NCT02173197

Brief Summary

To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient. For this reason, we intend to undertake a study that will allow us to deepen the knowledge about the impact of the OT on in-hospital patients considered "complex" according to the assessment by the Rehabilitation Complexity Scale (RCS ). Our hypothesis is that the intervention of OT can improve their care by qualified and focused on the needs of the person interventions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

June 23, 2014

Last Update Submit

December 28, 2017

Conditions

Keywords

Occupational TherapyComplex patientsOccupational performance problemRehabilitation Complexity Scale

Outcome Measures

Primary Outcomes (1)

  • Canadian Occupational Performance Measure (COPM)

    Canadian occupational performance measure

    enrollment

Study Arms (1)

OT arm

Through the initial evaluation of the complex patients' needs, the OT will propose a targeted intervention to the needs emerged and decide which approach will use to achieve the goal (i.e. compensatory or restorative). We will describe the characteristics of the population included and identify common needs and problems of the complex patients through the COPM. The needs and problems identified will be grouped into macro-areas, and the OT will propose the appropriate treatment on the basis of the area identified, the patient's needs and the available resources regardless of the origin of the disease.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-hospital complexes patients as defined by way of the Rehabilitation Complexity Scale, regardless of the diagnosis and in charge of the rehabilitation ward

You may qualify if:

  • years old
  • in charge of the rehabilitation ward of the hospital
  • defined complexes as assessed by RCS
  • consent to the processing of sensitive data for research purposes.

You may not qualify if:

  • primary psychiatric conditions
  • language barrier;
  • cognitive impairment
  • communicative disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schiavi M, Costi S, Pellegrini M, Formisano D, Borghi S, Fugazzaro S. Occupational therapy for complex inpatients with stroke: identification of occupational needs in post-acute rehabilitation setting. Disabil Rehabil. 2018 May;40(9):1026-1032. doi: 10.1080/09638288.2017.1283449. Epub 2017 Feb 7.

Study Officials

  • Stefania Fugazzaro, MD

    Azienda USL Reggio Emilia - IRCCS

    PRINCIPAL INVESTIGATOR
  • Claudio Tedeschi, MD

    Arcospedale Santa Maria Nuova - IRCCS

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 24, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

January 2, 2018

Record last verified: 2017-12