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

Sponsor
Azienda Ospedaliera San Giovanni Battista (Other)
Overall Status
Completed
CT.gov ID
NCT01098916
Collaborator
FondazioneCRT (Other)
69
Enrollment
1
Location
2
Arms
12
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Home X-rays
  • Radiation: X-rays in hospital
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
The RAD-HOME Project: a Randomized Pilot Study of a Domiciliary Teleradiology Program for Frail Elderly Patients
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Comparison of episodes of delirium related to the radiological procedure at home and in hospital, using the Confusion Assessment Method (CAM) [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

Secondary Outcome Measures

  1. Evaluation of direct and indirect costs of the radiological procedures performed at home or in hospital [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

  2. Satisfaction of patients and/or families [within 1 month after the procedure]

    Customer satisfaction is evaluated using an ad hoc questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Giovanni Battista Hospital Torino Italy 10126

Sponsors and Collaborators

  • Azienda Ospedaliera San Giovanni Battista
  • FondazioneCRT

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01098916
Other Study ID Numbers:
  • 0078572
First Posted:
Apr 5, 2010
Last Update Posted:
Apr 5, 2010
Last Verified:
May 1, 2008
Keywords provided by , ,
hospital at home
radiology at home
frail elderly
Additional relevant MeSH terms:
Osteomyelitis
Heart Failure

Study Results

No Results Posted as of Apr 5, 2010