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Completed

NCT Number: NCT04936360

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fatma Özcan

Ankara, Turkey (Türkiye)

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires for clinical assessments

Other

questionnaires for clinical assessments

Primary outcomes

  1. Functional Independence Measure (FIM)

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

    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.

  2. Caregiver Strain Index (CSI)

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

    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).

  3. The Satisfaction with Life Scale (SWLS)

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

    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.

Secondary outcomes

  1. Disability Rating Scale (DRS)

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

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

  2. Neurobehavioral Rating Scale-Revised (NBRS-R)

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

    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).

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

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

    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).

  4. Functional Ambulation Classification Scale (FACS)

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

    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)

  5. Hospital Anxiety and Depression Scale

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

    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.

  6. Pittsburgh Sleep Quality İndex (PSQI)

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

    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.

  7. NHP (Nottingham Health Profile)

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

    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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2021
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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