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

Not Applicable

Completed

• Conditions: Rehabilitation; Occupational Therapy
• Interventions: Other: Occupational Therapy; Other: usual care

• Registration Number: NCT03668938
• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS

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.

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2018-10-08
• Primary Completion: 2020-09-23
• Study Completion: 2020-09-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Occupational Therapy	The occupational therapy intervention provides a treatment aimed at improving autonomy in the activities chosen by the patient
intervention	usual care	The occupational therapy intervention provides a treatment aimed at improving autonomy in the activities chosen by the patient
usual care	usual care	Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Primary Outcome Measures

Name	Time	Method
Change in Reintegration to Normal Living Index	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	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.
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	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.
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	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.

Trial Locations

Locations (1)

Ospedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy