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

NCT ID: NCT04936360

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2021-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injuries Caregiver Burden

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Caregiver Brain injury Burden Caregiver Strain Index

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

questionnaires for clinical assessments

Intervention Type 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.

questionnaires for clinical assessments

Intervention Type OTHER

questionnaires for clinical assessments

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaires for clinical assessments

questionnaires for clinical assessments

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* under 18 years of age
* inability to read and understand questions.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasin Demir

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fatma Özcan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fatma Özcan

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16

Identifier Type: -

Identifier Source: org_study_id