Clinical trial NCT04936360: Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors
Official title: Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Caregiver Burden
Keywords: Caregiver
Brain injury
Burden
Caregiver Strain Index
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acquired brain injury patients and their primer caregivers

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion criteria for the patients:

* have a nonprogressive, non-neurodegenerative acquired brain injury
* able to read or understand the questionnaire
* at least 18 years of age

Inclusion criteria for the caregivers:

* primary caregiver of a patient diagnosed with acquired brain injury
* at least 18 years of age
* had provided care for at least one month
* providing care to the patient for more than 4 h per day
* did not have any major premorbid medical and psychological illnesses
* able to read or understand the questionnaire

Exclusion criteria for patients and caregivers:

* under 18 years of age
* inability to read and understand questions.

Primary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: through study completion, an average of one and a half months
measure: Caregiver Strain Index (CSI)
timeFrame: through study completion, an average of one and a half months
measure: The Satisfaction with Life Scale (SWLS)
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
measure: Disability Rating Scale (DRS)
timeFrame: through study completion, an average of one and a half months
measure: Neurobehavioral Rating Scale-Revised (NBRS-R)
timeFrame: through study completion, an average of one and a half months
measure: Rancho Los Amigos Cognitive Scale-Revised (RLAS-R)
timeFrame: through study completion, an average of one and a half months
measure: Functional Ambulation Classification Scale (FACS)
timeFrame: through study completion, an average of one and a half months
measure: Hospital Anxiety and Depression Scale
timeFrame: through study completion, an average of one and a half months
measure: Pittsburgh Sleep Quality İndex (PSQI)
timeFrame: through study completion, an average of one and a half months
measure: NHP (Nottingham Health Profile)
timeFrame: through study completion, an average of one and a half months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Fatma Özcan
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
name: Fatma Özcan, MD
role: PRINCIPAL_INVESTIGATOR
References: