Mobile Application for Bariatric Surgery Patients

NCT05428618 | Completed

• 1 other identifier: w34dsxfh
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Self-Management

  The self-management scores of the patients will be measured with the Bariatric Surgery Self-Management Behaviors Scale. The scale was developed by Welch and colleagues in 2008. Validity and reliability were done in Iran in 2018. It consists of seven factors and 33 items, including eating behaviors (8), fluid intake (8), physical activity (3), dumping syndrome management (4), vitamin and mineral supplement (4), fruit, vegetable, and cereals (3), protein intake (3). It is evaluated with a triple Likert scale as never, sometimes, and always. Subscale and total scores were converted to the range of 0-100, higher scores indicate higher self-management.

  Change from baseline BBSQ at one month, Change from baseline BBSQ at 3 months, Change from baseline BBSQ at 6 months

• Quality of Life Scale

  The Moorehead-Ardelt Quality of Life Scale (MA-II) was developed in 1998. The scale consists of six questions including self-esteem, physical function, social relations, ability to work, sexuality, and eating behavior. At the same time, each item of the scale is supported by figures related to the subject in order to help individuals from different cultures understand. Each item has a 10-point Likert-type measure. Each item is equally weighted and increases and decreases by 0.10 points positively and negatively, keeping the 0 value in the center. While each item decreases by 0.10 points from the "0" point to the left, it increases by 0.10 points to the right. The scores for each item range from -0.50 to 0.50. The total scale scoring varies between -3 and +3, the score between -2.1 and -3 is considered a very poor quality of life, and between +2.1 and +3, the quality of life is considered.

  Change from baseline MA-II at one month, Change from baseline MA-II at 3 months, Change from baseline MA-II at 6 months

Secondary Outcomes (10)

• Weight loss

  Change from baseline kilogram for weight loss at one month, Change from baseline kilogram for weight loss at 3 months, Change from baseline kilogram for weight loss at 6 months

• Nausea

  Change from baseline Visual Analog Scale (VAS) for nausea at one month, Change from one month VAS for nausea at 3 months, Change from 3 months VAS for nausea at 6 months

• Vomiting

  Change from baseline Visual Analog Scale (VAS) for vomiting at one month, Change from one month VAS for vomiting at 3 months, Change from 3 months VAS for vomiting at 6 months

• Dizziness

  Change from baseline Visual Analog Scale (VAS) for dizziness at one month, Change from one month VAS for dizziness at 3 months, Change from 3 months VAS for dizziness at 6 months

• Pain-Visual Analog Scale

  Change from baseline Visual Analog Scale (VAS) for pain at one month, Change from one month VAS for pain at 3 months, Change from 3 months VAS for pain at 6 months

Study Arms (2)

e-BariS app Group

EXPERIMENTAL

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

Other: e-BariS app group

Self-Monitoring Group

SHAM COMPARATOR

"Self-Monitoring Module"

Other: Self-Monitoring Group

Interventions

e-BariS app group 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.

e-BariS app Group

Self-Monitoring Group 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.

Self-Monitoring Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with vision or hearing problems

Sponsors & Collaborators

• Akdeniz University: lead
• Antalya Training and Research Hospital: collaborator

Study Sites (2)

Antalya

Antalya, Turkey (Türkiye)

Location

Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: June 23, 2022
• Study Start: September 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 7, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)