NCT05546073

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

October 14, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

September 14, 2022

Last Update Submit

November 28, 2023

Conditions

Acute Respiratory DiseaseAcute Illness

Keywords

acute illnessolder adultsacute home carepre-hospital carepoint-of-care technologygeriatricacute community nursefocused lung ultrasound scanFLUS

Outcome Measures

Primary Outcomes (1)

  • Admission ≤ 30-days

    Proportion of Admissions during 30 days follow-up

    30 days

Secondary Outcomes (10)

  • Mortality ≤ 30-days

    30 days

  • Acute admissions at day 0

    Day 0

  • Length of hospital admission

    30 days

  • Hospital-free days ≤ 30-days

    30 days

  • Complications during hospital admission

    30 days

  • +5 more secondary outcomes

Other Outcomes (1)

  • The diagnostic accuracy of FLUS conducted by ACNs

    7 days

Study Arms (2)

Control - Usual Care

NO INTERVENTION

Participants in the control-arm will undergo usual care. This covers clinical inspection, vital parameters (respiratory rate(breaths/min), saturation (%), blood pressure (mmHg), heart rate (beats/min), body temperature (celsius), and Glasgow Coma Scale) , and point-of-care blood-test for CRP and haemoglobin

Intervention - Advanced point-of-care technology

EXPERIMENTAL

Participants in the intervention-arm will undergo usual care as well as advanced point-of-care technology.

Other: Advanced point-of-care technology

Interventions

Advanced point-of-care technologyOTHER

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

Intervention - Advanced point-of-care technology

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • referred to the ACHCS in Kolding Municipality for in-home assessment
  • dyspnoea
  • cough
  • fever
  • fall
  • functional decline defined as either subjective (not able to perform normal daily activities as usual) or objective functional decline (increased need of home care)

You may not qualify if:

  • moderate to severe cognitive impairment
  • antibiotic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siri Smedemark

Kolding, Region Syddanmark, 6000, Denmark

Location

Related Publications (1)

  • Smedemark SA, Laursen CB, Jarbol DE, Rosenvinge FS, Andersen-Ranberg K. Extended use of point-of-care technology versus usual care for in-home assessment by acute community nurses in older adults with signs of potential acute respiratory disease: an open-label randomised controlled trial protocol. BMC Geriatr. 2024 Feb 16;24(1):161. doi: 10.1186/s12877-024-04774-z.

    PMID: 38365595DERIVED

Study Officials

  • Siri A Smedemark, MD

    Department of Clinical Reasearch, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Karen Andersen-Ranberg, Prof, MD

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 632 participants referred to the acute community health care service for in-home assessment due to acute disease will be enrolled and randomized 1:1 to receive usual care or advanced point-of-care technology
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 19, 2022

Study Start

October 14, 2022

Primary Completion

November 18, 2023

Study Completion

November 18, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)