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RecruitingNCT04450225

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

Testing the Psychometric Properties of the Italian Version of the Reintegration to Normal Living Index in Complex Patients Discharge From Physical Medicine and Rehabilitation Unit: a Validation Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
158 (estimated)
Sponsor
Azienda USL Reggio Emilia - IRCCS · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Since the post-acute phase, patients have occupational needs related to social reintegration, that improve the autonomy, social roles in family, at work and in the community. Unmet needs could lead to a lower level of social reintegration. Healthcare professionals should be able to recognize the level of social reintegration of complex patients discharged from the Physical Medicine Rehabilitation (PRM) unit with the aim to identify those who need intervention aimed at improving social reintegration. The preliminary Italian version of the RNL index (RNLI) will describe the social reintegration level of the target population, once its psychometric properties will be tested.

Detailed description

The investigators will recruit three groups of participants to test the psychometric properties of the Italian version of the RNLI: complex patients, caregivers and stakeholders. Phase\_1: to test the Content validity. The content validity will be tested on 10 complex patients and 10 stakeholders, who will assess the clarity and relevance of the RNLI items, respectively. In this phase, complex patients are hospitalized in the PMR unit. From this first phase, the investigators will obtain the preliminary Italian version of the RNLI to test its psychometric properties. Phase\_2: to test the Reliability, Construct validity and Responsiveness. During the hospitalization in the PMR unit, 138 patients and their caregivers will be recruited. During this phase, the investigators will detect the important occupational activities of complex patients enrolled through a semi-structured interview conducted in person. After discharge, the investigators will contact the patients and their caregivers by telephone at different times (T0, T1 and T2) to test the following psychometric properties through the administration of the Italian version of the RNLI and the Canadian Occupational Performance Measure (COPM). Caregiver will have to answer to the RNLI as a proxy for the patient. The contact times and the psychometric properties that will be tested are: T0\_ 2 weeks after discharge * internal consistency * inter-observer reliability * convergent construct validity T1\_ 10-14 days after T0 \- test-retest reliability T2\_ 6-8 weeks after T0 * discriminant construct validity * responsiveness

Conditions

Timeline

Start date
2020-07-13
Primary completion
2020-10-08
Completion
2025-12-31
First posted
2020-06-29
Last updated
2025-06-25

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04450225. Inclusion in this directory is not an endorsement.