Effectiveness of Occupational Therapy Intervention in Complex Patients (OT)

December 28, 2017 updated by: Stefania Costi

Study on the Effectiveness of Occupational Therapy Intervention in Complex Patients.

To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient.

For this reason, we intend to undertake a study that will allow us to deepen the knowledge about the impact of the OT on in-hospital patients considered "complex" according to the assessment by the Rehabilitation Complexity Scale (RCS ).

Our hypothesis is that the intervention of OT can improve their care by qualified and focused on the needs of the person interventions.

Study Overview

Status

Completed

Conditions

Detailed Description

We will therefore first af all to implement an observational pilot study, aimed at defining the characteristics and needs of the population in question, and the OT intervention "protocol". This information will then be used to implement a subsequent randomized controlled trial designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In-hospital complexes patients as defined by way of the Rehabilitation Complexity Scale, regardless of the diagnosis and in charge of the rehabilitation ward

Description

Inclusion Criteria:

  • 18 years old
  • in charge of the rehabilitation ward of the hospital
  • defined complexes as assessed by RCS
  • consent to the processing of sensitive data for research purposes.

Exclusion Criteria:

  • primary psychiatric conditions
  • language barrier;
  • cognitive impairment
  • communicative disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OT arm

Through the initial evaluation of the complex patients' needs, the OT will propose a targeted intervention to the needs emerged and decide which approach will use to achieve the goal (i.e. compensatory or restorative).

We will describe the characteristics of the population included and identify common needs and problems of the complex patients through the COPM.

The needs and problems identified will be grouped into macro-areas, and the OT will propose the appropriate treatment on the basis of the area identified, the patient's needs and the available resources regardless of the origin of the disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure (COPM)
Time Frame: enrollment
Canadian occupational performance measure
enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefania Costi

Collaborators

Arcispedale Santa Maria Nuova-IRCCS

Investigators

  • Principal Investigator: Stefania Fugazzaro, MD, Arcispedale Santa Maria Nuova-IRCCS
  • Study Chair: Claudio Tedeschi, MD, Arcospedale Santa Maria Nuova - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TO_Pilota

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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