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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05546073
Other study ID # S-20220050
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2022
Est. completion date November 18, 2023

Study information

Verified date November 2023
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Due to ageing-related physiological changes, diagnosing older adults is challenging. Delayed disease recognition lead to adverse health outcomes and increased hospitalisation, which is why there is a need to develop new procedures for timely diagnosis and treatment of older adults. Point-of-care technology, e.g. focused lung ultrasound scan and bedside analysis of blood samples (leucocytes with differential count, electrolytes and creatinine) carried out in the patients' home may support clinical decision-making, and potentially reduce acute hospital admissions. The trial's overall aim is to investigate whether increased point-of-care technology, i.e. focused lung ultrasound scan and bedside blood analysis, used as in-home diagnostics in older adults with acute respiratory symptoms, can qualify the general practitioner's clinical decision-making for early treatment initiation and eventually reduce acute hospital admission.


Description:

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Study Design


Intervention

Other:
Advanced point-of-care technology
The intervention consists of: focused lung ultrasound scan(FLUS) venous blood samples for leucocytes with 5-part differential count, creatinin, sodium, potassium, urea

Locations

Country Name City State
Denmark Siri Smedemark Kolding Region Syddanmark

Sponsors (11)

Lead Sponsor Collaborator
University of Southern Denmark AP Moeller Foundation, Director Emil C Hertz and wife Inger Hertz Foundation, Gangsted Foundation, Hartmann Fonden, Karen Elise Jensen Foundation, Kolding Municipality, Denmark, Merchant L. F. Foghts Foundation, Odense Patient Data Explorative Network, Odense University Hospital, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other The diagnostic accuracy of FLUS conducted by ACNs ACNs conclusions are index test and FLUS-specialist conclusions used as reference test. 7 days
Primary Admission = 30-days Proportion of Admissions during 30 days follow-up 30 days
Secondary Mortality = 30-days Proportion of diseased participants in the intervention group and control group after inclusion during 30 days follow-up 30 days
Secondary Acute admissions at day 0 Proportion of acute admissions on visit day (day 0) Day 0
Secondary Length of hospital admission Number of days admitted to acute-care hospital, long-term acute-care hospital or in an emergency department. 30 days
Secondary Hospital-free days = 30-days Number of days alive that is spend outside of an acute-care hospital, long-term acute-care hospital or in an emergency department, including days spent wholly or in part under "observation" status 30 days
Secondary Complications during hospital admission Number of complications registered in the electronic patient journal during admission including delirium and fall 30 days
Secondary Treatment initiations or changes at day 0 Number of treatment initiation or changed at day 0 including antibiotics, diuretics, inhalation medication, prednisolone, iv fluids, iv antibiotics Day 0
Secondary Treatment initiation or changes = 30-day Number of treatment initiation or changed during 30 days follow-up including antibiotics, diuretics, inhalation medication, prednisolone, iv fluids, iv antibiotics 30 days
Secondary Functional level Measured by proxy assessment of functional level:
Change in amount of home care during 30 days follow-up
number of change of dwelling
30 days
Secondary Re-referrals to the Acute Community Health Care Service Number of re-referrals to the ACHCS 30 days
Secondary Contact to the PCP = 30-days Number of contact to the PCP during 30 days follow-up 30 days
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