Occupational Therapy in Complex Patients: a Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Occupational Therapy in Complex Patients: a Pilot Study

Conditions
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Complex Patients in Rehabilitation Phase

Intervention / Treatment
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* Other: occupational therapy
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: complex inpatient Exclusion Criteria: primary psychiatric disorders, language barriers, severe cognitive impairment communication disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occupational Therapy, Complex patients, Randomized controlled trial, Occupational performance problem, Rehabilitation Complexity Scale