Percutaneous Endoscopic Gastrostomy (PEG)PEG-EDUNCT07074301
Training Program for PEG Caregivers: A Structured Intervention Study
A study testing Caregiver Training Program in people with Percutaneous Endoscopic Gastrostomy (PEG) and Training, run by Koç University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Endoscopic Gastrostomy (PEG), Training, Caregiver Burden
- What is being tested?
- Caregiver Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Discharge from hospital or death of the patient during the study period
- Being under 18 years old
- Illiteracy of the caregiver
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Education and Mobile Application for Percutaneous Endoscopic Gastrostomy Care
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.
Read the 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.
- Conditions
- Percutaneous Endoscopic Gastrostomy (PEG), Training, Caregiver Burden, Nutritional Support, Training Effectiveness
- Being tested
- Caregiver Training Program
- Keywords
- Percutaneous endoscopic gastrostomy, Caregiver Burden, Structured Training, Home Enteral Nutrition
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Training Program | Experimental | Caregivers receive a structured education program and mobile application support based on Bandura's Social Learning Theory. Receives: Behavioral: Caregiver Training Program |
| Routine Care | No intervention | Caregivers receive the institution's standard information and support practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and monthly assessments during 2-month intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and monthly assessments during 2-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start5 Sep 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Endoscopic Gastrostomy (PEG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevilay Senol Celik, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074301
- Sponsor's protocol ID
- 2024.389.IRB2.171
- Acronym
- PEG-EDU
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that supports the findings of this study will be available upon reasonable request from researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Education and Mobile Application for Percutaneous Endoscopic Gastrostomy Care
- ClinicalTrials.gov ID
- NCT07074301
- Acronym / sponsor ID
- PEG-EDU / 2024.389.IRB2.171
- Conditions
- Percutaneous Endoscopic Gastrostomy (PEG), Training, Caregiver Burden, Nutritional Support, Training Effectiveness
- Keywords
- Percutaneous endoscopic gastrostomy, Caregiver Burden, Structured Training, Home Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caregiver Training Program | Experimental | Behavioral: Caregiver Training ProgramCaregivers receive a structured education program and mobile application support based on Bandura's Social Learning Theory. |
| Routine Care | No intervention | –Caregivers receive the institution's standard information and support practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Willingness to participate voluntarily in the study
- No communication barriers
- Ability to use a smartphone
- No diagnosed psychiatric disorder
Key exclusion criteria (3 listed)
- Discharge from hospital or death of the patient during the study period
- Being under 18 years old
- Illiteracy of the caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver Training ProgramThe 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. | Behavioural | Caregiver Training Program |
Primary outcome
Change in Caregiver Knowledge Level
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that supports the findings of this study will be available upon reasonable request from researchers.
Related trials for Percutaneous Endoscopic Gastrostomy (PEG)
Not yet recruiting
Caregiver Training Regarding Percutaneous Endoscopic Gastrostomy Feeding and Care
Caregiver, Caregiver Anxiety
Not yet recruitingObservational study
Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families
Intensive Care Unit (ICU) Admission, Tracheostomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Training Program in people with Percutaneous Endoscopic Gastrostomy (PEG) and Training, run by Koç University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevilay Şenol Çelik, Ph.D. (+905356666863, sevilaycelik@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caregiver Knowledge Level (time frame: Baseline and monthly assessments during 2-month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.