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ID
Source
Brief title
Health condition
Patients presenting to primary care with moderate to severe symptoms of COVID-19 (both SARS-CoV-2 positive and untested patients).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility defined as successful inclusion of 50 participants within 6 months
Secondary outcome
- the feeling of safety during the first two weeks of illness as reported by the patient
- disability-free survival at 45 days (% change in WHODAS-2 between baseline and day 45)
- number of days alive at home during 45 days after inclusion
- time to discharge from medical follow-up (defined as last contact with healh care professional according to primary care electronic health record data)
- number of primary care contacts during 45 days after inclusion
- number of emergency care department visits during 45 days after inclusion
- proportion of hospitalised patients within 45 days after inclusion
- characteristics of hospital admissions within 45 days after inclusion
o clinical profile at time of hospitalisation (according to the warning signs of Dutch College of General Practitioners)
o length of stay (total and stratified into ward and ICU)
o proportion of patients admitted to ICU
o type of treatments
- 45 day mortality
o overall mortality
o out-of-hospital mortality
o in-hospital mortality
In a parallel process evaluation, we will examine how:
- the intervention has been used in practice in terms of:
(i) Fidelity - whether the intervention was carried out as planned;
(ii) Dose - whether the intervention has been used as long and frequently as planned;
(iii) Adjustments - whether adjustments have been made to the intervention and why;
(iv) Reach - whether the intended audience has been reached and
- the experiences of patients in the intervention group and their informal caregivers in terms of disease perception, fear and use of the intervention
- GPs' experiences with the intervention (usability of pulseoximetry as diagnostic procedure and impact on healthcare utilization)
Background summary
Patients with moderate to severe symptoms of (presumably) COVID-19 are monitored at home by their GP using teleconsultation. This leaves the GP with a situation in which he/she has to rely on patients' symptom presentation and subjective assessment of shortness of breath by telephone. It is however known that patients' condition can deteriorate considerably after 7-14 days of symptom onset. Such a deterioratation with corresponding low oxygen saturation levels does often not align with patients' symptoms. In particular patients with overweight, hypertension, diabetes and other cardiovascular risk factors and cardiovascular diseases are at increased risk of a more complicated disease course requiring hospitalisation and sometimes even ICU admission.
Several weeks of home monitoring of blood oxygen levels by pulse oximetry might benefit the patient by early detection of hypoxemia, an important indicator for hospitalisation. In the proposed pilot trial, we perform an early phase evaluation of this new intervention in primary care.
Study objective
Several weeks of home monitoring of blood oxygen levels of patients with or at risk of cardiovascular disease with moderate to severe symptoms of (presumably) COVID-19 by pulse oximetry might benefit the patient by early detection of hypoxemia, an important indicator for hospitalisation. In the proposed pilot trial, we perform an early phase evaluation of this new intervention in primary care.
Study design
Patients will be followed for 45 days
Intervention
Three times daily (and if needed any additional) measurement of oxygen saturation and pulse rate with a pulse oximeter as added to usual (primary) care versus usual (primary) care.
Dorien Zwart
088 75 681 81
d.zwart@umcutrecht.nl
Dorien Zwart
088 75 681 81
d.zwart@umcutrecht.nl
Inclusion criteria
1) Age ≥40 years
2) Cardiovasculair risk profile or cardiovascular disease (overweight, hypertension, diabetes, smoking, coronary artery disease, previous myocardial infarction, heart failure)
3) Presumably COVID-19 (both SARS-CoV-2 positive and non-COVID-19 confirmed patients)
4) Moderate-severe symptoms
5) Mentally competent
Exclusion criteria
1) Severe illness requiring hospital admission
2) Patient does not want future hospitalisation
3) Known anemia
4) Inadequate mastery of the Dutch language
5) Not willing to sign informed consent
6) Not willing to adhere to study procedures
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8954 |
| Other | METC Utrecht : METC 20-638/D |