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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668938
• Other study ID #: COMPLE-TO_2018
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: September 23, 2020

Study information

• Verified date: July 2022
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occupational Therapy
• Rehabilitation

Intervention

Other:
• Occupational Therapy
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.
• usual care
Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria Nuova	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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