CovidTherapy@Home

Not Applicable

Recruiting

• Conditions: <p>COVID-19; SARS-COV-2 infection</p>; 10038716

• Registration Number: NL-OMON22655
• Lead Sponsor: ZilverenKruis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Two types of patients can be included.

Type 1:
Patients with RTI/COVID-19 and hypoxemia and/or respiratory distress without signs of clinical instability who normally would be admitted to a hospital ward for supplemental oxygen treatment.

Type 2:
Patients with RTI/COVID-19 and hypoxemia and/or respiratory distress for whom hospitalisation is not considered desirable.

- Hypoxaemia (SpO2 <94%), and/or respiratory distress (respiratory rate >24/min).
- =18 years of age
- Hemodynamically stable
- Support at home: capable family member, or informal caregiver at home
- Able to operate a pulse-oximeter
- Proficient in Dutch (translator is allowed)

Exclusion Criteria

Type 1 and 2:
-Dementia or severe psychiatric illness which renders the patient unable to follow study instructions
-Known illness that prevents reliable pulse oximetry, e.g. severe anemia, Raynaud’s disease.

Additional exclusion criteria for type 1
- Clinical condition requires more elaborate care than can be organised at home
- Severe comorbidities or risk factors: COPD GOLD class III or IV; Chronic lung condition managed by a pulmonologist; insulin-dependent/poorly controlled diabetes; immunocompromised condition; history of deep vein thrombosis or pulmonary embolism; severe heart failure (NYHA III/IV); renal insufficiency (eGFR <30ml/min/1.73 m2); liver failure (Child-Pugh B or C); severe obesity (BMI>35 kg/m2).

Additional exclusion criteria for type 2
- Patient and physician decide -based on shared decision- to withhold specific treatment altogether when considered being in end-stage.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility defined as reaching a stable, regionally supported intervention to monitor and optimally treat patients with COVID-19 (&amp; other RTI) at home with the use of short-cylce evaluation roundes. We will use data of max. 30 patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will collect data on patient characteristics, disease course (30 day follow-up, days alive out of hospital) and healthcare use through a combination of inclusion forms, GP medical file extractions, patient monitoring diaries, WHODAS 2.0 patient questionnaires. We will conduct and semi-structured interviews with involved healthcare workers and patients.</p><br>