An interventional study of mobile application ( PEG Assist ) in Percutaneous Endoscopic Gastrostomy, Caregiver Burden and Mobile Application, sponsored by Duzce University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Duzce University · Not applicable, Interventional, and Supportive care
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.
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:
422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.
This study's enrollment of 27 is below the median of 73 across 330 interventional studies indexed under Caregiver Burden.
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Exclusion Criteria:
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.
In addition to maintaining the control group, the experimental group is monitored by installing the mobile application we have developed.
Other: 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.
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.
Time frame: 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.
Time frame: one day
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
Time frame: one day
Plan to share: No
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