Occupational Therapy in Complex Patients: a Pilot Study (TO_EFFI15_14)

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.

Study Overview

• Status: Completed
• Conditions: Complex Patients in Rehabilitation Phase
• Intervention / Treatment: Other: occupational therapy; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RE
    • Reggio Emilia, RE, Italy, 42100
      • Arcispedale Santa Maria Nuova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• complex inpatient

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM	Other: 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.
Active Comparator: usual care; Usual care consists in rehabilitation treatment delivered by a multidisciplinary team	Other: Usual care; Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure	The Canadian Occupational Performance Measure is a valid, evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time. The score is between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction	T0 is the baseline at the patient ammission in the rehabilitation Ward; T2 is the follow-up at end of the intervention, 45 days ± 15 days from discharge

Collaborators and Investigators

• Sponsor: Stefania Costi
• Collaborators: Arcispedale Santa Maria Nuova-IRCCS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 20, 2017

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Occupational Therapy; Complex patients; Occupational performance problem; Rehabilitation Complexity Scale
• Other Study ID Numbers: TO_EFFI15_14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Study Data/Documents

1. Clinical Study Report
   Information identifier: TOEFFI15_14
   Information comments:

   Titolo dello studio: Terapia occupazionale nei pazienti complessi : studio pilota.

   Codice protocollo TOEFFI15_14 Data di rilascio: 16/09/15