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A randomised controlled pilot trial investigating the feasibility of monitoring patients with or at risk for cardiovascular disease who have symptoms suspected of COVID-19 by pulse oximetry at home

A randomised controlled pilot trial investigating the feasibility of monitoring patients with or at risk for cardiovascular disease who have symptoms suspected of COVID-19 by pulse oximetry at home

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25226
Enrollment
50
Registered
2020-10-06
Start date
2020-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients presenting to primary care with moderate to severe symptoms of COVID-19 (both SARS-CoV-2 positive and untested patients).

Interventions

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.

Sponsors

UMC Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Feasibility defined as successful inclusion of 50 participants within 6 months

Secondary

MeasureTime frame
- 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)

Contacts

Public ContactDorien Zwart

Julius Center for Health Sciences and Primary Care, UMC Utrecht

d.zwart@umcutrecht.nl088 75 681 81

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)