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

NCT04450225 | Completed DMC

• 1 other identifier: RNLI_MFR_2020
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complex Patient

Keywords

validation study; social participation; rehabilitation; occupational therapy

Outcome Measures

Primary Outcomes (1)

• Phase_1: to test the Content validity of the Reintegration to Normal Living Index

  A group of complex patients and stakeholders will report the clarity and the relevance of the items of the Reintegration to Normal Living Index (RNLI), respectively. Thus, the content validity of the RNLI will be tested.

  3 months

Secondary Outcomes (1)

• Phase_2: to test the Reliability, Construct validity and Responsivness of the Reintegration to Normal Living Index

  19 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients admitted to the PMR unit of the AUSL-IRCCS of Reggio Emilia are patients with: disability connected to oncological pathologies, stroke or cerebral hemorrhage outcomes, outcomes of orthopedic interventions for polytrauma or femur fracture, outcomes of brain, spinal or spine neurosurgical operations, limb amputations or acute disabling neurological pathologies (e.g. Guillain-Barrè syndrome, etc.). The length of hospitalization on average is 22.5 days. The percentage of return to home after discharge is 85%, while 9% of patients are discharged to residential structures, retirement homes or long term care. Six percent of patients are transferred back to acute wards for complications.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda Unità Sanitaria Locale - IRCCS

Reggio Emilia, Reggio Emilia, 42123, Italy

Location

Study Officials

• Martina Pellegrini

  AUSL of Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 29, 2020
• Study Start: July 13, 2020
• Primary Completion: October 8, 2020
• Study Completion: October 16, 2025
• Last Updated: April 27, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)