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

Complex Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04450225
• Other study ID #: RNLI_MFR_2020
• Status: Recruiting
• Start date: July 13, 2020
• Est. completion date: November 2023

Study information

• Verified date: February 2023
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: Martina Pellegrini
• Phone: +39 0522295189
• Email: martina.pellegrini[@]ausl.re.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: November 2023
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

For patient:

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

Related Conditions & MeSH terms

• Complex Patient

Locations

Country	Name	City	State
Italy	Azienda Unità Sanitaria Locale - IRCCS	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Phase_2: to test the Reliability, Construct validity and Responsivness of the Reintegration to Normal Living Index	The Reintegration to Normal Living Index (RNLI) and the Canadian Occupational Performance Measure (COPM) will be administer to the complex patients and their caregiver in different times to test the psychometric properties of the RNLI.	19 months