Acute Congestive Heart FailureRHPNCT01098916
The RAD-HOME Project: a Pilot Study of Domiciliary Teleradiology
A study testing Home X-rays and X-rays in hospital in people with Acute Congestive Heart Failure and Exacerbation of COPD, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
Aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Congestive Heart Failure, Exacerbation of COPD, Pneumonia
- What is being tested?
- Home X-rays and X-rays in hospital
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Jun 2009
- 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
- immobilization or chairbound,
- need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet X-rays,
- absence of definite delirium at enrollment according to the Confusion Assessment Method, and
- intermediate or high risk of delirium according to the criteria of Inouye.
Who cannot join
- need of urgent examination (within 24 hours),
- need of X-ray examinations not suitable at home.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The RAD-HOME Project: a Randomized Pilot Study of a Domiciliary Teleradiology Program for Frail Elderly Patients
Aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital.
- Being tested
- Home X-rays, X-rays in hospital
- Keywords
- hospital at home, radiology at home, frail elderly
- Medical subject headings
- Pneumonia, Fractures, Bone, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home X-raysRadiation
X-rays examinations performed at home
X-rays in hospitalRadiation
| Study group | Role | What they receive |
|---|---|---|
| X-rays at home | Experimental | Home hospitalized elderly patients undergo X-rays at home Receives: Radiation: Home X-rays |
| Hospital X-rays | Active comparator | Home hospitalized elderly patients undergo X-rays examinations in hospital Receives: Radiation: X-rays in hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM)
Frail patients, especially old ones,often develop delirium or confusion when moved from their usual environment. In home-hospitalized patients with the same risk of developing delirium, according to the Inouye's criteria, we evaluated the onset of a confusional status after X-rays performed at home or in hospital
Measured: 24 hours after the radiological procedure
Secondary outcomes (2)
Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital
Evaluation of costs includes: costs for transportation, ambulance, equipment (eg, processing costs), materials (eg, CD), technical staff (eg, radiographers, radiologists); for the control group: costs for working time employed by family members and health staff to bring patients to hospital for X.ray examination
Measured: 1 year
Satisfaction of patients and/or families
Customer satisfaction is evaluated using an ad hoc questionnaire
Measured: within 1 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
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 Acute Congestive Heart FailureStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Collaborators
- FondazioneCRT
- Investigators
- Teresa Cammarota, MD, Principal investigator, Fifth Radiology Department, San Giovanni Battista Hospital of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098916
- Sponsor's protocol ID
- 0078572
- Acronym
- RHP
- Status last verified
- May 2008
- First submitted
- 10 Mar 2010
- Last updated
- 5 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ricauda NA, Tibaldi V, Bertone P, Quagliotti E, Tizzani A, Zanocchi M, Isaia GC, Grosso M, Cammarota T, Davini O. The RAD-HOME project: a pilot study of home delivery of radiology services. Arch Intern Med. 2011 Oct 10;171(18):1678-80. doi: 10.1001/archinternmed.2011.336. Epub 2011 Aug 8. No abstract available.
PubMed 21824941
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RAD-HOME Project: a Randomized Pilot Study of a Domiciliary Teleradiology Program for Frail Elderly Patients
- ClinicalTrials.gov ID
- NCT01098916
- Acronym / sponsor ID
- RHP / 0078572
- Keywords
- hospital at home, radiology at home, frail elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Collaborators
- FondazioneCRT
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Apr 2010 (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.
Aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-rays at home | Experimental | Radiation: Home X-raysHome hospitalized elderly patients undergo X-rays at home |
| Hospital X-rays | Active comparator | Radiation: X-rays in hospitalHome hospitalized elderly patients undergo X-rays examinations in hospital |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- immobilization or chairbound,
- need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet X-rays,
- absence of definite delirium at enrollment according to the Confusion Assessment Method, and
- intermediate or high risk of delirium according to the criteria of Inouye.
Key exclusion criteria (2 listed)
- need of urgent examination (within 24 hours),
- need of X-ray examinations not suitable at 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 |
|---|---|---|
| Home X-raysX-rays examinations performed at home | Radiation | X-rays at home |
| X-rays in hospital | Radiation | Hospital X-rays |
Primary outcome
Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM)
Time frame: 24 hours after the radiological procedure
Frail patients, especially old ones,often develop delirium or confusion when moved from their usual environment. In home-hospitalized patients with the same risk of developing delirium, according to the Inouye's criteria, we evaluated the onset of a confusional status after X-rays performed at home or in hospital
2 secondary outcomes
Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital
Time frame: 1 year
Satisfaction of patients and/or families
Time frame: within 1 month after the procedure
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 5 Apr 2010.
- Derived from this study: PubMed 21824941Ricauda NA, Tibaldi V, Bertone P, Quagliotti E, Tizzani A, Zanocchi M, Isaia GC, Grosso M, Cammarota T, Davini O. The RAD-HOME project: a pilot study of home delivery of radiology services. Arch Intern Med. 2011 Oct 10;171(18):1678-80. doi: 10.1001/archinternmed.2011.336. Epub 2011 Aug 8. No abstract available.
Related trials for Acute Congestive Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Teresa Cammarota, MD principal investigator
Fifth Radiology Department, San Giovanni Battista Hospital of Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home X-rays and X-rays in hospital in people with Acute Congestive Heart Failure and Exacerbation of COPD, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
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 5 Apr 2010. 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 Italy. 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. 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?
Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM) (time frame: 24 hours after the radiological procedure). 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 NCT01098916, 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 5 Apr 2010.