Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness

Disorders of Consciousness Clinical Trial

— SCC_DOC  

Official title:

Validation of a Clinical Complications Scale (CCS) in Patients With Disorders of Consciousness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06167200
• Other study ID #: SCC_DOC
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

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