Occupational Therapy in Complex Patients: a Pilot Study

NCT02677766 | Completed Results

• 1 other identifier: TO_EFFI15_14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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, the investigators propose one randomized controlled trial that will compare the group receiving the intervention of OT and the control group, to quantify the level of performance and satisfaction in the activities of interest of the patient, identified through the COPM. The hypothesis is that the benefit may be higher, as clinically relevant, in the group of complex patients treated with the proposed intervention of OT compared to those receiving the usual rehabilitation therapy.

Conditions

Complex Patients in Rehabilitation Phase

Keywords

Occupational Therapy; Complex patients; Randomized controlled trial; Occupational performance problem; Rehabilitation Complexity Scale

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure

  The Canadian Occupational Performance Measure is a valid, evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time. The score is between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction

  T0 is the baseline at the patient ammission in the rehabilitation Ward; T2 is the follow-up at end of the intervention, 45 days ± 15 days from discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM

Other: occupational therapy

usual care

ACTIVE COMPARATOR

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Other: Usual care

Interventions

occupational therapy OTHER

an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.

Intervention

Usual care OTHER

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

usual care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• complex inpatient

You may not qualify if:

• primary psychiatric disorders,
• language barriers,
• severe cognitive impairment
• communication disability

Sponsors & Collaborators

• Stefania Costi: lead
• Azienda USL Reggio Emilia - IRCCS: collaborator

Study Sites (1)

Arcispedale Santa Maria Nuova

Reggio Emilia, RE, 42100, Italy

Location

Related Publications (1)

• Pellegrini M, Formisano D, Bucciarelli V, Schiavi M, Fugazzaro S, Costi S. Occupational Therapy in Complex Patients: A Pilot Randomized Controlled Trial. Occup Ther Int. 2018 Sep 3;2018:3081094. doi: 10.1155/2018/3081094. eCollection 2018.

  PMID: 30250407 RESULT

MeSH Terms

Interventions

Occupational Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Results Point of Contact

• Title: Stefania Costi
• Organization: University of Modena and Reggio Emilia

stefania.costi@unimore.it

+390522522441

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc in PT

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 20, 2017
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)