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NCT01098916 Clinical Trial

The RAD-HOME Project: a Pilot Study of Domiciliary Teleradiology

Pneumonia Clinical Trial

— RHP  

Official title:
The RAD-HOME Project: a Randomized Pilot Study of a Domiciliary Teleradiology Program for Frail Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01098916
Other study ID # 0078572
Secondary ID
Status Completed
Phase N/A
First received March 10, 2010
Last updated April 2, 2010
Start date June 2008
Est. completion date June 2009

Study information
Verified date May 2008
Source Azienda Ospedaliera San Giovanni Battista
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- need of urgent examination (within 24 hours),

- need of X-ray examinations not suitable at home.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Radiation:
• Home X-rays
X-rays examinations performed at home
• X-rays in hospital

Locations
Country Name City State
Italy San Giovanni Battista Hospital Torino

Sponsors (2)
Lead Sponsor Collaborator
Azienda Ospedaliera San Giovanni Battista FondazioneCRT

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 24 hours after the radiological procedure No
Secondary 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 1 year No
Secondary Satisfaction of patients and/or families Customer satisfaction is evaluated using an ad hoc questionnaire within 1 month after the procedure No
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