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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2020-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Occupational Therapy in Complex Patients: a Pilot Study

NCT02677766

Complex Patients in Rehabilitation Phase

COMPLETED NA

Early Occupational Therapy Intervention in the Hospital Discharge After Stroke

NCT04835363

Stroke

COMPLETED NA

Studying Rehabilitation Treatments Using Video to Improve Recovery for Adults With Physical Disabilities

NCT07092293

Stroke Spinal Cord Injury Occupational Therapy

RECRUITING

Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke

NCT05855226

Stroke eHealth Occupational Therapy

RECRUITING NA

The Psychometric Properties of the Italian Version of the Reintegration to Normal Living Index in Complex Patients

NCT04450225

Complex Patient

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rehabilitation Occupational Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

masking of outcome assessor to T0

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention

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

Group Type EXPERIMENTAL

Occupational Therapy

Intervention Type 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.

usual care

Intervention Type OTHER

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

usual care

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.