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

NCT03668938 | Completed

• 1 other identifier: COMPLE-TO_2018
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation; Occupational Therapy

Keywords

Occupational Therapy; Complex Patient; Randomized Control Trial; Social Reintegration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Canadian Occupational Performance Measure

  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

  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

  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

  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

  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

Study Arms (2)

intervention

EXPERIMENTAL

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

Other: Occupational Therapy; Other: usual care

usual care

ACTIVE COMPARATOR

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Other: usual care

Interventions

Occupational Therapy OTHER

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.

intervention

usual care OTHER

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

intervention; usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complex impatient
• Admitted to AUSL-IRCCS/UO MFR

You may not qualify if:

• Language barriers
• Severe cognitive impairment
• Psychiatric disorders
• Domiciled in a protected facility at the time of admission

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Ospedale Santa Maria Nuova

Reggio Emilia, Italy

Location

Related Publications (1)

• Costi S, Pellegrini M, Braglia L, Cavuto S, Fugazzaro S. Occupational therapy improves social participation of complex patients discharged from hospital: results of a powered randomized controlled trial. Disabil Rehabil. 2024 Jun;46(11):2223-2233. doi: 10.1080/09638288.2023.2218653. Epub 2023 Jun 1.

  PMID: 37259592 DERIVED

MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Stefania Fugazzaro

  Local Health Autority of Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: masking of outcome assessor to T0
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: September 13, 2018
• Study Start: October 8, 2018
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: June 24, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)