Training Program for PEG Caregivers: A Structured Intervention Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caregiver Training Program.
- Who it may be relevant to
- Registry conditions: Percutaneous Endoscopic Gastrostomy (PEG), Training, Caregiver Burden, Nutritional Support. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Education and Mobile Application for Percutaneous Endoscopic Gastrostomy Care
Overview
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.
Detailed 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.
Interventions
- Behavioral 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.
Primary outcome measures
- Change in Caregiver Knowledge Level [Time frame: Baseline and monthly assessments during 2-month intervention]
Secondary outcome measures (4)
- PEG Problems [Time frame: Baseline and monthly assessments during 2-month intervention]
- Caregiver Burden Perception: [Time frame: Baseline and monthly assessments during 2-month intervention]
- Training and Mobile Application Satisfaction: [Time frame: Baseline and monthly assessments during 2-month intervention]
- Effectiveness of the Cleaning Brush [Time frame: Baseline and monthly assessments during 2-month intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07074301 · 2024.389.IRB2.171