TelemedicineRADHOMENCT02591602
Teleradiology Program for Frail Patients Living at Home or in Nursing-homes
A study testing Teleradiology Service in people with Telemedicine and Teleradiology, run by A.O.U. Città della Salute e della Scienza.
Trial summary
Transporting radiology to the patient's home is challenging. Preliminary experiences conducted in Turin (Italy) and Lund (Sweden) indicate that the coupling of simple, light-weight X-ray equipments with a Computed radiography or Digital Radiography systems could be effective for externalization of radiographic… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Telemedicine, Teleradiology, Cost-Benefit Analysis
- What is being tested?
- Teleradiology Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to May 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients residents in nursing homes
- patients cared at home by community care services
- immobilization or chairbound
- need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet X-rays,
Who cannot join
- need of urgent examination (within24 hours)
- need of X-ray examinations not suitable at home/nursing home.
About this study
Transporting radiology to the patient's home is challenging. Preliminary experiences conducted in Turin (Italy) and Lund (Sweden) indicate that the coupling of simple, light-weight X-ray equipments with a Computed radiography or Digital Radiography systems could be effective for externalization of radiographic service.
The image and examination quality has been proved to be the same than those performed with a stationary equipment and analysis on safety of radio-protection systems show a very low risk exposure for health staff as well as for the general population.
Read more
Mobile radiography in nursing homes has shown to be technically feasible and the most beneficial results were that patients avoided unnecessary transport back and forth to the hospital; in both experiences the majority of patients could be treated locally.
The key points of RADHOME project are two:
- The first one is to built a network model, with the aim to disseminate clinical use of domiciliary radiology.
- The second one is to demonstrate clinical efficiency and cost-effectiveness of domiciliary radiology.
Read the detailed description
Europe currently has the highest proportion of older people in the world and is expected to maintain this leading position for the next 50 years.
Population ageing is a great challenge for public health care systems as well as for economic development. As nations age, the prevalence of disability, frailty, and chronic diseases is expected to increase dramatically.
The hospital, which at the moment is the first choice for the delivery of acute medical care, is not an ideal environment for frail, elderly patients. New functional impairment and iatrogenic events such as nosocomial infections, pressure sores, falls and delirium, are common during hospital stay.
With developments in medical and other technologies, people with very complex conditions can increasingly have the possibility to remain at home or in nursing homes rather than in hospital.
Technologies can also improve the quality of life of patients and informal caregivers, allowing people to receive care and remain active at home and in the community, instead of being institutionalized.
These societal changes, such as needs of health care cost reduction and an aging population, are the main driving force for the development of telemedicine, especially for elderly patients.
Residents in nursing homes or patients treated at home by community care services are usually old or very old, multimorbid and often cognitively impaired. For these patients transportation to the hospital for X-ray examinations may be an exhausting and disorienting experience. They are collected by an ambulance or taxi and taken away from their environment and people they know. Patients wait in hospital corridors to have a fairly simple X-ray done and then wait for the pickup.
The first objective of RADHOME is to move equipments instead of patients in order to give a response to the geriatric tsunami and to the demand for more flexible health services, providing a view to advancing the economic efficiency of this service.
Teleradiology has become an essential part of the practice of radiology, with broad implications for care delivery and the organization of work: combining teleradiology and domiciliary X-ray examination has the potential to greatly improve the quality of care for elderly frail patients with acute or chronic conditions.
Until now no wide randomized study on radiology at home has been published. Hence main aim of this project is to carefully analyze feasibility, safety and cost-effectiveness of a public, extra-hospital and domiciliary radiology service for frail elderly or immobile patients, more vulnerable to environmental and social changes than other groups of patients, which health conditions discourage the transportation to hospital.
- Conditions
- Telemedicine, Teleradiology, Cost-Benefit Analysis, Frail Elderly
- Being tested
- Teleradiology Service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleradiology ServiceOther
Teleradiology Service at home or in nursing homes
| Study group | Role | What they receive |
|---|---|---|
| CASI | Experimental | Teleradiology service for patients residing at home or in nursing homes Receives: Other: Teleradiology Service |
| CONTROLLI | No intervention | X-ray hospital department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical impact of the activation of a teleradiology service for home care teams and nursing homes - number of participants with positive clinical impact as assessed by multidimensional assessment.
All patients will be examinated using a standardized protocol which included multidimensional assessment. The multidimensional evaluation will be performed using standardized instruments: Activities of Daily Living (ADL) and Instrumental Activity of Daily Living (IADL) for functional status, Geriatric Depression Scale (GDS) for depression, Mini Mental State Examination (MMSE) for cognitive status, Cumulative Illness Rating Scale (CIRS) for comorbidity, Confusion Assessment Method (CAM) for delirium. A pain evaluation will be performed using the Visual Analogic Scale (VNS).
Measured: 4 years
Secondary outcomes (4)
Organizational impact of the activation of a teleradiology service for home care teams and nursing homes - waiting time and organizational path.
Measured: 4 years
Economic impact of the activation of a teleradiology service for home care teams and nursing homes - cost effectiveness analysis.
Measured: 4 years
Number of participants with positive impact on life quality as assessed by Nottingham Health Profile (NHP) for quality of life.
Technology can also improve the quality of life of patients and informal carers, making it more likely that the people receiving care and their informal carers can continue to stay active at home and in the community instead of being institutionalized.
Measured: 4 years
Number of patients and care givers with high degree of satisfaction as assessed by Parasuraman Servqual methods.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vittoria Tibaldi, A.O.U. Città della Salute e della Scienza
- Investigators
- Vittoria Tibaldi, Medicine, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591602
- Sponsor's protocol ID
- RF-2009 -1550148
- Acronym
- RADHOME
- Status last verified
- Oct 2015
- First submitted
- 25 Sep 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleradiology Program for Frail Patients Living at Home or in Nursing-homes
- ClinicalTrials.gov ID
- NCT02591602
- Acronym / sponsor ID
- RADHOME / RF-2009 -1550148
- Conditions
- Telemedicine, Teleradiology, Cost-Benefit Analysis, Frail Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Oct 2015 (estimated)
- 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.
Transporting radiology to the patient's home is challenging. Preliminary experiences conducted in Turin (Italy) and Lund (Sweden) indicate that the coupling of simple, light-weight X-ray equipments with a Computed radiography or Digital Radiography systems could be effective for externalization of radiographic service.
The image and examination quality has been proved to be the same than those performed with a stationary equipment and analysis on safety of radio-protection systems show a very low risk exposure for health staff as well as for the general population.
Mobile radiography in nursing homes has shown to be technically feasible and the most beneficial results were that patients avoided unnecessary transport back and forth to the hospital; in both experiences the majority of patients could be treated locally.
The key points of RADHOME project are two:
- The first one is to built a network model, with the aim to disseminate clinical use of domiciliary radiology.
- The second one is to demonstrate clinical efficiency and cost-effectiveness of domiciliary radiology.
Detailed description
Europe currently has the highest proportion of older people in the world and is expected to maintain this leading position for the next 50 years.
Population ageing is a great challenge for public health care systems as well as for economic development. As nations age, the prevalence of disability, frailty, and chronic diseases is expected to increase dramatically.
The hospital, which at the moment is the first choice for the delivery of acute medical care, is not an ideal environment for frail, elderly patients. New functional impairment and iatrogenic events such as nosocomial infections, pressure sores, falls and delirium, are common during hospital stay.
With developments in medical and other technologies, people with very complex conditions can increasingly have the possibility to remain at home or in nursing homes rather than in hospital.
Technologies can also improve the quality of life of patients and informal caregivers, allowing people to receive care and remain active at home and in the community, instead of being institutionalized.
These societal changes, such as needs of health care cost reduction and an aging population, are the main driving force for the development of telemedicine, especially for elderly patients.
Residents in nursing homes or patients treated at home by community care services are usually old or very old, multimorbid and often cognitively impaired. For these patients transportation to the hospital for X-ray examinations may be an exhausting and disorienting experience. They are collected by an ambulance or taxi and taken away from their environment and people they know. Patients wait in hospital corridors to have a fairly simple X-ray done and then wait for the pickup.
The first objective of RADHOME is to move equipments instead of patients in order to give a response to the geriatric tsunami and to the demand for more flexible health services, providing a view to advancing the economic efficiency of this service.
Teleradiology has become an essential part of the practice of radiology, with broad implications for care delivery and the organization of work: combining teleradiology and domiciliary X-ray examination has the potential to greatly improve the quality of care for elderly frail patients with acute or chronic conditions.
Until now no wide randomized study on radiology at home has been published. Hence main aim of this project is to carefully analyze feasibility, safety and cost-effectiveness of a public, extra-hospital and domiciliary radiology service for frail elderly or immobile patients, more vulnerable to environmental and social changes than other groups of patients, which health conditions discourage the transportation to hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASI | Experimental | Other: Teleradiology ServiceTeleradiology service for patients residing at home or in nursing homes |
| CONTROLLI | No intervention | –X-ray hospital department |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patients residents in nursing homes
- patients cared at home by community care services
- immobilization or chairbound
- need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet X-rays,
Key exclusion criteria (2 listed)
- need of urgent examination (within24 hours)
- need of X-ray examinations not suitable at home/nursing home.
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 |
|---|---|---|
| Teleradiology ServiceTeleradiology Service at home or in nursing homes | Other | CASI |
Primary outcome
Clinical impact of the activation of a teleradiology service for home care teams and nursing homes - number of participants with positive clinical impact as assessed by multidimensional assessment.
Time frame: 4 years
All patients will be examinated using a standardized protocol which included multidimensional assessment. The multidimensional evaluation will be performed using standardized instruments: Activities of Daily Living (ADL) and Instrumental Activity of Daily Living (IADL) for functional status, Geriatric Depression Scale (GDS) for depression, Mini Mental State Examination (MMSE) for cognitive status, Cumulative Illness Rating Scale (CIRS) for comorbidity, Confusion Assessment Method (CAM) for delirium. A pain evaluation will be performed using the Visual Analogic Scale (VNS).
4 secondary outcomes
Organizational impact of the activation of a teleradiology service for home care teams and nursing homes - waiting time and organizational path.
Time frame: 4 years
Economic impact of the activation of a teleradiology service for home care teams and nursing homes - cost effectiveness analysis.
Time frame: 4 years
Number of participants with positive impact on life quality as assessed by Nottingham Health Profile (NHP) for quality of life.
Time frame: 4 years
Number of patients and care givers with high degree of satisfaction as assessed by Parasuraman Servqual methods.
Time frame: 4 years
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 29 Oct 2015.
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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.
Vittoria Tibaldi, Medicine principal investigator
A.O.U. Città della Salute e della Scienza
Questions about this trial
What is this clinical trial studying?
A study testing Teleradiology Service in people with Telemedicine and Teleradiology, run by A.O.U. Città della Salute e della Scienza.
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 4 inclusion and 2 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Clinical impact of the activation of a teleradiology service for home care teams and nursing homes - number of participants with positive clinical impact as assessed by multidimensional assessment. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.