Occupational Therapy in Complex Patients: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Complex Patients in Rehabilitation Phase
- Sponsor
- Stefania Costi
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Stefania Costi
MSc in PT
University of Modena and Reggio Emilia
Eligibility Criteria
Inclusion Criteria
- •complex inpatient
Exclusion Criteria
- •primary psychiatric disorders,
- •language barriers,
- •severe cognitive impairment
- •communication disability
Outcomes
Primary Outcomes
Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure
Time Frame: 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