NCT02591602

Brief 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 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:

  1. 1.The first one is to built a network model, with the aim to disseminate clinical use of domiciliary radiology.
  2. 2.The second one is to demonstrate clinical efficiency and cost-effectiveness of domiciliary radiology.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

3.5 years

First QC Date

September 25, 2015

Last Update Submit

October 28, 2015

Conditions

TelemedicineTeleradiologyCost-Benefit AnalysisFrail Elderly

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

    4 years

  • Economic impact of the activation of a teleradiology service for home care teams and nursing homes - cost effectiveness analysis.

    4 years

  • Number of participants with positive impact on life quality as assessed by Nottingham Health Profile (NHP) for quality of life.

    4 years

  • Number of patients and care givers with high degree of satisfaction as assessed by Parasuraman Servqual methods.

    4 years

Study Arms (2)

CASI

EXPERIMENTAL

Teleradiology service for patients residing at home or in nursing homes

Other: Teleradiology Service

CONTROLLI

NO INTERVENTION

X-ray hospital department

Interventions

Teleradiology ServiceOTHER

Teleradiology Service at home or in nursing homes

CASI

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • need of urgent examination (within24 hours)
  • need of X-ray examinations not suitable at home/nursing home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Vittoria Tibaldi, Medicine

    A.O.U. Città della Salute e della Scienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 25, 2015

First Posted

October 29, 2015

Study Start

November 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 29, 2015

Record last verified: 2015-10