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

NCT04936360 | Completed

• 1 other identifier: 16
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Caregiver Burden

Keywords

Caregiver; Brain injury; Burden; Caregiver Strain Index

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Disability Rating Scale (DRS)

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

• Neurobehavioral Rating Scale-Revised (NBRS-R)

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

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

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

• Functional Ambulation Classification Scale (FACS)

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

• Hospital Anxiety and Depression Scale

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

Study Arms (2)

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

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

Interventions

questionnaires for clinical assessments OTHER

questionnaires for clinical assessments

Caregivers Group; Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acquired brain injury patients and their primer caregivers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Fatma Özcan

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Injuries; Caregiver Burden

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fatma Özcan, MD

  Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 23, 2021
• Study Start: April 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)