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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregiver Training Program | Experimental | Caregivers receive a structured education program and mobile application support based on Bandura's Social Learning Theory. |
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| Routine Care | No Intervention | Caregivers receive the institution's standard information and support practices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PEG Problems | The impact of the training program and mobile app on the frequency and severity of PEG-related problems (blockage, infection, leakage, etc.) (Data collection form to be used: PEG Problems Monitoring Form). The form includes 12 predefined problem types (e.g., infection, leakage, dislodgement, constipation), and allows for open-ended documentation of additional complications. Each problem is recorded by date, severity (mild/moderate/severe), management approach, and outcome. Problems will be tracked monthly over a 2-month period. Higher number of recorded complications indicates a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sevilay Şenol Çelik, Ph.D. | Contact | +905356666863 | sevilaycelik@ku.edu.tr | |
| Hande Nur ARSLAN | Contact | +905538571396 | harslan20@ku.edu.tr |
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De-identified individual participant data (IPD) that supports the findings of this study will be available upon reasonable request from researchers.
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.
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.
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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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.
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| Baseline and monthly assessments during 2-month intervention |
| Caregiver Burden Perception: | The impact of the training program and mobile app on caregivers' perception of caregiver burden (Scale to be used: Zarit Caregiver Burden Scale). The Caregiver Burden Scale, a 21-item scale measuring the frequency of burden-related experiences. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Almost always). Additionally, general caregiver stress is measured on a visual analogue scale from 0 (no stress) to 10 (extreme stress). Higher scores indicate a greater caregiver burden. | Baseline and monthly assessments during 2-month intervention |
| Training and Mobile Application Satisfaction: | The user-friendliness of the training program and mobile application, and the level of satisfaction (Forms to be used: Training Evaluation Form, Mobile Application Evaluation Form, and Willingness to Use Mobile Application Scale). Caregiver satisfaction was assessed with the Training Evaluation Form (9 Likert-type items, score range: 9-45). Mobile app usability and content were explored via the Mobile Application Evaluation Form, including open-ended qualitative items. Willingness to use the app was measured by the Mobile Application Use Willingness Scale (6 items, 7-point Likert scale, total score: 6-42). Higher scores reflect greater satisfaction or willingness. Data were collected two months post-intervention. | Baseline and monthly assessments during 2-month intervention |
| Effectiveness of the Cleaning Brush | Whether the cleaning brush is effective in maintaining PEG tubes and users' satisfaction with this product (Form to be used: Cleaning Brush Usage Evaluation Form). | Baseline and monthly assessments during 2-month intervention |