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临床试验/NCT07074301
NCT07074301尚未招募不适用

Effectiveness of Education and Mobile Application for Percutaneous Endoscopic Gastrostomy Care

Koç University0 个研究点目标入组 80 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
Change in Caregiver Knowledge Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change in Caregiver Knowledge Level

时间窗: Baseline and monthly assessments during 2-month intervention

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.

Change in Caregiver Knowledge Level

时间窗: Baseline and monthly assessments during 2-month intervention

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.

次要结局

  • 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)
  • 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)

研究者

发起方
Koç University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevilay Senol Celik

Professor of Nursing, Koç University School of Nursing

Koç University

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