Percutaneous Endoscopic GastrostomyNCT05645458
The Effect of the Mobile Application for Caregivers of Patients With Percutaneous Endoscopic Gastrostomy (PEG) on Caregivers
A study testing mobile application ( PEG Assist ) in people with Percutaneous Endoscopic Gastrostomy and Caregiver Burden, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: In order to benefit from the opportunity of education anytime and anywhere with distance education, individuals need to use mobile devices such as mobile phones, tablets, PCs, which provide the opportunity to access educational content independent of time and place. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Endoscopic Gastrostomy, Caregiver Burden, Mobile Application
- What is being tested?
- mobile application ( PEG Assist )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being the first to care for a patient with PEG at Kocaeli State Hospital or Kocaeli University Hospital
- Be able to read and write
- Not have any physical or psychological disability
- Being able to use a mobile application compatible phone or tablet
- Volunteering to work
Who cannot join
- The patient to be cared for has metastatic cancer
- Refusing to participate in the study
- Stop working at any stage of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Mobile Application for Caregivers of Patients With Percutaneous Endoscopic Gastrostomy (PEG) on the Competence, Satisfaction and Care Burden of Caregivers
- Brief Summary: In order to benefit from the opportunity of education anytime and anywhere with distance education, individuals need to use mobile devices such as mobile phones, tablets, PCs, which provide the opportunity to access educational content independent of time and place. For these reasons, new searches for the delivery of health services are on the agenda and mobile health applications are seen as a solution to most problems faced by the health system and hospitals.
Percutaneous endoscopic gastrostomy (PEG) is a nutritional method that was first described by Gauder et al. in 1980 and is used in patients with impaired oral intake and intact gastrointestinal tract for various reasons. Caregivers play an important role in the home care process of patients undergoing PEG. Caregivers may encounter social, physical and psychological problems while applying their care. In line with all these reasons, the training to be given to the patient or his/her relative/person who will perform the PEG implantation is very important.
Aim: The aim of this study is to evaluate the effect of mobile application use in training given to caregivers of patients with PEG on the competence, satisfaction and care burden of caregivers.
Read the detailed description
Method: Pre-tests will be applied to the caregiver before the patient is discharged, and the first data will be obtained by observing during PEG care. Then, traditional training on PEG care will be given to the relatives of the patients. The tests applied after this training will be applied again.
Your assignments to the research groups that will be formed after the training will be randomly assigned. In this method, which group you will be in will be determined by the computer with the random assignment method. In the experimental design of the research, a random design with a pretest-posttest control group will be applied. The data obtained will be evaluated with intention-to-treat analysis in case of death of the patient who stopped working for any reason after starting the research, started feeding with a method other than PEG, or was cared for.After randomization, the participant in the experimental group will be taught to use the mobile application by the researcher. Tests and observation form will be applied to both groups in the 1st and 3rd months after discharge. By making a home visit to the participant, the recording will be video-recorded so that his identity will not be seen while he is doing PEG care, and the recording will be transcribed to the observation form by 2 blinded people other than the researcher. In the experimental design of the research, a random design with pretest-posttest control group will be applied. In our study, all initiatives except the mobile application were designed to be the same in both groups.
Data accumulation methods:
- Mobile app usability scale, Mobile app usage loyalty scale and app use willingness scale
- Mobile application evaluation form
- PEG care competency form
- Maintenance load scale
- Percutaneous Endoscopic Gastrostomy (PEG) Care Observation Form Mobile application: There are two different types of users in the mobile application we have developed. The first user is the user who manages the application and will see the statistics of the entered data. The second user is the user who will provide data entry to the application and care for the patient. After the caregiver downloads and logs in the application, they will be able to save and use the information about their patient. In our application, there is a panel with general information and panels on nutrition, drug administration and stoma care. Caregivers will be able to access information and videos by entering here. In addition, the application will be able to remind some situations such as feeding times by sending notifications according to the patient data entered at the beginning. Apart from these, the thought and caregivers who have a platform where they can consult the nurse will be able to consult the assistant researcher when something is on their minds.
- Being tested
- mobile application ( PEG Assist )
- Keywords
- mobile application, Percutaneous endoscopic gastrostomy, caregiver burden
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile application ( PEG Assist )Other
The mobile application is used for PEG care. İt gives some information to caregivers related to PEG, PEG care, etc. Also, the researcher can monitor all feeding times with this application.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Pre-tests will be applied to the caregiver before the patient is discharged, and the first data will be obtained by observing during PEG care. Then, traditional training on PEG care will be given to the patient's relatives. The tests applied after this training will be applied again. Tests and observation forms will be applied in the 1st month and 3rd month after discharge. By making home visit the participant, recording will be video-recorded so that his identity will not be seen while he is doing PEG care, and the recording will be transcribed to the observation form by 2 blinded people other than the researcher. |
| experimental group | Experimental | In addition to maintaining the control group, the experimental group is monitored by installing the mobile application we have developed. Receives: Other: mobile application ( PEG Assist ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver burden
The Zarit Caregiver Burden Scale is used to measure caregiver burden. The scale, which is used to determine the effect of caregiving on the individual's life, can be filled by the caregivers themselves or the researcher. It is a five-point Likert type (0 = never, 4 = almost always) and consists of 22 statements. Evaluation of ZBYS is made over the total score. The higher the score, the higher the care burden. A minimum of 0 and a maximum of 88 points are obtained from the scale. Received points; It is evaluated by grading as (0-20) little/no load, (21-40) moderate load, (41-60) severe load, and (61-88) overload.
Measured: one day
competence of caregivers
We use two different form to measure caregiver competence.
First form is an observation form : This form include was developed by researcher. The participants will be video-recorded in a way that their identity will not be seen while they are doing percutaneous endoscopic gastrostomy care by making a home visit, and the recording will be transcripted to the observation form prepared by the researcher (by 2 people who were blinded except the researcher).
the second form is the information form: we use this form to measure the information level of the caregiver. this form includes 25 questions related to PEG care. We will compare all participants according to total scores.
Measured: one day
Secondary outcomes (1)
Mobile application satisfaction
We use two different forms to measure mobile application satisfaction level
The first form satisfaction form was created by the researchers in the form of 4 open-ended questions in order to determine the satisfaction of the mobile application user with the application.
The second form measures mobile application usability. We will use the Mobile application usability scale/ Mobile application usage loyalty scale and mobile application usage willingness scale developed by Hoehle, Aljafari (2016) et al. Turkish validity and reliability of the scales developed by Güler (2019). The scales are 7-point Likert type and the mobile application usability scale consists of 40 items in total with 10 factors, the Mobile Application Usage Loyalty scale consists of a total of 5 items with a single factor, and the mobile application willingness to use scale consists of 6 items with a single facto
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start21 Nov 2022
- Primary completion21 Nov 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Endoscopic GastrostomyStudies 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
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atiye Erbaş, PhD, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645458
- Sponsor's protocol ID
- duzceUatiye-3
- Status last verified
- Jul 2024
- First submitted
- 2 Dec 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mobile Application for Caregivers of Patients With Percutaneous Endoscopic Gastrostomy (PEG) on the Competence, Satisfaction and Care Burden of Caregivers
- ClinicalTrials.gov ID
- NCT05645458
- Acronym / sponsor ID
- duzceUatiye-3
- Keywords
- mobile application, Percutaneous endoscopic gastrostomy, caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Dec 2022 (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.
- Brief Summary: In order to benefit from the opportunity of education anytime and anywhere with distance education, individuals need to use mobile devices such as mobile phones, tablets, PCs, which provide the opportunity to access educational content independent of time and place. For these reasons, new searches for the delivery of health services are on the agenda and mobile health applications are seen as a solution to most problems faced by the health system and hospitals.
Percutaneous endoscopic gastrostomy (PEG) is a nutritional method that was first described by Gauder et al. in 1980 and is used in patients with impaired oral intake and intact gastrointestinal tract for various reasons. Caregivers play an important role in the home care process of patients undergoing PEG. Caregivers may encounter social, physical and psychological problems while applying their care. In line with all these reasons, the training to be given to the patient or his/her relative/person who will perform the PEG implantation is very important.
Aim: The aim of this study is to evaluate the effect of mobile application use in training given to caregivers of patients with PEG on the competence, satisfaction and care burden of caregivers.
Detailed description
Method: Pre-tests will be applied to the caregiver before the patient is discharged, and the first data will be obtained by observing during PEG care. Then, traditional training on PEG care will be given to the relatives of the patients. The tests applied after this training will be applied again.
Your assignments to the research groups that will be formed after the training will be randomly assigned. In this method, which group you will be in will be determined by the computer with the random assignment method. In the experimental design of the research, a random design with a pretest-posttest control group will be applied. The data obtained will be evaluated with intention-to-treat analysis in case of death of the patient who stopped working for any reason after starting the research, started feeding with a method other than PEG, or was cared for.After randomization, the participant in the experimental group will be taught to use the mobile application by the researcher. Tests and observation form will be applied to both groups in the 1st and 3rd months after discharge. By making a home visit to the participant, the recording will be video-recorded so that his identity will not be seen while he is doing PEG care, and the recording will be transcribed to the observation form by 2 blinded people other than the researcher. In the experimental design of the research, a random design with pretest-posttest control group will be applied. In our study, all initiatives except the mobile application were designed to be the same in both groups.
Data accumulation methods:
- Mobile app usability scale, Mobile app usage loyalty scale and app use willingness scale
- Mobile application evaluation form
- PEG care competency form
- Maintenance load scale
- Percutaneous Endoscopic Gastrostomy (PEG) Care Observation Form Mobile application: There are two different types of users in the mobile application we have developed. The first user is the user who manages the application and will see the statistics of the entered data. The second user is the user who will provide data entry to the application and care for the patient. After the caregiver downloads and logs in the application, they will be able to save and use the information about their patient. In our application, there is a panel with general information and panels on nutrition, drug administration and stoma care. Caregivers will be able to access information and videos by entering here. In addition, the application will be able to remind some situations such as feeding times by sending notifications according to the patient data entered at the beginning. Apart from these, the thought and caregivers who have a platform where they can consult the nurse will be able to consult the assistant researcher when something is on their minds.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Pre-tests will be applied to the caregiver before the patient is discharged, and the first data will be obtained by observing during PEG care. Then, traditional training on PEG care will be given to the patient's relatives. The tests applied after this training will be applied again. Tests and observation forms will be applied in the 1st month and 3rd month after discharge. By making home visit the participant, recording will be video-recorded so that his identity will not be seen while he is doing PEG care, and the recording will be transcribed to the observation form by 2 blinded people other than the researcher. |
| experimental group | Experimental | Other: mobile application ( PEG Assist )In addition to maintaining the control group, the experimental group is monitored by installing the mobile application we have developed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being the first to care for a patient with PEG at Kocaeli State Hospital or Kocaeli University Hospital
- Be able to read and write
- Not have any physical or psychological disability
- Being able to use a mobile application compatible phone or tablet
- Volunteering to work
Key exclusion criteria (3 listed)
- The patient to be cared for has metastatic cancer
- Refusing to participate in the study
- Stop working at any stage of the study
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 |
|---|---|---|
| mobile application ( PEG Assist )The mobile application is used for PEG care. İt gives some information to caregivers related to PEG, PEG care, etc. Also, the researcher can monitor all feeding times with this application. | Other | experimental group |
Primary outcome
Caregiver burden
Time frame: one day
The Zarit Caregiver Burden Scale is used to measure caregiver burden. The scale, which is used to determine the effect of caregiving on the individual's life, can be filled by the caregivers themselves or the researcher. It is a five-point Likert type (0 = never, 4 = almost always) and consists of 22 statements. Evaluation of ZBYS is made over the total score. The higher the score, the higher the care burden. A minimum of 0 and a maximum of 88 points are obtained from the scale. Received points; It is evaluated by grading as (0-20) little/no load, (21-40) moderate load, (41-60) severe load, and (61-88) overload.
competence of caregivers
Time frame: one day
We use two different form to measure caregiver competence. First form is an observation form : This form include was developed by researcher. The participants will be video-recorded in a way that their identity will not be seen while they are doing percutaneous endoscopic gastrostomy care by making a home visit, and the recording will be transcripted to the observation form prepared by the researcher (by 2 people who were blinded except the researcher). the second form is the information form: we use this form to measure the information level of the caregiver. this form includes 25 questions related to PEG care. We will compare all participants according to total scores.
1 secondary outcome
Mobile application satisfaction
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Atiye Erbaş, PhD principal investigator
Duzce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application ( PEG Assist ) in people with Percutaneous Endoscopic Gastrostomy and Caregiver Burden, run by Duzce University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver burden (time frame: one day). The study lists 2 primary outcomes in all. 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 3 Jul 2024.