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Not yet recruiting NCT06896058

Effect of ınformatıon to caregıvers of Stroke patıents wıth Percutaneous endoscopıc Gastrostomy

No phase Interventional Progressing Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Written and verbal training given to caregivers.
Who it may be relevant to
Registry conditions: Progressing Stroke. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of ınformatıon gıven to caregıvers of Stroke patıents wıth Percutaneous endoscopıc Gastrostomy on Care Burden and Self-care affaırs: a randomızed Controlled trıal

Overview

Stroke is one of the serious neurological disorders that occur due to decreased blood flow to a certain part of the brain due to vascular injuries. Stroke ranks second in Europe among the causes of death in the world, fourth in the USA and second in Turkey. More than half of these patients who continue to live become partially or completely dependent on others for self-care and daily living activities. During this process, self-care is of critical importance in patients performing daily living activities and preventing complications. Self-care and needs of these patients are usually met by family members or relatives. The continuous care and needs of patients who are dependent or semi-dependent in self-care and daily living activities cause caregivers to have difficulty and experience burnout syndrome. This situation negatively affects caregivers physiologically, psychologically, socially and economically. The impact of all these negative situations on the caregiver and the difficulty they experience while providing care are defined as caregiver burden in the literature. If this burden causes the caregiver individual to have difficulty in performing their own daily living activities, it causes the caregiver's self-care ability to decrease or even be unable to perform them. As a result of the literature review, it was noticed that studies evaluating the difficulties experienced by caregivers and their self-care were generally conducted with caregivers who care for individuals with chronic diseases such as oncology and Alzheimer's. For this reason, determining the caregiver burden and providing regular support to caregivers, and providing planned training and counseling can help to suggest solutions to all these problems. Therefore, the aim of the study is to examine the effect of information provided to caregivers of stroke patients on the care burden and self-care ability.çalışmayı kabul etmeyen hastaların yakınları çalışmaya dahil edilmedi.

Detailed description

Stroke is one of the serious neurological disorders that occur due to decreased blood flow to a certain part of the brain due to vascular injuries. Stroke ranks second in Europe among the causes of death in the world, fourth in the USA and second in Turkey. More than half of these patients who continue to live become partially or completely dependent on others for self-care and daily living activities. During this process, self-care is of critical importance in patients performing daily living activities and preventing complications. Self-care and needs of these patients are usually met by family members or relatives. The continuous care and needs of patients who are dependent or semi-dependent in self-care and daily living activities cause caregivers to have difficulty and experience burnout syndrome. This situation negatively affects caregivers physiologically, psychologically, socially and economically. The caregiver's being affected by all these negative situations and having difficulty while providing care is defined as caregiver burden in the literature. If this burden causes the caregiver individual to have difficulty in performing their own daily life activities, it causes the caregiver's self-care ability to decrease or even to be unable to perform them. At the same time, it shows that caregivers experience stress and burnout due to inadequacy in coping with patients' symptoms, unexpected needs arising during the care process, and this process causes changes in the caregivers' lives. Since most individuals have to continue their professional and social roles in addition to being caregivers, their areas of responsibility expand, their quality of life is negatively affected, and they may experience burnout due to changes in their free time and work-related activities. There are a limited number of outdated studies on family caregivers of stroke patients, and these studies reported that the care process has negative effects on the health and well-being of caregivers. Due to the sudden onset of disability and the chronic nature of recovery from stroke, caring for a stroke patient has been found to have a negative impact on the physical, mental, and psychological health of caregivers. As a result of the literature review, it was noticed that studies evaluating the difficulties experienced by caregivers and their self-care were generally conducted with caregivers who care for individuals with chronic diseases such as oncology and Alzheimer's. For this reason, determining the caregiver burden and providing regular support to caregivers, and providing planned training and counseling can help to suggest solutions to all these problems. Therefore, the aim of the study is to examine the effect of information provided to caregivers of stroke patients on the care burden and self-care ability.

Interventions

  • Other Written and verbal training given to caregivers
    Education was provided with a brochure containing information on practices regarding care of stroke patients with PEG, prepared by the researcher in line with literature information.

Primary outcome measures

  • Burden of Care Scale (Burden Interview) [Time frame: 1 year]
  • Determining the caregiver burden and providing regular support to caregivers, planned training and counseling can help find solutions to all these problems. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 18 years of age and older, conscious, person-time and place oriented,
  • No psychiatric problems, no hearing-speech or visual impairments,
  • Can speak Turkish,
  • Patient relatives who accompany the patient in the hospital environment and will continue to provide care at home and who accept the research were included.

Exclusion criteria

  • Relatives of patients who could not be contacted,
  • Resulted in death,
  • Did not accept the study were not included in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06896058 · 26.10.2023-2903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗