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

Azienda USL Reggio Emilia - IRCCS

Status: Completed

Conditions: Rehabilitation; Occupational Therapy

Treatments: Other: usual care; Other: Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03668938

COMPLE-TO_2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

92 participants in 2 patient groups

intervention

Experimental group

Description:

The occupational therapy intervention provides a treatment aimed at improving autonomy in the activities chosen by the patient

Treatment:

Other: Occupational Therapy

Other: usual care

usual care

Active Comparator group

Description:

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Treatment:

Other: usual care