X-rays; EffectsNCT04005040
Evaluation of Mobile X-ray Within the Triple Aim Method
A study testing Mobile X-ray in people with X-rays; Effects and Health Impairment, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- X-rays; Effects, Health Impairment, Patient Satisfaction
- What is being tested?
- Mobile X-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients referred to a mobile X-ray examination in Aarhus Municipality
Who cannot join
- all other patients referred to an x-ray examination
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- X-rays; Effects, Health Impairment, Patient Satisfaction
- Being tested
- Mobile X-ray
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile X-rayProcedure or surgery
Evaluating the effect of mobile x-ray compared to x-ray at the Hospital
| Study group | Role | What they receive |
|---|---|---|
| Mobile X-ray | Active comparator | Intervention: X-ray examination in the patients own home Receives: Procedure: Mobile X-ray |
| X-ray at the Hospital | Placebo comparator | Control: X-ray at the hospital Receives: Procedure: Mobile X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admissions
How many patients are hospitalized
Measured: one year
Secondary outcomes (1)
patient satisfaction
Measuring satisfaction using questionnaires
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 May 2018
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for X-rays; EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Helene Nørrelund, Decan, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005040
- Sponsor's protocol ID
- Mobile X-ray
- Status last verified
- Jun 2019
- First submitted
- 28 Jun 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is not to share data with other reseachers
Publications
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.
PubMed 28181756
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mobile X-ray Within the Triple Aim Method
- ClinicalTrials.gov ID
- NCT04005040
- Acronym / sponsor ID
- Mobile X-ray
- Conditions
- X-rays; Effects, Health Impairment, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mobile X-ray | Active comparator | Procedure: Mobile X-rayIntervention: X-ray examination in the patients own home |
| X-ray at the Hospital | Placebo comparator | Procedure: Mobile X-rayControl: X-ray at the hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients referred to a mobile X-ray examination in Aarhus Municipality
Key exclusion criteria (1 listed)
- all other patients referred to an x-ray examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile X-rayEvaluating the effect of mobile x-ray compared to x-ray at the Hospital | Procedure or surgery | Mobile X-ray, X-ray at the Hospital |
Primary outcome
Hospital admissions
Time frame: one year
How many patients are hospitalized
1 secondary outcome
patient satisfaction
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Results publication: PubMed 28181756Vigeland 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.
- Individual participant dataSharing planned: No. The plan is not to share data with other reseachers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Nørrelund, Decan principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile X-ray in people with X-rays; Effects and Health Impairment, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admissions (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.