Mobile Application for Bariatric Surgery Patients

NCT ID: NCT05428618

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-07-01

Brief Summary

Introduction: One of the alternative ways, as a result of the increasing demand for health services and the inadequacy of meeting the increasing needs, is mobile health applications. According to TUIK 2019 data, the rate of having mobile phones in households is 98.7%. With the development of technology, all information can be integrated into the mobile phone, and mobile applications allow the patient to give data from the environment in which he lives and to evaluate himself. Self-assessment and monitoring of the patient enable the patient to participate in his/her self-care, supports self-management behaviors, and improves their quality of life.

Objective: It was aimed to develop a mobile support application for patients undergoing bariatric surgery and to evaluate the effect of application use on patients' self-management, quality of life, and clinical outcomes.

Method: In the first stage;

• Preparing the information to be included in the mobile health application that is planned to be developed and evaluating the quality of the content,
• Parallel to this, the adaptation of the "Bariatric Surgery Self-Management Behaviors Scale" into Turkish and the evaluation of its validity and reliability.
• Design of the mobile application, transferring the educational content to the mobile application,
• It is aimed to evaluate the technical suitability and usability of the mobile application.

In the second stage, it was aimed to conduct a randomized controlled study to determine the effect of the developed mobile application on the self-management, quality of life and clinical outcomes of the patients.

The developed mobile application will be introduced to patients at discharge after bariatric surgery. Rating scales will be administered to patients at the end of one, three, and six months after surgery. These scales are the Bariatric Surgery Self-Management Behaviors Scale and the Moorehead-Ardelt Quality of Life Scale-II.

Conclusion: It is expected that the mobile application-based education to be developed for bariatric surgery will improve the patients' post-surgical self-management, increase their quality of life and decrease the early complication rates.

Conditions

Obesity; Bariatric Surgery; Quality of Life; Complication; Mobile Health; EHealth; Self Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

e-BariS app Group

"Self-Monitoring Module" and "Patient Education Module"

Group Type: EXPERIMENTAL

e-BariS app group

Intervention Type: OTHER

During the discharge process, informed consent will be obtained from the patients and the measurement tools will be filled and the mobile application will be downloaded to their phones. The intervention group will have access to all the content of the mobile application, which includes the "Self-Monitoring Module" and the "Patient Education Module". Passwords will be defined so that patients in the intervention group can access the "Patient Education Module". Information on the introduction and use of the application will be presented to the patient by the researcher.

The patients will be followed for six months within the scope of the project. In addition, reminder notifications will be sent to patients via the mobile application in line with the areas that patients can access. At one, three, and six months after surgery, he will complete other assessment scales during outpatient follow-up. For patients providing remote control, the scale will be sent online.

Self-Monitoring Group

"Self-Monitoring Module"

Group Type: SHAM_COMPARATOR

Self-Monitoring Group

Intervention Type: OTHER

Patients in the control group will only have access to the "Self-Monitoring Module" in the application. Other fields will be encrypted. Patients in the control group will also be informed about the area they can access. Patients in the control group will only have access to the self-monitoring section. One, three, and six months after surgery, she will complete other assessment scales during her outpatient follow-up. Scales will be sent online for patients providing remote control. After the project is completed, all content will be opened to the control group patients.

Interventions

e-BariS app group

During the discharge process, informed consent will be obtained from the patients and the measurement tools will be filled and the mobile application will be downloaded to their phones. The intervention group will have access to all the content of the mobile application, which includes the "Self-Monitoring Module" and the "Patient Education Module". Passwords will be defined so that patients in the intervention group can access the "Patient Education Module". Information on the introduction and use of the application will be presented to the patient by the researcher.

The patients will be followed for six months within the scope of the project. In addition, reminder notifications will be sent to patients via the mobile application in line with the areas that patients can access. At one, three, and six months after surgery, he will complete other assessment scales during outpatient follow-up. For patients providing remote control, the scale will be sent online.

Intervention Type: OTHER

Self-Monitoring Group

Patients in the control group will only have access to the "Self-Monitoring Module" in the application. Other fields will be encrypted. Patients in the control group will also be informed about the area they can access. Patients in the control group will only have access to the self-monitoring section. One, three, and six months after surgery, she will complete other assessment scales during her outpatient follow-up. Scales will be sent online for patients providing remote control. After the project is completed, all content will be opened to the control group patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Speaking and understanding Turkish,
• Being literate
• Having the ability to use a smartphone,
• Having a mobile phone with IOS or Android software,
• Having internet access,
• Having consented to download the mobile application to the mobile phone,
• Between the ages of 18-65,
• Patients undergoing bariatric surgery for the first time.

Exclusion Criteria

• Patients with vision or hearing problems

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Damla Seckin

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Antalya

Antalya, , Turkey (Türkiye)

Hospital

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

w34dsxfh

Identifier Type: -

Identifier Source: org_study_id