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

• ClinicalTrials.gov Identifier: NCT03668938
• Recruitment Status: Unknown
• First Posted: September 13, 2018
• Last Update Posted: October 16, 2018
• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Information provided by (Responsible Party): Stefania Fugazzaro, Arcispedale Santa Maria Nuova-IRCCS

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rehabilitation; Occupational Therapy	Other: Occupational Therapy; Other: usual care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: masking of outcome assessor to T0
• Primary Purpose: Treatment
• Official Title: Efficacy of Occupational Therapy in the Rehabilitation of Complex Patients: Randomized Controlled Trial
• Actual Study Start Date: October 8, 2018
• Estimated Primary Completion Date: October 2020
• Estimated Study Completion Date: October 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: intervention; The occupational therapy intervention provides a treatment aimed at improving autonomy in the activities chosen by the patient	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.; Other: usual care; Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
Active Comparator: usual care; Usual care consists in rehabilitation treatment delivered by a multidisciplinary team	Other: usual care; Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Outcome Measures

Primary Outcome Measures :

1. Change in Reintegration to Normal Living Index [ Time Frame: 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 :

1. Canadian Occupational Performance Measure [ Time Frame: 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.
2. Modified Barthel Index [ Time Frame: 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.
3. Instrumental Activity of Daily Living [ Time Frame: 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.
4. Hospital Anxiety and Depression Scale [ Time Frame: 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.
5. Short Form 12 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Stefania Fugazzaro; +39 0522 296163; stefania.fugazzaro@ausl.re.it

Contact: Martina Pellegrini, BSc OT; +39 0522 522441; martina.pellegrini@ausl.re.it

Locations

Italy

Ospedale Santa Maria Nuova; Recruiting

Reggio Emilia, Italy

Contact: Stefania Fugazzaro +39 0522 296163 stefania.fugazzaro@ausl.re.it

Sponsors and Collaborators

Arcispedale Santa Maria Nuova-IRCCS

Investigators

• Principal Investigator: Stefania Fugazzaro; Local Health Autority of Reggio Emilia

More Information

• Responsible Party: Stefania Fugazzaro, Principal Investigator, Arcispedale Santa Maria Nuova-IRCCS
• ClinicalTrials.gov Identifier: NCT03668938
• Other Study ID Numbers: COMPLE-TO_2018
• First Posted: September 13, 2018
• Last Update Posted: October 16, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stefania Fugazzaro, Arcispedale Santa Maria Nuova-IRCCS:

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