Palliative CareNCT07078188
The Effect of PEG Use Education on the Care Burden and Quality of Life of Patients' Relatives
A study testing PEG training in people with Palliative Care and Caregiver, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned to evaluate the effects of discharge training on PEG use given to palliative care patients' relatives on the caregiver burden and quality of life of the relatives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Caregiver, Caregiver Burden of Caregivers
- What is being tested?
- PEG training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2023to 30 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The caregiver must be over 18 years old
- The caregiver must be willing and able to participate in the study
- The caregiver must be primarily responsible for the patient's care
- The patient they are caring for must be receiving palliative care
- The patient they are caring for must be receiving PEG feeding
- The patient they are caring for must be over 18 years old
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- The patient they are caring for must have been diagnosed with stroke at least six months ago
- The caregiver must have a mini mental test score of 25 points or more
- The Beck depression scale score must be under 17 points
- The caregiver must have a score of over 16 points on the Readiness to Provide Care Scale
Who cannot join
- The caregiver is under the age of 18
- The caregiver is not willing and able to participate in the research
- The caregiver has a physical disability or serious health problem that makes it difficult to provide care
- The patient they are caring for is under the age of 18
- The patient they are caring for has been diagnosed with cancer, endocrine system or GI disease
- The caregiver has a mini mental test score of less than 25
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- The Beck depression scale score is 17 points or higher
- The caregiver has scored 16 or lower on the Readiness to Provide Care Scale
- The caregiver has communication problems
- The caregiver has been diagnosed with depression or psychiatric disorder
- The caregiver is receiving psychotherapy/psychological support
- The caregiver is taking antidepressants and/or anxiolytics
- The caregiver has sensory loss related to vision and hearing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Üsküdar State Hospital
Istanbul
Cem Yücel, +90216 474 79 00, istanbuldhs21@saglik.gov.tr
Hicran Yıldız, Prof.Dr.
About this study
Official title: The Effect of Discharge Education on PEG Use Given to Palliative Care Patients' Relatives on the Care Burden and Quality of Life of Patients' Relatives
The study was planned to evaluate the effects of discharge training on PEG use given to palliative care patients' relatives on the caregiver burden and quality of life of the relatives.
The main questions that the study aims to answer are as follows:
Read more
- How does PEG training given before discharge affect the knowledge level of caregivers on PEG use?
- How does PEG training given before discharge affect the caregiver burden?
- How does PEG training given before discharge affect the caregiver's caregiver stress?
- How does PEG training given before discharge affect the quality of life of the caregivers?
The researchers will compare the PEG training given before discharge with a control group that did not receive training in this regard in order to evaluate the effects of PEG training given before discharge on the caregiver burden, caregiver stress and quality of life of the caregivers. The study will use a general information form, the Caregiver Burden Scale, the Caregiver Stress Index Form, the SF 36 Quality of Life Scale, and the Percutaneous Endoscopic Gastrostomy Tube Nutrition Information Scale for Caregivers.
Participants:
- Face-to-face interviews will be conducted with caregivers at 0, 1, and 3 months.
- The forms used in the study will be filled out at each interview.
- The intervention group will be trained only at the first interview.
- Conditions
- Palliative Care, Caregiver, Caregiver Burden of Caregivers, Quality of Life of Caregivers, PEG Training
- Being tested
- PEG training, Control
- Keywords
- Palliative care, Nutrition, PEG, Caregiver, caregiver burden, Quality of life, PEG training
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG trainingBehavioural
The caregivers will be given a general information form, the Caregiver Burden Scale, the Caregiver Stress Index Form, the SF 36 Quality of Life Scale, and the Caregiver Knowledge Scale for Nutrition with Percutaneous Endoscopic Gastrostomy Tube at each meeting (0, 1, and 3 months.). The intervention group will be trained on PEG use before discharge at the first interview.
ControlOther
The caregivers will be given a general information form, the Caregiver Burden Scale, the Caregiver Stress Index Form, the SF 36 Quality of Life Scale, and the Caregiver Knowledge Scale for Nutrition with Percutaneous Endoscopic Gastrostomy Tube at each meeting (0.,1. ve 3. monts).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | PEG education Receives: Behavioral: PEG training |
| Control | Other | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver burden level of caregivers
The Caregiver Burden Scale: The scale is scored from 0 to 88. A higher score indicates a higher level of distress.
Measured: 0th month (1st day), 1st month and 3rd month
The quality of life level of the caregivers
Short Form 36- Quality of Life Scale: The scale is scored from 0 to 100. A high score indicates good health.
Measured: 0th month (1st day), 1st month and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start6 Jul 2023
- Primary completion30 Apr 2026
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hicran Yıldız, Uludag University
- Investigators
- Hicran Yıldız, Prof.Dr., Principal investigator, Bursa Uludag Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078188
- Sponsor's protocol ID
- HYildiz
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individuals included in the study were informed that the data obtained would be used and published only within the scope of this study, on condition that their identities remained confidential.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Discharge Education on PEG Use Given to Palliative Care Patients' Relatives on the Care Burden and Quality of Life of Patients' Relatives
- ClinicalTrials.gov ID
- NCT07078188
- Acronym / sponsor ID
- HYildiz
- Conditions
- Palliative Care, Caregiver, Caregiver Burden of Caregivers, Quality of Life of Caregivers, PEG Training
- Keywords
- Palliative care, Nutrition, PEG, Caregiver, caregiver burden, Quality of life, PEG training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 22 Jul 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.
The study was planned to evaluate the effects of discharge training on PEG use given to palliative care patients' relatives on the caregiver burden and quality of life of the relatives.
The main questions that the study aims to answer are as follows:
- How does PEG training given before discharge affect the knowledge level of caregivers on PEG use?
- How does PEG training given before discharge affect the caregiver burden?
- How does PEG training given before discharge affect the caregiver's caregiver stress?
- How does PEG training given before discharge affect the quality of life of the caregivers?
The researchers will compare the PEG training given before discharge with a control group that did not receive training in this regard in order to evaluate the effects of PEG training given before discharge on the caregiver burden, caregiver stress and quality of life of the caregivers. The study will use a general information form, the Caregiver Burden Scale, the Caregiver Stress Index Form, the SF 36 Quality of Life Scale, and the Percutaneous Endoscopic Gastrostomy Tube Nutrition Information Scale for Caregivers.
Participants:
- Face-to-face interviews will be conducted with caregivers at 0, 1, and 3 months.
- The forms used in the study will be filled out at each interview.
- The intervention group will be trained only at the first interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: PEG trainingPEG education |
| Control | Other | Other: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The caregiver must be over 18 years old
- The caregiver must be willing and able to participate in the study
- The caregiver must be primarily responsible for the patient's care
- The patient they are caring for must be receiving palliative care
- The patient they are caring for must be receiving PEG feeding
Key exclusion criteria (13 listed)
- The caregiver is under the age of 18
- The caregiver is not willing and able to participate in the research
- The caregiver has a physical disability or serious health problem that makes it difficult to provide care
- The patient they are caring for is under the age of 18
- The patient they are caring for has been diagnosed with cancer, endocrine system or GI disease
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 |
|---|---|---|
| PEG trainingThe caregivers will be given a general information form, the Caregiver Burden Scale, the Caregiver Stress Index Form, the SF 36 Quality of Life Scale, and the Caregiver Knowledge Scale for Nutrition with Percutaneous Endoscopic Gastrostomy Tube at each meeting (0, 1, and 3 months.). The intervention group will be trained on PEG use before discharge at the first interview. | Behavioural | Intervention |
| ControlThe caregivers will be given a general information form, the Caregiver Burden Scale, the Caregiver Stress Index Form, the SF 36 Quality of Life Scale, and the Caregiver Knowledge Scale for Nutrition with Percutaneous Endoscopic Gastrostomy Tube at each meeting (0.,1. ve 3. monts). | Other | Control |
Primary outcome
Caregiver burden level of caregivers
Time frame: 0th month (1st day), 1st month and 3rd month
The Caregiver Burden Scale: The scale is scored from 0 to 88. A higher score indicates a higher level of distress.
The quality of life level of the caregivers
Time frame: 0th month (1st day), 1st month and 3rd month
Short Form 36- Quality of Life Scale: The scale is scored from 0 to 100. A high score indicates good health.
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 20 Jul 2026.
- Individual participant dataSharing planned: No. Individuals included in the study were informed that the data obtained would be used and published only within the scope of this study, on condition that their identities remained confidential.
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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.
Hicran Yıldız, Prof.Dr. principal investigator
Bursa Uludag Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG training in people with Palliative Care and Caregiver, run by Uludag University 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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?
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?
Contact Hicran Yıldız (+90 2242942450, hicran_yildiz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver burden level of caregivers (time frame: 0th month (1st day), 1st month and 3rd month). 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 20 Jul 2026.