Clinical trial NCT03668938: Occupational Therapy Intervention in Patients With Complex Needs to Improve Social Reintegration
Official title: Efficacy of Occupational Therapy in the Rehabilitation of Complex Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Occupational Therapy
Keywords: Occupational Therapy
Complex Patient
Randomized Control Trial
Social Reintegration
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2018-09-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Reintegration to Normal Living Index
timeFrame: 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 outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: 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
measure: Modified Barthel Index
timeFrame: 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
measure: Instrumental Activity of Daily Living
timeFrame: 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
measure: Hospital Anxiety and Depression Scale
timeFrame: 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
measure: Short Form 12
timeFrame: 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
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Ospedale Santa Maria Nuova
Study officials:
affiliation: Local Health Autority of Reggio Emilia
name: Stefania Fugazzaro
role: PRINCIPAL_INVESTIGATOR
References: