NCT04005040

Brief Summary

Background: In foreign countries, mobile x-ray already is being used where transfer to the radiology department at the hospital may be an obstacle. Using mobile x-ray, the x-ray examination is performed in the patients own home with transportable equipment that reminds of the transportable x-ray equipment that is being used in the intensive care units. At The Department of Radiology (DOR), Aarhus University Hospital there is an ongoing project mobile x-ray for patients living in nursing homes in Aarhus. The project will be evaluated inspired by the Triple Aim Approach in three sub studies. Overall aim: The overall aim is to conclude if mobile x-ray improves healthcare for fragile patients. Hypotheses:

  • Patients examined with mobile x-ray have fewer number of hospital admissions compared with patients examined with x-ray at DOR.
  • Patients examined with mobile x-ray are more satisfied with their examination compared with patients examined with x-ray at DOR. Sub study 1 - Population health Aim: The primary aim is to study if mobile x-ray improves the health of the defined population measured in hospital admission. Also to study challenges conducting a RCT. The outcome measures: The primary outcome is hospital admissions. Sub study 2 - Experience of care Aim: The aim is to study the satisfaction with mobile x-ray compared the satisfaction to x-ray at DOR. Methods: Observations, interview and questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

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

Study Start

First participant enrolled

May 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
Last Updated

April 22, 2020

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

June 28, 2019

Last Update Submit

April 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital admissions

    How many patients are hospitalized

    one year

Secondary Outcomes (1)

  • patient satisfaction

    one year

Study Arms (2)

Mobile X-ray

ACTIVE COMPARATOR

Intervention: X-ray examination in the patients own home

Procedure: Mobile X-ray

X-ray at the Hospital

PLACEBO COMPARATOR

Control: X-ray at the hospital

Procedure: Mobile X-ray

Interventions

Mobile X-rayPROCEDURE

Evaluating the effect of mobile x-ray compared to x-ray at the Hospital

Mobile X-rayX-ray at the Hospital

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients referred to a mobile X-ray examination in Aarhus Municipality

You may not qualify if:

  • all other patients referred to an x-ray examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Region Denmark, 8000, Denmark

Location

Related Publications (1)

  • Vigeland E, Bohm RE, Rostad A, Lysdahl KB. Mobile X-ray service for nursing homes. Tidsskr Nor Laegeforen. 2017 Feb 7;137(3):198-202. doi: 10.4045/tidsskr.16.0035. eCollection 2017 Feb. English, Norwegian.

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Portable X-Ray

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Helene Nørrelund, Decan

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is impossible to mask since patients are examined at the hospital or in their own home using mobile X-ray
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 2, 2019

Study Start

May 1, 2018

Primary Completion

April 17, 2019

Study Completion

April 17, 2019

Last Updated

April 22, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

The plan is not to share data with other reseachers

Locations