NCT07078188

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

June 15, 2025

Last Update Submit

July 12, 2025

Conditions

Keywords

Palliative careNutritionPEGCaregivercaregiver burdenQuality of lifePEG training

Outcome Measures

Primary Outcomes (2)

  • Caregiver burden of caregivers

    The Caregiver Burden Scale

    0th month (1st day), 1st month and 3rd month

  • The quality of life score of the caregivers

    The SF 36 Quality of Life Scale

    0th month (1st day), 1st month and 3rd month

Study Arms (2)

Intervention

EXPERIMENTAL

PEG education

Behavioral: PEG training

Control

OTHER
Other: Control

Interventions

PEG trainingBEHAVIORAL

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.

Intervention
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).

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar State Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Hicran Yıldız, Prof.Dr.

    Bursa Uludag Unversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Quasi-experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 22, 2025

Study Start

July 6, 2023

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Locations