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

NCT ID: NCT04450225

Last Updated: 2025-06-25

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

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Recruitment Status

RECRUITING

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-13

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Complex Patient

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* hospitalized in the PMR unit of AUSL-IRCCS of Reggio Emilia
* Rehabilitation Complexity Scale Extended ≥ 9
* Discharge at home

Exclusion Criteria

* language barrier
* comorbidities that limit communication and/or collaboration (eg aphasia, dementia, cognitive deficits, severe anxious-depressive syndromes pre-existent to hospitalization, etc.)
* discharge in residential structures, retirement homes or long-term care or transferred to acute wards for complications.

For caregiver:

main caregivers of the patients enrolled

For stakeholders:

a rehabilitation healthcare professional with at least 3 years of clinical experience in rehabilitation and reintegration into the living environment of highly complex patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martina Pellegrini

Role: PRINCIPAL_INVESTIGATOR

AUSL of Reggio Emilia

Locations

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Azienda Unità Sanitaria Locale - IRCCS

Reggio Emilia, Reggio Emilia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Martina Pellegrini

Role: CONTACT

00390522295189

Sara Paltrinieri, BSc OT

Role: CONTACT

00390522522416

Facility Contacts

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Martina Pellegrini, Bsc

Role: primary

Sara Paltrinieri, Bsc

Role: backup

00390522522416

Other Identifiers

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RNLI_MFR_2020

Identifier Type: -

Identifier Source: org_study_id

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