Action research in which the intervention will be developped trough short-cylce evaluation rounds by the research team together with an expert panel. The initital intervention has been designed based on scientific literature review,…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Health condition
COVID-19; SARS-COV-2 infection
Research involving
Sponsors and support
NICUM Huisartsenzorg,
RegiozorgNU,
Huisartsen Utrecht Stad,
Huisartsen Eemland
Intervention
- Other
Outcome measures
Primary outcome
Feasibility defined as reaching a stable, regionally supported intervention to monitor and optimally treat patients with COVID-19 (& other RTI) at home with the use of short-cylce evaluation roundes. We will use data of max. 30 patients.
Secondary outcome
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.
Background summary
Study objective
Study design
Intervention
Josi Boeijen
Universiteitsweg 100
3584 CG
Utrecht
the Netherlands
088 75 681 81
j.a.boeijen@umcutrecht.nl
Josi Boeijen
Universiteitsweg 100
3584 CG
Utrecht
the Netherlands
088 75 681 81
j.a.boeijen@umcutrecht.nl
Age
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.
Inclusion criteria:
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9459 |
| CCMO | NL77421.041.21 |