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

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Caregiver Burden
• Intervention / Treatment: Other: questionnaires for clinical assessments

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).

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Fatma Özcan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acquired brain injury patients and their primer caregivers

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Group; Patients with non-progressive non-neurodegenerative acquired brain damage, who were over 18 years of age, who could establish voluntary social communication will be included in the study.	Other: questionnaires for clinical assessments; questionnaires for clinical assessments
Caregivers Group; Caregivers over the age of 18, who took care of the patient for at least 1 month, and who did not have premorbid medical or psychological problems will be included in the study.	Other: questionnaires for clinical assessments; questionnaires for clinical assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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.	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.	through study completion, an average of one and a half months

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Principal Investigator: Fatma Özcan, MD, Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2021
• Primary Completion (ACTUAL): September 15, 2021
• Study Completion (ACTUAL): September 15, 2021

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (ACTUAL): June 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Caregiver; Burden; Brain injury; Caregiver Strain Index
• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Caregiver Burden
• Other Study ID Numbers: 16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No