Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06167200
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-12-04
Brief Title:
Validation of a Clinical Complications Scale CCS in Patients With Disorders of Consciousness
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Validation of a Clinical Complications Scale CCS in Patients With Disorders of Consciousness
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCC_DOC
Brief Summary:
The clinical condition of severe cognitive-motor impairment of Disorders of Consciousness DoC eg 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
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
Detailed 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 n3 per center total n18 and training them to administer the CCS and CoCos scales by group videoconference ii Recruitment of a sample of DoC patients n7 per center total n42 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 AB 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 patients 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 andor frequency and duration of morbid events an exception is the sepsis category for which only presenceabsence 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 Spearmans correlation coefficient for ranks will be calculated on the total scores obtained by patients on the two scales
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 n3 per center total n18 and training them to administer the CCS and CoCos scales by group videoconference ii Recruitment of a sample of DoC patients n7 per center total n42 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 AB 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 patients 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 andor frequency and duration of morbid events an exception is the sepsis category for which only presenceabsence 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 Spearmans correlation coefficient for ranks will be calculated on the total scores obtained by patients on the two scales
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None