NCT04936360 - Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors | Crick | Crick

Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors

N/ACompletedNCT04936360

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital60 enrolled

Overview

Acquired brain injury is a general term including trauma due to head injury or postsurgical damage, vascular accident such as stroke or subarachnoid hemorrhage, toxic or metabolic cause such as hypoglycemia, cerebral anoxia, and infection or inflammation. However acquired brain injury leaves survivors with a considerable burden of physical, cognitive, emotional,behavioural and psychosocial limitations,these individuals often require healthcare, supervision, and support from professional or informal caregivers in some or all of their lives. Therefore, this study have two primary aims: (1) to conclude the level of caregiver's life satisfaction and strain; and (2) to determine the factors predicting strain among the caregivers. İnvestigators believe this study can add to the literature and create awareness on the current state of caregiver's well-being in this part of the world.

Patients will evaluate with respect to their demographic and clinical determinants. In the patient group, ambulation status, disability levels, cognitive status, neurobehavioral results, functional status will evaluate with the Functional Ambulation Classification Scale (FACS), Disability Rating Scale (DRS), Rancho Los Amigos Cognitive Scale-Revised (RLAS-R), Neurobehavioral Rating Scale-Revised (NBRS-R), Functional Independence Measure (FIM) respectively. All assessments will conduct and evaluate by the treating physicians during hospitalization. İnvestigators also will record the type of caregiving (family member or paid professional) and socio-demographic characteristics of the caregivers . Sleep quality will be determined with Pittsburgh Sleep Quality İndex (PSQI), quality of life with NHP (Nottingham Health Profile), level and risk of anxiety and depression with Hospital Anxiety and Depression Scale, satisfaction level with The Satisfaction with Life Scale , care burden with Caregiver Strain Index (CSI).

Study Type

OBSERVATIONAL

Enrollment

60

Conditions

Brain Injuries Caregiver Burden

Outcomes

Primary Outcomes

Functional Independence Measure (FIM)

The FIM measures functional independence with 18 items that assess Self-care (six items), Mobility (seven items), and Cognition (five items). Items are scored 1 through 7 with a score of 1 representing complete dependence and a score of 7 indicating complete independence. The items are summed to obtain a total score ranging from 18 to 126.

Time frame: through study completion, an average of one and a half months

Caregiver Strain Index (CSI)

CSI is a 13-item, self-administered objective questionnaire designed to assess level of stress experienced by the informal caregivers. Participants had to answer all the items as either YES or NO. The scoring was one (1) point for each answer of 'YES' and zero (0) for each answer of 'NO'. The question scores were summed with the maximum score of 13. This score was then divided into 'having strain' (score of ≥7) and 'no strain' (score of \<7).

Time frame: through study completion, an average of one and a half months

The Satisfaction with Life Scale (SWLS)

The SWLS (Satisfaction With Life Scale) provides a global measure of satisfaction with life as an overall summation of a person. It consists of five questions rated on a 7-point Likert scale, from 'strongly agree' (response option 7) to 'strongly disagree' (response option 1). In agreement with previous studies the scores are summed to a total score ranging from 5 to 35. A score of 20 represents the midpoint between satisfied and dissatisfied with life.

Time frame: through study completion, an average of one and a half months

Secondary Outcomes

Disability Rating Scale (DRS)

The Disability Rating Scale consists of eight items, each of which is rated on a scale of 0 to either 3 or 5.

Time frame: through study completion, an average of one and a half months

Neurobehavioral Rating Scale-Revised (NBRS-R)

The Neurobehavioral Rating Scale-revised (NBRS-R) is a widely-used measurement around the world, which focus specifically on brain injury patients. It appears to be a more sensitive tool for monitoring neurobehavioral disturbances. The NBRS-R consists of 29 items with a four-level response (absent, mild, moderate, severe).

Time frame: through study completion, an average of one and a half months

Rancho Los Amigos Cognitive Scale-Revised (RLAS-R)

Rancho Los Amigos Cognitive Scale-Revised (RLAS-R) was used to categorise level of cognitive and behavioral function. RLAS-R levels were dichotomised into 'inferior functioning' (RLAS-R 1-8) and 'superior functioning' (RLAS-R 9-10).

Time frame: through study completion, an average of one and a half months

Functional Ambulation Classification Scale (FACS)

The Functional Ambulation Classification Scale (FACS) classifies patients according to basic motor skills necessary for functional ambulation and ranges from independent walking outside (Category 5) to non-functional walking (Category 0)

Time frame: through study completion, an average of one and a half months

Hospital Anxiety and Depression Scale

Hospital Anxiety and Depression Scale is a scale which is a 14-item questionnaire. Seven items evaluate depression and the other seven items evaluate anxiety. Subscale total scores above 7 indicate an anxiety disorder or depression, respectively.

Time frame: through study completion, an average of one and a half months

Pittsburgh Sleep Quality İndex (PSQI)

The PSQI has 19 items assessing subjectively perceived sleep quality in the previous month. Global scores combine subdomains of sleep duration, sleep disturbance, sleep latency, sleep efficiency, daytime dysfunction, overall sleep quality and medication use. The score range is 0-21, with higher values indicating poorer sleep quality.

Time frame: through study completion, an average of one and a half months

NHP (Nottingham Health Profile)

The NHP is divided into two parts: part 1 comprises 38 statements divided into six domains (energy, pain, emotional reactions, sleep, social isolation, and physical mobility). Part 2 of the NHP, lists six important activities of daily living that are affected negatively if the patient has a poor state of health.

Time frame: through study completion, an average of one and a half months