<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04450225</url>
  </required_header>
  <id_info>
    <org_study_id>RNLI_MFR_2020</org_study_id>
    <nct_id>NCT04450225</nct_id>
  </id_info>
  <brief_title>The Psychometric Properties of the Italian Version of the Reintegration to Normal Living Index in Complex Patients</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Unità Sanitaria Locale Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Unità Sanitaria Locale Reggio Emilia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since the post-acute phase, patients have occupational needs related to social reintegration,&#xD;
      that improve the autonomy, social roles in family, at work and in the community.&#xD;
&#xD;
      Unmet needs could lead to a lower level of social reintegration. Healthcare professionals&#xD;
      should be able to recognize the level of social reintegration of complex patients discharged&#xD;
      from the Physical Medicine Rehabilitation (PRM) unit with the aim to identify those who need&#xD;
      intervention aimed at improving social reintegration.&#xD;
&#xD;
      The preliminary Italian version of the RNL index (RNLI) will describe the social&#xD;
      reintegration level of the target population, once its psychometric properties will be&#xD;
      tested.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will recruit three groups of participants to test the psychometric&#xD;
      properties of the Italian version of the RNLI: complex patients, caregivers and stakeholders.&#xD;
&#xD;
      Phase_1: to test the Content validity. The content validity will be tested on 10 complex&#xD;
      patients and 10 stakeholders, who will assess the clarity and relevance of the RNLI items,&#xD;
      respectively. In this phase, complex patients are hospitalized in the PMR unit.&#xD;
&#xD;
      From this first phase, the investigators will obtain the preliminary Italian version of the&#xD;
      RNLI to test its psychometric properties.&#xD;
&#xD;
      Phase_2: to test the Reliability, Construct validity and Responsiveness. During the&#xD;
      hospitalization in the PMR unit, 138 patients and their caregivers will be recruited. During&#xD;
      this phase, the investigators will detect the important occupational activities of complex&#xD;
      patients enrolled through a semi-structured interview conducted in person.&#xD;
&#xD;
      After discharge, the investigators will contact the patients and their caregivers by&#xD;
      telephone at different times (T0, T1 and T2) to test the following psychometric properties&#xD;
      through the administration of the Italian version of the RNLI and the Canadian Occupational&#xD;
      Performance Measure (COPM). Caregiver will have to answer to the RNLI as a proxy for the&#xD;
      patient.&#xD;
&#xD;
      The contact times and the psychometric properties that will be tested are:&#xD;
&#xD;
      T0_ 2 weeks after discharge&#xD;
&#xD;
        -  internal consistency&#xD;
&#xD;
        -  inter-observer reliability&#xD;
&#xD;
        -  convergent construct validity&#xD;
&#xD;
      T1_ 10-14 days after T0&#xD;
&#xD;
      - test-retest reliability&#xD;
&#xD;
      T2_ 6-8 weeks after T0&#xD;
&#xD;
        -  discriminant construct validity&#xD;
&#xD;
        -  responsiveness&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Actual">October 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Phase_1: to test the Content validity of the Reintegration to Normal Living Index</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase_2: to test the Reliability, Construct validity and Responsivness of the Reintegration to Normal Living Index</measure>
    <time_frame>19 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">296</enrollment>
  <condition>Complex Patient</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients admitted to the PMR unit of the AUSL-IRCCS of Reggio Emilia are patients with:&#xD;
        disability connected to oncological pathologies, stroke or cerebral hemorrhage outcomes,&#xD;
        outcomes of orthopedic interventions for polytrauma or femur fracture, outcomes of brain,&#xD;
        spinal or spine neurosurgical operations, limb amputations or acute disabling neurological&#xD;
        pathologies (e.g. Guillain-Barrè syndrome, etc.). The length of hospitalization on average&#xD;
        is 22.5 days. The percentage of return to home after discharge is 85%, while 9% of patients&#xD;
        are discharged to residential structures, retirement homes or long term care. Six percent&#xD;
        of patients are transferred back to acute wards for complications.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For patient:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalized in the PMR unit of AUSL-IRCCS of Reggio Emilia&#xD;
&#xD;
          -  Rehabilitation Complexity Scale Extended ≥ 9&#xD;
&#xD;
          -  Discharge at home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  language barrier&#xD;
&#xD;
          -  comorbidities that limit communication and/or collaboration (eg aphasia, dementia,&#xD;
             cognitive deficits, severe anxious-depressive syndromes pre-existent to&#xD;
             hospitalization, etc.)&#xD;
&#xD;
          -  discharge in residential structures, retirement homes or long-term care or transferred&#xD;
             to acute wards for complications.&#xD;
&#xD;
        For caregiver:&#xD;
&#xD;
        main caregivers of the patients enrolled&#xD;
&#xD;
        For stakeholders:&#xD;
&#xD;
        a rehabilitation healthcare professional with at least 3 years of clinical experience in&#xD;
        rehabilitation and reintegration into the living environment of highly complex patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martina Pellegrini</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUSL of Reggio Emilia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martina Pellegrini</last_name>
    <phone>+39 0522295189</phone>
    <email>martina.pellegrini@ausl.re.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sara Paltrinieri, BSc OT</last_name>
    <phone>00390522522416</phone>
    <email>sara.paltrinieri@ausl.re.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Azienda Unità Sanitaria Locale - IRCCS</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martina Pellegrini, Bsc</last_name>
      <email>martina.pellegrini@ausl.re.it</email>
    </contact>
    <contact_backup>
      <last_name>Sara Paltrinieri, Bsc</last_name>
      <phone>00390522522416</phone>
      <email>sara.paltrinieri@ausl.re.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Unità Sanitaria Locale Reggio Emilia</investigator_affiliation>
    <investigator_full_name>Martina Pellegrini</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>validation study</keyword>
  <keyword>social participation</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>occupational therapy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04450225
org study id: RNLI_MFR_2020
nct id: NCT04450225
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Other
time perspective: Prospective
measure: Phase_1: to test the Content validity of the Reintegration to Normal Living Index
time frame: 3 months
description: 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.
measure: Phase_2: to test the Reliability, Construct validity and Responsivness of the Reintegration to Normal Living Index
time frame: 19 months
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Martina Pellegrini
role: Principal Investigator
affiliation: AUSL of Reggio Emilia
last name: Martina Pellegrini
phone: +39 0522295189
email: martina.pellegrini@ausl.re.it
last name: Sara Paltrinieri, BSc OT
phone: 00390522522416
email: sara.paltrinieri@ausl.re.it
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Unità Sanitaria Locale Reggio Emilia
investigator full name: Martina Pellegrini
investigator title: Principal Investigator
sharing ipd: No