Occupational Therapy in Complex Patients: a Pilot Study

NCT ID: NCT02677766

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-10-20

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, the investigators propose one randomized controlled trial that will compare the group receiving the intervention of OT and the control group, to quantify the level of performance and satisfaction in the activities of interest of the patient, identified through the COPM. The hypothesis is that the benefit may be higher, as clinically relevant, in the group of complex patients treated with the proposed intervention of OT compared to those receiving the usual rehabilitation therapy.

Detailed Description

The investigators already implemented an observational pilot study, aimed at defining the characteristics and needs of the population in question and the OT intervention characteristics. These information will now be used to implement this randomized controlled trial, designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.

This study will be set with exploratory purposes, with appropriate high number, which will allow the investigators to quantify the difference between the two groups in terms of performance scores derived from the COPM (COPM_p). From the results of this part it will then depend on the planning for the subsequent study with the correct sample size.

Conditions

Complex Patients in Rehabilitation Phase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM

Group Type: EXPERIMENTAL

occupational therapy

Intervention Type: OTHER

an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.

usual care

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Interventions

occupational therapy

an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.

Intervention Type: OTHER

Usual care

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• complex inpatient

Exclusion Criteria

• primary psychiatric disorders,
• language barriers,
• severe cognitive impairment
• communication disability

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 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

MSc in PT

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Arcispedale Santa Maria Nuova

Reggio Emilia, RE, Italy

Countries

Italy

References

Pellegrini M, Formisano D, Bucciarelli V, Schiavi M, Fugazzaro S, Costi S. Occupational Therapy in Complex Patients: A Pilot Randomized Controlled Trial. Occup Ther Int. 2018 Sep 3;2018:3081094. doi: 10.1155/2018/3081094. eCollection 2018.

Reference Type: RESULT

PMID: 30250407 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

Document Type: Clinical Study Report

Titolo dello studio: Terapia occupazionale nei pazienti complessi : studio pilota. Codice protocollo TOEFFI15\_14 Data di rilascio: 16/09/15

View Document

Other Identifiers

TO_EFFI15_14

Identifier Type: -

Identifier Source: org_study_id