Training Program for PEG Caregivers: A Structured Intervention Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKoç University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 or older

Willingness to participate voluntarily in the study

No communication barriers

Ability to use a smartphone

Disqualifiers

Discharge from hospital or death of the patient during the study period

Being under 18 years old

Illiteracy of the caregiver

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Caregiver Training ProgramExperimental treatment 1 intervention
Group B: Routine CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and monthly assessments during 2-month intervention

Secondary outcomes

1

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.

Time frame
Baseline and monthly assessments during 2-month intervention
2

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.

Time frame
Baseline and monthly assessments during 2-month intervention
3

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.

Time frame
Baseline and monthly assessments during 2-month intervention
4

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).

Time frame
Baseline and monthly assessments during 2-month intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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