Progressing StrokeNCT06896058
Effect of ınformatıon to caregıvers of Stroke patıents wıth Percutaneous endoscopıc Gastrostomy
A study testing Written and verbal training given to caregivers in people with Progressing Stroke, run by Cukurova University.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Progressing Stroke
- What is being tested?
- Written and verbal training given to caregivers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Relatives of patients who could not be contacted,
- Resulted in death,
- Did not accept the study were not included in the study.
About this study
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
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.
Read the 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.
- Conditions
- Progressing Stroke
- Being tested
- Written and verbal training given to caregivers
- Keywords
- stroke patient with peg, care burden, self-care agency, information
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written and verbal training given to caregiversOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | The routine practices of the clinic (nutrition training is shown once by the service nurse) are applied to the relatives of the patients in the control group. No practices will be performed by the researcher. The relatives of the patients in both groups will be called by the researcher on the 15th and 30th days after discharge and the Burden Interview Scale (Appendix-2) and Self-Care Ability Scale (Appendix-3) will be applied. Thus, all relatives of the patients will be evaluated before and after the information. All evaluations and trainings will be performed by the same researcher to ensure standardization of the data. Receives: Other: Written and verbal training given to caregivers |
| Experimental group | Active comparator | On the first day that the patients in the intervention group go to the palliative ward, the researcher will inform the relatives about care with a face-to-face education brochure. This information will take approximately 20 minutes. The researcher will call the relatives of the patients on the 15th and 30th days after discharge. In these calls, the necessary information will be repeated about the issues that the relatives need regarding care. These calls are estimated to take approximately 5 minutes. The researcher will call the relatives of the patients in both groups on the 15th and 30th days after discharge and apply the Burden Interview Scale (Appendix-2) and Self-Care Ability Scale (Appendix-3). In this way, all relatives of the patients will be evaluated before and after the information. All evaluations and trainings will be carried out by the same researcher to ensure standardization of the data. Receives: Other: Written and verbal training given to caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of Care Scale (Burden Interview)
The scale provides a minimum (0) and maximum (88) score. As the score increases, the difficulty experienced by the patient's relative in his/her life increases.
Measured: 1 year
Determining the caregiver burden and providing regular support to caregivers, planned training and counseling can help find solutions to all these problems.
The Caregiver Diagnosis Form, Caregiver Burden Scale and Self-Care Ability Scale, as well as written training materials and brochures, were used.
As the score increases, the difficulty experienced by the patient's relative in his/her life increases.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressing StrokeStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental and control groups will be created
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceylan Kisial, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896058
- Sponsor's protocol ID
- 26.10.2023-2903
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06896058
- Acronym / sponsor ID
- 26.10.2023-2903
- Conditions
- Progressing Stroke
- Keywords
- stroke patient with peg, care burden, self-care agency, information
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental and control groups will be created
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: Written and verbal training given to caregiversThe routine practices of the clinic (nutrition training is shown once by the service nurse) are applied to the relatives of the patients in the control group. No practices will be performed by the researcher. The relatives of the patients in both groups will be called by the researcher on the 15th and 30th days after discharge and the Burden Interview Scale (Appendix-2) and Self-Care Ability Scale (Appendix-3) will be applied. Thus, all relatives of the patients will be evaluated before and after the information. All evaluations and trainings will be performed by the same researcher to ensure standardization of the data. |
| Experimental group | Active comparator | Other: Written and verbal training given to caregiversOn the first day that the patients in the intervention group go to the palliative ward, the researcher will inform the relatives about care with a face-to-face education brochure. This information will take approximately 20 minutes. The researcher will call the relatives of the patients on the 15th and 30th days after discharge. In these calls, the necessary information will be repeated about the issues that the relatives need regarding care. These calls are estimated to take approximately 5 minutes. The researcher will call the relatives of the patients in both groups on the 15th and 30th days after discharge and apply the Burden Interview Scale (Appendix-2) and Self-Care Ability Scale (Appendix-3). In this way, all relatives of the patients will be evaluated before and after the information. All evaluations and trainings will be carried out by the same researcher to ensure standardization of the data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Relatives of patients who could not be contacted,
- Resulted in death,
- Did not accept the study were not included in the study.
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 |
|---|---|---|
| Written and verbal training given to caregiversEducation 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. | Other | Experimental group, control group |
Primary outcome
Burden of Care Scale (Burden Interview)
Time frame: 1 year
The scale provides a minimum (0) and maximum (88) score. As the score increases, the difficulty experienced by the patient's relative in his/her life increases.
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
The Caregiver Diagnosis Form, Caregiver Burden Scale and Self-Care Ability Scale, as well as written training materials and brochures, were used. As the score increases, the difficulty experienced by the patient's relative in his/her life increases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Written and verbal training given to caregivers in people with Progressing Stroke, run by Cukurova University.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Burden of Care Scale (Burden Interview) (time frame: 1 year). The study lists 2 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 26 Mar 2025.