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The Effect of the Mobile Application for Caregivers of Patients With Percutaneous Endoscopic Gastrostomy (PEG) on Caregivers

Primary Purpose

Percutaneous Endoscopic Gastrostomy, Caregiver Burden, Mobile Application

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mobile application ( PEG Assist )
Sponsored by
Duzce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Percutaneous Endoscopic Gastrostomy focused on measuring mobile application, Percutaneous endoscopic gastrostomy, caregiver burden

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kocaeli State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

experimental group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2022
Last Updated
September 6, 2023
Sponsor
Duzce University
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1. Study Identification

Unique Protocol Identification Number
NCT05645458
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
November 21, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duzce University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Endoscopic Gastrostomy, Caregiver Burden, Mobile Application
Keywords
mobile application, Percutaneous endoscopic gastrostomy, caregiver burden

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
In addition to maintaining the control group, the experimental group is monitored by installing the mobile application we have developed.
Intervention Type
Other
Intervention Name(s)
mobile application ( PEG Assist )
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caregiver burden
Description
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
Title
competence of caregivers
Description
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
Secondary Outcome Measure Information:
Title
Mobile application satisfaction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atiye Erbaş, PhD
Phone
+905057285837
Email
laybel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hatice eylem Oguz
Phone
+905414092220
Email
eylemmoguz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atiye Erbaş, PhD
Organizational Affiliation
Duzce University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli State Hospital
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatice Eylem Oguz
Phone
905414092220
Email
eylemmoguz@gmail.com
First Name & Middle Initial & Last Name & Degree
Atiye Erbaş, PhD
Phone
+905057285837
Email
laybel@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of the Mobile Application for Caregivers of Patients With Percutaneous Endoscopic Gastrostomy (PEG) on Caregivers

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