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

NCT05645458 | Completed

• 1 other identifier: duzceUatiye-3
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Endoscopic Gastrostomy; Caregiver Burden; Mobile Application

Keywords

mobile application; Percutaneous endoscopic gastrostomy; caregiver burden

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  one day

Secondary Outcomes (1)

• Mobile application satisfaction

  one day

Study Arms (2)

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.

Other: mobile application ( PEG Assist )

Interventions

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Kocaeli State Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Atiye Erbaş, PhD

  Duzce University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 9, 2022
• Study Start: November 21, 2022
• Primary Completion: November 21, 2023
• Study Completion: June 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)