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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06167200
Other study ID # SCC_DOC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date August 2024

Study information

Verified date December 2023
Source Fondazione Don Carlo Gnocchi Onlus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The clinical condition of severe cognitive-motor impairment of Disorders of Consciousness (DoC; e.g., Vegetative State - VS, and Minimal Consciousness State - MCS), is characterized by a high risk of developing clinical complications. In this study, the investigators propose a new Clinical Complications Scale (CCS) developed to assess the impact of clinical complications on the long-term evolution of a cohort of patients with DoC. This is a multi-site prospective observational study conducted in patients with Severe Acquired Brain Injury and DoC admitted to six centers of Fondazione Don Gnocchi (Italy), with clinical data collection not deviating from routine practice (except for CCS administration). The study is non-commercial and will have a maximum total duration of 24 months. It is planned to assess inter-rater agreement and concurrent validity with a similar instrument (CoCoS scale).


Description:

Validation of a scale for the assessment of clinical complications (Clinical Complications Scale, CCS) on a sample of DoC patients with: - assessment of inter-rater agreement; - assessment of concurrent validity with a similar instrument (CoCoS). This study will be implemented throutgh three phases: (i) Identification of a group of evaluators at participating centers (n=3 per center; total n=18) and training them to administer the CCS and CoCos scales by group videoconference; (ii) Recruitment of a sample of DoC patients (n=7 per center; total n=42) who will each undergo assessment with CCS (administered twice by two independent assessors, A and B) and with CoCoS (administered by a third independent assessor, C); (iii) Evaluation of the degree of agreement between observers in administering the CCS scale (agreement between evaluators A and B) and evaluation of concurrent validity between CCS and CoCoS scale (agreement between evaluators A/B and C). The study involves the collection of the following clinical data for each patient on admission and during the following 15 days: - Demographic data respecting patient anonymity (patient's numeric identification code, age, sex, ethnicity, education); - Anamnestic data (date and etiology of acute event); - Clinical data including blood chemistry tests, clinical complications and related therapies administered as per normal clinical reports in use at enrolling units, and referring to the 15-day period following the date of enrollment. Each patient also will be evaluated with CRS-R scale 3-5 times within one week after enrollment for confirmation of the diagnosis of DoC. Assessments with CCS and CoCoS clinical scales completed on clinical reports referring to medical complications that occurred within 15 days of enrollment. The CCS provides a record of clinical complications in 11 categories corresponding to systems of the body (metabolic abnormalities, disorders-cardiovascular, skin and musculoskeletal problems, gastrointestinal disorders, genito-urinary disorders, respiratory disorders) or categories of clinical problems frequently encountered in the population of patients with DoC (neurosurgical complications, epilepsy and myoclonus, paraosteortropathy, neurovegetative crisis, sepsis; Estraneo et al., 2018). For each category, the severity of complications is graded from 0 (absent complication) to 3 (severe complication) based on the intensity of the therapeutic intervention required, interference with the clinic, and/or frequency and duration of morbid events (an exception is the "sepsis" category for which only presence/absence is recorded). In the case of multiple clinical complications occurring within the same category, the most severe will be considered for the severity score. In this way, a cumulative scale score with range 0-31 can be derived. Descriptive data from the sample at study entry will be expressed in terms of mean and standard deviation for quantitative variables and as frequencies for nominal variables. For the assessment of inter-rater agreement in the administration of the CCS, Fleiss' weighted K-index will be calculated on the individual subscale scores and the total score of the scale administered to each patient by two different operators. For concurrent validity testing between the CCS and CoCoS scales, Fleiss' weighted K-index will be calculated between the scores at the subscales in common between the two instruments, while Spearman's correlation coefficient for ranks will be calculated on the total scores obtained by patients on the two scales.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date August 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of VS or MCS, in accordance with international standard diagnostic criteria (Giacino et al., 2002) and confirmed by Coma Recovery Scale-Revised (CRS-R; Giacino et al., 2004) assessment repeated 3-5 times within a week (Wannez et al., 2017); - Time post-injury =28 days; - age =18 years; - Traumatic, vascular, anoxic, or mixed etiology. Exclusion Criteria: - Absence of the informed consent by the patient's legal representative.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention, study is observational
No intervention, study is observational

Locations

Country Name City State
Italy IRCCS Fondazione Don Carlo Gnocchi Firenze Firenze
Italy Polo Riabilitativo del Levante Ligure Fondazione Don Gnocchi La Spezia
Italy IRCCS S. Maria Nascente Fondazione Don Gnocchi Milano
Italy Istituto Palazzolo Fondazione Don Gnocchi Milano
Italy Centro Spalenza Fondazione Don Gnocchi Rovato
Italy Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS Sant'Angelo Dei Lombardi Avellino

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Estraneo A, Loreto V, Masotta O, Pascarella A, Trojano L. Do Medical Complications Impact Long-Term Outcomes in Prolonged Disorders of Consciousness? Arch Phys Med Rehabil. 2018 Dec;99(12):2523-2531.e3. doi: 10.1016/j.apmr.2018.04.024. Epub 2018 May 26. — View Citation

Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349. — View Citation

Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033. — View Citation

Pistoia F, Carolei A, Bodien YG, Greenfield S, Kaplan S, Sacco S, Pistarini C, Casalena A, De Tanti A, Cazzulani B, Bellaviti G, Sara M, Giacino J. The Comorbidities Coma Scale (CoCoS): Psychometric Properties and Clinical Usefulness in Patients With Disorders of Consciousness. Front Neurol. 2019 Oct 17;10:1042. doi: 10.3389/fneur.2019.01042. eCollection 2019. — View Citation

Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary inter-rater reliability agreement in scores between different examiners 15 days from enrolment
Primary concurrent validity correlation between scores on the CCS and the CoCoS 15 days from enrolment
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