fever, feverish, chills, fatigue, headache,
myalgia, loss of smell, loss of taste AND
-- clinician judges that symptoms are most likely attributable to CA-ARTI.
- GP considers referral to hospital because of hypoxemia (SpO2 <94% at rest,
and/or increased respiratory effort with respiratory rate >24/min at rest)
- Haemodynamically stable (blood pressure > 120/80 mmHg and heart rate >50/min
and <100/min)
- Partner/caregiver present at the patient's home for providing supportive care
- Capable of using a pulseoximeter (or caregiver can help)
- Age 18 years or older
- Mentally competent
- Sufficient proficiency of the Dutch language to provide informed consent (or
translator available to mitigate the language barrier)
Inclusion criteria for category 2 :
- Nijmegen Strong suspicion of COVID-19 or positive SARS-CoV-2 test (PCR or
rapid antigen test)
- Utrecht: clinical diagnosis of community-acquired acute respiratory tract
infection (CA-ARTI):
-- at least two respiratory symptoms: cough, sore throat, runny nose, nasal
congestion, dyspnea AND
-- at least one systemic symptoms: fever, feverish, chills, fatigue, headache,
myalgia, loss of smell, loss of taste AND
-- clinician judges that symptoms are most likely attributable to CA-ARTI.
- Hospitalisation is not considered desirable, but treatment at home is
considered desirable.
- Hypoxemia (SpO2 <94% at rest, and/or increased respiratory effort with
respiratory rate >24/min at rest)
- Partner/caregiver present at the patient's home for providing supportive care
- Capable of using a pulseoximeter (or caregiver can help)
- Age 18 years or older
- Mentally competent
- Sufficient proficiency of the Dutch language to provide informed consent (or
translator available to mitigate the language barrier)
Exclusion criteria
Exclusion criteria for all three patients categories:
- Active smoking (due to associated risks with oxygen therapy)
- Severe dementia or severe psychiatric illness (patient is not able to follow
studyinstructions)
- Inadequate mastery of the Dutch language and absence of care giver who can
translate to mitigate the language barriaer.
Additional exclusion criteria for category 1:
- Severe clinical condition warranting intensive treatment in hospital setting
or ICU admission
- More medical care is necessary than can be organised in the home setting
- Chronic pulmonary disease, heart failure, immunocompromised status, kidney
failure or liver failure of which decompensation risk is deemed too high by
treating physician and necessitates clinical admission
- PE/DVT in past month
Additional exclusion cirteria for category 2:
- severe disease or such critical clinical condition that the physician decides
to abstain all care
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77421.041.21 |
| Other | NTR: NL9459 |
| OMON | NL-OMON22655 |