Occupational Therapy Intervention in Patients With Complex Needs to Improve Social Reintegration

Study Overview
=================
Brief Summary
-----------------
A previous study that involved the intervention of the occupational therapist (OT) on complex patients both in hospital and at home showed the effectiveness of OT during hospitalization. The effectiveness was not demonstrated in the post-discharge phase. Now, the investigators presented a RCT to compare the levels of social reintegration between the intervention group and control group. The hypothesis is that the intervention group obtains a higher and clinically relevant level of social reintegration compared to the group treated with the usual care.

Detailed Description
-----------------
In the previous study, the intervention group achieved higher gains in the return to normal life than in the control group, but this difference did not reach statistical significance. Because of this, a new study was implemented with the correct sample size, defined through the previous study. In addition, the post-discharge phase the COPM was administered to define new objectives relating mainly to productivity and leisure time areas. Finally, the investigators have indentified some territorial services with the aim to create tailored paths/interventions for patients to promote social reintegration.

Official Title
-----------------
Efficacy of Occupational Therapy in the Rehabilitation of Complex Patients: Randomized Controlled Trial

Conditions
-----------------
Rehabilitation, Occupational Therapy

Intervention / Treatment
-----------------
* Other: Occupational Therapy
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complex impatient Admitted to AUSL-IRCCS/UO MFR Exclusion Criteria: Language barriers Severe cognitive impairment Psychiatric disorders Domiciled in a protected facility at the time of admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>The occupational therapy intervention provides a treatment aimed at improving autonomy in the activities chosen by the patient | Other: Occupational Therapy<br>* The intervention in the hospitalization phase is mainly aimed at achieving the objectives related to the self-care area and, secondly, to the objectives in the areas of productivity and leisure time, identified in T0 and to the environmental assessment of the places of life of the patient; more an intervention in the patient's post-discharge home, mainly aimed at achieving the objectives related to social reintegration, the area of productivity and leisure time and, secondly, to possible objectives in the areas of self-care identified in T1.<br>Other: usual care<br>* Usual care consists in rehabilitation treatment delivered by a multidisciplinary team<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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Reintegration to Normal Living Index | Compare the change in the level of reintegration to normal life between the two arms. The score range is from 1 to 100. Higher values represent a better outcome. | Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure | Compare the results obtained in the two groups in the performance and satisfaction perceived by the patient in carrying out the occupational activities identified as priorities. The score range is from 1 to 10. Higher values represent a better outcome. | Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge | 
| Modified Barthel Index | Compare the results obtained in the two groups in autonomy in the activities of daily life. The score range is from 1 to 100. Higher values represent a better outcome. | Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge | 
| Instrumental Activity of Daily Living | Compare the results obtained in the two groups in autonomy in instrumental activities. The score range is from 1 to 8. Lower values represent a better outcome. | Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge | 
| Hospital Anxiety and Depression Scale | Compare the results obtained in the two groups in anxiety and depression.The scale has 2 subscales that evaluates anxiety and depression, respectively. For both subscales the score range is from 0 to 21. Higher values represent a better outcome. | Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge | 
| Short Form 12 | Compare the results obtained in the two groups in the quality of life. The scale has 2 subscales. The Physical Component Summary has a score range from 11 to 70. The other subscale evaluates the Mental Component Summary with a score range from 7 to 72. Higher values represent a better outcome. | Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Occupational Therapy, Complex Patient, Randomized Control Trial, Social Reintegration