Clinical trial NCT05428618: Mobile Application for Bariatric Surgery Patients
Official title: The Effect of Mobile Support Application Developed for Patients Undergoing Bariatric Surgery on Self-Management, Quality of Life and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bariatric Surgery
Quality of Life
Complication
Mobile Health
EHealth
Self Management
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Antalya Training and Research Hospital
First posted: 2022-06-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Self-Management
timeFrame: Change from baseline BBSQ at one month, Change from baseline BBSQ at 3 months, Change from baseline BBSQ at 6 months
measure: Quality of Life Scale
timeFrame: 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:
measure: Weight loss
timeFrame: 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
measure: Nausea
timeFrame: 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
measure: Vomiting
timeFrame: 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
measure: Dizziness
timeFrame: 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
measure: Pain-Visual Analog Scale
timeFrame: 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
measure: wound infection
timeFrame: Change from baseline Visual Analog Scale (VAS) for wound infection at one month.
measure: Hypoglycemia
timeFrame: Change from baseline Visual Analog Scale (VAS) for hypoglycemia at one month, Change from one month VAS for hypoglycemia at 3 months, Change from 3 months VAS for hypoglycemia at 6 months.
measure: Constipation
timeFrame: Change from baseline Visual Analog Scale (VAS)for constipation at one month, Change from one month VAS for constipation at 3 months, Change from 3 months VAS for constipation at 6 months.
measure: Number of emergency admissions
timeFrame: Change from baseline Number of emergency admissions at one month, Change from one month number of emergency admissions at 3 months, Change from 3 months number of emergency admissions at 6 months.
measure: Number of hospital readmission
timeFrame: Change from baseline number of hospital readmission at one month, Change from one month number of hospital readmission at 3 months, Change from 3 months number of hospital readmission at 6 months.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya
city: Antalya
country: Turkey
facility: Hospital
Study officials:
References: