Training Program for PEG Caregivers: A Structured Intervention Study

NCT07074301 | Not Yet Recruiting

• 1 other identifier: 2024.389.IRB2.171
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to develop and evaluate a structured education program and a mobile application to support caregivers of patients receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG). The intervention focuses on improving caregivers' knowledge, care practices, and perceived burden. The study will be conducted in three phases: a needs assessment, development of the education and digital support modules, and implementation of the intervention. Quantitative and qualitative data will be collected to evaluate the impact of the intervention. The results are expected to contribute to the improvement of home PEG care quality and the empowerment of caregivers.

Conditions

Percutaneous Endoscopic Gastrostomy (PEG); Training; Caregiver Burden; Nutritional Support; Training Effectiveness

Keywords

Percutaneous endoscopic gastrostomy; Caregiver Burden; Structured Training; Home Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Knowledge Level

  The effect of the training program and mobile application on the change in the knowledge level of caregivers (Data collection form to be used: Percutaneous Endoscopic Gastrostomy Care Knowledge Level Assessment Form). The form includes 28 items addressing PEG care (e.g., stoma care, tube maintenance, feeding, medication). Each correct answer scores 1 point. The total score ranges from 0 (lowest) to 28 (highest). Higher scores indicate greater knowledge.

  Baseline and monthly assessments during 2-month intervention

Secondary Outcomes (4)

• PEG Problems

  Baseline and monthly assessments during 2-month intervention

• Caregiver Burden Perception:

  Baseline and monthly assessments during 2-month intervention

• Training and Mobile Application Satisfaction:

  Baseline and monthly assessments during 2-month intervention

• Effectiveness of the Cleaning Brush

  Baseline and monthly assessments during 2-month intervention

Study Arms (2)

Caregiver Training Program

EXPERIMENTAL

Caregivers receive a structured education program and mobile application support based on Bandura's Social Learning Theory.

Behavioral: Caregiver Training Program

Routine Care

NO INTERVENTION

Caregivers receive the institution's standard information and support practices.

Interventions

Caregiver Training Program BEHAVIORAL

The intervention consists of a two-month structured education program including two face-to-face sessions and a mobile application. The training content covers PEG care, stoma and tube management, enteral nutrition, drug administration via tube, and troubleshooting complications.

Caregiver Training Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Willingness to participate voluntarily in the study
• No communication barriers
• Ability to use a smartphone
• No diagnosed psychiatric disorder
• Providing care to a patient aged 18 or older who is scheduled to undergo PEG placement

You may not qualify if:

• Discharge from hospital or death of the patient during the study period
• Being under 18 years old
• Illiteracy of the caregiver

Sponsors & Collaborators

• Koç University: lead

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Sevilay Şenol Çelik, Ph.D.

CONTACT

+905356666863; sevilaycelik@ku.edu.tr

Hande Nur ARSLAN

CONTACT

+905538571396; harslan20@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcomes assessor will be blinded to group assignments. Participants, care providers, and investigators will be aware of the intervention allocation due to the nature of the education and mobile application. Data analysis will be performed by an independent statistician to minimize bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing, Koç University School of Nursing

Model Details: This is a two-arm, parallel, randomized controlled trial involving caregivers of patients with PEG in Koç University Hospital. Participants will be randomly assigned to intervention (structured education and mobile application based on Bandura's Social Learning Theory) or control (routine care). Block randomization will be used, considering caregiver age and education level. Allocation concealment will be ensured via computer software. Data will be collected using standardized tools and analyzed independently to reduce bias.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: September 5, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data (IPD) and supporting documents (Study Protocol, SAP) will be available beginning 6 months after publication of the final results and will remain accessible for 3 years. Access will be granted upon reasonable request to the principal investigator.
• Access Criteria: Researchers who provide a methodologically sound proposal will be able to access de-identified individual participant data (IPD), the study protocol, and the statistical analysis plan. Requests should be submitted to the principal investigator via institutional email and will be evaluated on a case-by-case basis. Data access will be granted through a secure institutional repository.