Complex Patients in Rehabilitation Phase
Conditions
Keywords
Occupational Therapy, Complex patients, Randomized controlled trial, Occupational performance problem, Rehabilitation Complexity Scale
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.
Interventions
OTHERoccupational 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.
OTHERUsual care
Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
Sponsors
Azienda USL Reggio Emilia - IRCCS
Stefania Costi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* complex inpatient
Exclusion criteria
* primary psychiatric disorders, * language barriers, * severe cognitive impairment * communication disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM
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. | 20 |
| Usual Care Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Usual Care | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 20 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 20 Participants | 7 Participants |
| Age, Continuous | 62.75 years STANDARD_DEVIATION 10.99 | 64 years STANDARD_DEVIATION 26.85 | 66.35 years STANDARD_DEVIATION 14.67 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Italy | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 20 | 2 / 20 |
| other Total, other adverse events | 0 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure | 7.28 units on a scale | Standard Deviation 1.67 |
| Usual Care | Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure | 4.77 units on a scale | Standard Deviation 1.89 |