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

Stefania Costi

Status: Completed

Conditions: Complex Patients in Rehabilitation Phase

Treatments: Other: occupational therapy; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02677766

TO_EFFI15_14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• complex inpatient

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: occupational therapy

usual care

Active Comparator group

Description:

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Treatment:

Other: Usual care