Clinical trial NCT05645458: The Effect of the Mobile Application for Caregivers of Patients With Percutaneous Endoscopic Gastrostomy (PEG) on Caregivers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Endoscopic Gastrostomy
Caregiver Burden
Mobile Application
Keywords: mobile application
Percutaneous endoscopic gastrostomy
caregiver burden
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* The patient to be cared for has metastatic cancer
* Refusing to participate in the study
* Stop working at any stage of the study

Primary outcomes:
measure: Caregiver burden
timeFrame: one day
measure: competence of caregivers
timeFrame: one day
Secondary outcomes:
measure: Mobile application satisfaction
timeFrame: one day
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli State Hospital
Study officials:
affiliation: Duzce University
name: Atiye Erbaş, PhD
role: PRINCIPAL_INVESTIGATOR
References: