The Effect of Mobile Support Application Developed for Patients Undergoing Bariatric Surgery on Self-Management, Quality of Life and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Quality of Life Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patients with vision or hearing problems
研究组 & 干预措施
e-BariS app Group
"Self-Monitoring Module" and "Patient Education Module"
干预措施: e-BariS app group (Other)
Self-Monitoring Group
"Self-Monitoring Module"
干预措施: Self-Monitoring Group (Other)
结局指标
主要结局
Quality of Life Scale
时间窗: Change from baseline MA-II at one month, Change from baseline MA-II at 3 months, Change from baseline MA-II at 6 months
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.
Self-Management
时间窗: Change from baseline BBSQ at one month, Change from baseline BBSQ at 3 months, Change from baseline BBSQ at 6 months
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.
次要结局
- 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)
- wound infection(Change from baseline Visual Analog Scale (VAS) for wound infection at one month.)
- Hypoglycemia(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.)
- Constipation(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.)
- 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)
- Number of emergency admissions(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.)
- Number of hospital readmission(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.)
研究者
Damla Seckin
Research Assistant
Akdeniz University