Effectiveness of Occupational Therapy Intervention in Complex Patients

NCT ID: NCT02173197

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-03-31

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.

Detailed Description

We will therefore first af all to implement an observational pilot study, aimed at defining the characteristics and needs of the population in question, and the OT intervention "protocol". This information will then be used to implement a subsequent randomized controlled trial designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.

Conditions

Complex Patients: Patients With High Level of Complexity Regardless of the Pathology of Origin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

Stefania Costi

OTHER

Sponsor Role: lead

Responsible Party

Stefania Costi

Physical Therapist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stefania Fugazzaro, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda USL Reggio Emilia - IRCCS

Claudio Tedeschi, MD

Role: STUDY_CHAIR

Arcospedale Santa Maria Nuova - IRCCS

References

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.

Reference Type: RESULT

PMID: 28264614 (View on PubMed)

Other Identifiers

TO_Pilota

Identifier Type: -

Identifier Source: org_study_id