Training Program for PEG Caregivers: A Structured Intervention Study (PEG-EDU)

Koç University

Status: Not yet enrolling

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

Treatments: Behavioral: Caregiver Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07074301

2024.389.IRB2.171

Details and patient eligibility

About

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.

Full description

This study is designed to improve the caregiving practices of individuals who are responsible for patients receiving long-term enteral nutrition via percutaneous endoscopic gastrostomy (PEG). The study is structured in three phases: (1) identification of caregivers' needs through descriptive and qualitative assessments, (2) development of a theory-based structured education program and a mobile application, and (3) implementation and evaluation of the intervention using a mixed-methods design.

In the first phase, caregivers' knowledge gaps, challenges, and educational needs will be identified through a needs assessment that includes questionnaires and semi-structured interviews. In the second phase, based on the findings of the initial assessment and supported by current clinical guidelines and national health policies, a structured education program and a digital support tool (mobile app) will be developed. The educational content will cover PEG fundamentals, stoma care, tube cleaning, enteral feeding, medication administration via PEG, complication management, and psychosocial support. Educational materials will include videos, animations, texts, and interactive quizzes, and the mobile app will allow asynchronous learning and monitoring.

In the third phase, the education program will be delivered through in-person theoretical and practical sessions, followed by the use of the mobile application. Outcome measures will include caregivers' knowledge level, caregiving burden, self-reported practices, and satisfaction with the intervention. Quantitative data will be collected using validated measurement tools, and qualitative feedback will be gathered to provide a deeper understanding of the intervention's impact. This study is expected to support the standardization of home PEG care and enhance caregiver capacity through sustainable and scalable educational interventions.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Caregiver Training Program

Experimental group

Description:

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

Treatment:

Behavioral: Caregiver Training Program

Routine Care

No Intervention group

Description:

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