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| Name | Class |
|---|---|
| Azienda USL Reggio Emilia - IRCCS | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM |
|
| usual care | Active Comparator | Usual care consists in rehabilitation treatment delivered by a multidisciplinary team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| occupational therapy | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcispedale Santa Maria Nuova | Reggio Emilia | RE | 42100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30250407 | Result | Pellegrini M, Formisano D, Bucciarelli V, Schiavi M, Fugazzaro S, Costi S. Occupational Therapy in Complex Patients: A Pilot Randomized Controlled Trial. Occup Ther Int. 2018 Sep 3;2018:3081094. doi: 10.1155/2018/3081094. eCollection 2018. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| TOEFFI15_14 | Clinical Study Report | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Ethnicity not collected
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
to the end of the study, which means 45 days post hosèital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| referred to other wards for clinical reasons | Cardiac disorders | regular investigator | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefania Costi | University of Modena and Reggio Emilia | +390522522441 | stefania.costi@unimore.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2014 | Sep 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| Usual care | Other | Usual care consists in rehabilitation treatment delivered by a multidisciplinary team |
|
Titolo dello studio: Terapia occupazionale nei pazienti complessi : studio pilota. Codice protocollo TOEFFI15_14 Data di rilascio: 16/09/15 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 2 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 2 | 20 | 0 | 20 | 1 | 20 |
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| D013812 |
| Therapeutics |