Training Program for PEG Caregivers: A Structured Intervention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-05

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Caregiver Training Program

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

Group Type EXPERIMENTAL

Caregiver Training Program

Intervention Type 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.

Routine Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Caregiver Training Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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