Occupational Therapy in Complex Patients: a Pilot Study

Not Applicable

Completed

• Conditions: Complex Patients in Rehabilitation Phase
• Interventions: Other: occupational therapy; Other: Usual care

• Registration Number: NCT02677766
• Lead Sponsor: Stefania Costi

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.

Study Timeline

• Study First Submitted: 2016-01-29
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Primary Completion: 2017-10
• Study Completion: 2017-10-20
• Results First Submitted: 2019-05-09
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Results First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• complex inpatient

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	occupational therapy	Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM
usual care	Usual care	Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure	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	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

Trial Locations

Locations (1)

Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, RE, Italy