Brain InjuriesNCT04936360
Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors
An observational study of Brain Injuries and Caregiver Burden, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Caregiver Burden
- What is being tested?
- questionnaires for clinical assessments
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 15 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Acquired brain injury patients and their primer caregivers
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- under 18 years of age
- inability to read and understand questions.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Brain Injuries, Caregiver Burden
- Being tested
- questionnaires for clinical assessments
- Keywords
- Caregiver, Brain injury, Burden, Caregiver Strain Index
- Medical subject headings
- Brain Injuries, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires for clinical assessmentsOther
questionnaires for clinical assessments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: questionnaires for clinical assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: through study completion, an average of one and a half months
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start15 Apr 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Fatma Özcan, MD, Principal investigator, Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936360
- Sponsor's protocol ID
- 16
- Status last verified
- May 2021
- First submitted
- 18 Jun 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors
- ClinicalTrials.gov ID
- NCT04936360
- Acronym / sponsor ID
- 16
- Conditions
- Brain Injuries, Caregiver Burden
- Keywords
- Caregiver, Brain injury, Burden, Caregiver Strain Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Other: questionnaires for clinical assessmentsPatients 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. |
| Caregivers Group | – | Other: questionnaires for clinical assessmentsCaregivers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acquired brain injury patients and their primer caregivers
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- under 18 years of age
- inability to read and understand questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires for clinical assessmentsquestionnaires for clinical assessments | Other | Caregivers Group, Patient Group |
Primary outcome
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.
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).
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.
7 secondary outcomes
Disability Rating Scale (DRS)
Time frame: through study completion, an average of one and a half months
Neurobehavioral Rating Scale-Revised (NBRS-R)
Time frame: through study completion, an average of one and a half months
Rancho Los Amigos Cognitive Scale-Revised (RLAS-R)
Time frame: through study completion, an average of one and a half months
Functional Ambulation Classification Scale (FACS)
Time frame: through study completion, an average of one and a half months
Hospital Anxiety and Depression Scale
Time frame: through study completion, an average of one and a half months
Pittsburgh Sleep Quality İndex (PSQI)
Time frame: through study completion, an average of one and a half months
NHP (Nottingham Health Profile)
Time frame: through study completion, an average of one and a half months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Özcan, MD principal investigator
Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Caregiver Burden, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (FIM) (time frame: through study completion, an average of one and a half months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.