Dataset Information

Smartphone Application for Celiac Patients: Assessing Its Effect on Gastrointestinal Symptoms in a Randomized Controlled Clinical Trial.

ABSTRACT:

Introduction

Considering the lack of inclusive Persian application for celiac patients that covers all aspects of the GFD, we developed a Persian-language application for patients with CD and assessed the effectiveness of a three-month educational intervention delivered via smartphone application compared with standard care on gastrointestinal symptom rating scale (GSRS) score in patients with celiac disease.

Methods

In the present parallel randomized controlled clinical trial, 60 patients with CD were assigned randomly to receive education through a smartphone application (n = 30) or conventional clinical education (n = 30). The patients were asked to use it for getting the required information for three months. We assessed the gastrointestinal symptoms using the gastrointestinal symptom rating scale (GSRS) questionnaire at baseline and three months after interventions. The GSRS total score, celiac disease GSRS (CD-GSRS) score, abdominal pain, reflux, diarrhea, constipation, and indigestion scores were calculated.

Results

Out of 60 randomized patients, 58 patients completed the study. In comparison to baseline, the mean score of CD-GSRS score (p = 0.001), and indigestion subscore (p < 0.001) were significantly decreased in the intervention group. The results of the between-group comparisons showed that there was a significant difference between the two groups only in the mean score of indigestion (p = 0.002).

Conclusion

According to the results, using a smartphone application for providing information to patients with celiac disease had a significant positive effect on indigestion symptoms compared with routine clinic education. Trial Registration. This trial is registered with the Iranian registry of clinical trials (IRCT code: IRCT20170117032004N2; trial registry date: 2019.6.26).

SUBMITTER: Nikniaz Z

PROVIDER: S-EPMC9286948 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Smartphone Application for Celiac Patients: Assessing Its Effect on Gastrointestinal Symptoms in a Randomized Controlled Clinical Trial.

Nikniaz Zeinab Z Namvar Zahra Akbari ZA Shirmohammadi Masood M Maserat Elham E

International journal of telemedicine and applications 20220708

<h4>Introduction</h4>Considering the lack of inclusive Persian application for celiac patients that covers all aspects of the GFD, we developed a Persian-language application for patients with CD and assessed the effectiveness of a three-month educational intervention delivered via smartphone application compared with standard care on gastrointestinal symptom rating scale (GSRS) score in patients with celiac disease.<h4>Methods</h4>In the present parallel randomized controlled clinical trial, 60 ...[more]

PMID: 35846977

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Project description:BackgroundDepression is the most prevalent mental disorder, with detrimental effects on the patient's well-being, high disability, and a huge associated societal and economic cost. There are evidence-based treatments, but it is difficult to reach all people in need. Internet-based interventions, and more recently smartphone-based interventions, were explored to overcome barriers to access. Evidence shows them to be effective alternatives to traditional treatments. This paper presents the protocol of a pilot study whose primary aim is to investigate the efficacy of a smartphone-based serious game intervention for patients with mild to moderate depressive symptoms.MethodsThis randomized controlled pilot trial protocol foresees two arms design: 1/ smartphone- based serious game intervention (based on Cognitive Behavior Therapy with particular emphasis on Behavioral Activation and Physical Activity), 2/ waiting list control group. The study is expected to recruit 40 participants (18+), which will be randomly assigned to one of the experimental conditions. The duration of the intervention is two months. The primary outcome measure will be depressive symptomatology. Secondary outcomes will include other variables such as physical activity, resilience, anxiety, depression impairment, and positive and negative affect. Treatment expectation, satisfaction, usability, and game playability will also be measured. The data will be analyzed based on the intention-to-treat and per protocol analyses.DiscussionThe study aims to establish initial evidence for the efficacy of a smartphone-based serious game intervention, to serve as input for a larger-scale randomized control trial. The intervention exploits advanced smartphone capabilities, such as the use of a serious game as delivery mode, with the potential benefit of engagement and treatment adherence, and motion sensors to monitor and stimulate physical activity. As a secondary objective, the study aims to gather initial evidence on the user's expectations, satisfaction, usability and playability of the serious game as a treatment.

Dataset Information

Smartphone Application for Celiac Patients: Assessing Its Effect on Gastrointestinal Symptoms in a Randomized Controlled Clinical Trial.

Introduction

Methods

Results

Conclusion

Publications

Smartphone Application for Celiac Patients: Assessing Its Effect on Gastrointestinal Symptoms in a Randomized Controlled Clinical Trial.

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