Complex PatientNCT04450225
The Psychometric Properties of the Italian Version of the Reintegration to Normal Living Index in Complex Patients
An observational study of Complex Patient, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complex Patient
- How many people
- 117 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jul 2020to 16 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- hospitalized in the PMR unit of AUSL-IRCCS of Reggio Emilia
- Rehabilitation Complexity Scale Extended ≥ 9
- Discharge at home
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Unità Sanitaria Locale - IRCCS
Reggio Emilia, Reggio Emilia, 42123
About this study
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
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.
Read the 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
- Complex Patient
- Keywords
- validation study, social participation, rehabilitation, occupational therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start13 Jul 2020
- Primary completion8 Oct 2020
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Martina Pellegrini, Principal investigator, AUSL of Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450225
- Sponsor's protocol ID
- RNLI_MFR_2020
- Status last verified
- Feb 2025
- First submitted
- 23 Jun 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04450225
- Acronym / sponsor ID
- RNLI_MFR_2020
- Conditions
- Complex Patient
- Keywords
- validation study, social participation, rehabilitation, occupational therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- hospitalized in the PMR unit of AUSL-IRCCS of Reggio Emilia
- Rehabilitation Complexity Scale Extended ≥ 9
- Discharge at home
Key exclusion criteria (7 listed)
- 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.
- main caregivers of the patients enrolled
- a rehabilitation healthcare professional with at least 3 years of clinical experience in rehabilitation and reintegration into the living environment of highly complex patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phase_1: to test the Content validity of the Reintegration to Normal Living Index
Time frame: 3 months
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.
1 secondary outcome
Phase_2: to test the Reliability, Construct validity and Responsivness of the Reintegration to Normal Living Index
Time frame: 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Complex Patient
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
Active, not recruiting
Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care
Complex Patient, Multimorbidity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Pellegrini principal investigator
AUSL of Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Patient, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase_1: to test the Content validity of the Reintegration to Normal Living Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.