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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936360
• Other study ID #: 16
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: May 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Caregiver Burden
• Wounds and Injuries

Intervention

Other:
• questionnaires for clinical assessments
questionnaires for clinical assessments

Locations

Country	Name	City	State
Turkey	Fatma Özcan	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of one and a half months
Primary	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).	through study completion, an average of one and a half months
Primary	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.	through study completion, an average of one and a half months
Secondary	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.	through study completion, an average of one and a half months
Secondary	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).	through study completion, an average of one and a half months
Secondary	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).	through study completion, an average of one and a half months
Secondary	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)	through study completion, an average of one and a half months
Secondary	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.	through study completion, an average of one and a half months
Secondary	Pittsburgh Sleep Quality Index (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.	through study completion, an average of one and a half months
Secondary	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.	through study completion, an average of one and a half months