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

April 2, 2010 updated by: Azienda Ospedaliera San Giovanni Battista

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy, 10126
        • San Giovanni Battista Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: X-rays at home
Home hospitalized elderly patients undergo X-rays at home
Radiation: Home X-rays
X-rays examinations performed at home
Active Comparator: Hospital X-rays
Home hospitalized elderly patients undergo X-rays examinations in hospital
Radiation: X-rays in hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after the radiological procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital
Time Frame: 1 year
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
Satisfaction of patients and/or families
Time Frame: within 1 month after the procedure
Customer satisfaction is evaluated using an ad hoc questionnaire
within 1 month after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera San Giovanni Battista

Collaborators

FondazioneCRT

Investigators

  • Principal Investigator: Teresa Cammarota, MD, Fifth Radiology Department, San Giovanni Battista Hospital of Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

April 2, 2010

First Posted (Estimate)

April 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 5, 2010

Last Update Submitted That Met QC Criteria

April 2, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0078572

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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