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IRCT20210621051651N1 IRCT 2021-07-08 Kashan University of Medical Sciences The effect of smartphone-based self-management application on asthma control The effect of smartphone-based self-management application on asthma control 2021-07-23 anticipated 60 Complete https://irct.ir/trial/57106 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: In this randomized controlled trial study, patients with asthma were divided into two groups of intervention (n = 30) and control (n = 30) by Permuted Block Randomization. In this method, first, all blocks of size 4, which include two codes A and B, are prepared (6 blocks), then, using random numbers table, random blocks are selected by placement (15 blocks). These blocks form a sequence of 60 codes A and B, each of which is randomly assigned to one of the control and intervention groups. It should be noted that the effect of confounding variables will be controlled by the block randomization method. N/A Asthma. Intervention 1: Intervention group: The intervention includes an app designed in a previous study by a team of health information management professionals and asthma and allergy specialists using Adobe Air software under the Android operating system and its usability was successfully evaluated by patients with asthma (n = 30), IT (n = 8) and asthma and allergy specialists (n = 2). This app has various functionalities such as providing educational information, recording information, setting reminders, and communicating with the doctor that helps patients to improve their adherence to treatment and self-care. Intervention 2: Control group: The control group includes patients who receive their usual treatment. Yes - There is a plan to make this available What will be shared: Participants' data files, and statistical analysis will be available in SPSS file format. The clinical study data will be published by the open paper. When: 6 months after study publication To whom: Final results for all people and the data and statistical files on scientific centers request Conditions: Only scientific and academic institutions can request access to data for scientific analysis. Where to obtain: Kashan University of Medical Sciences, Health Information Management and Technology department, Reihane Alsadat Sharif How to obtain: The request must be sent by post to the Department of Health Management and Information Technology of Kashan University of Medical Sciences or to the following email: sharif-rs@kaums.ac.ir Comments:
public Dr. Mehrdad Farzandipour
ًQotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715973449 +98 31 55540021-25 farzandipour_m@kaums.ac.ir Kashan University of Medical Sciences scientific Dr. Marzieh Heidarzadeh Arani
Qotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5554 0026 Marz_heidar@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with asthma at least 18 years old and minimum level of primary education Patients with asthma with a diagnosis of intermittent or persistent asthma approved by a physician. Patients with asthma have a smartphone with an Android operating system that can install the application. 18 years no limit Both Patients with asthma who do not have the knowledge to use a smartphone properly. Patients with other chronic respiratory diseases (except asthma) J45 Asthma Behavior Behavior Intervention group: The intervention includes an app designed in a previous study by a team of health information management professionals and asthma and allergy specialists using Adobe Air software under the Android operating system and its usability was successfully evaluated by patients with asthma (n = 30), IT (n = 8) and asthma and allergy specialists (n = 2). This app has various functionalities such as providing educational information, recording information, setting reminders, and communicating with the doctor that helps patients to improve their adherence to treatment and self-care. Control group: The control group includes patients who receive their usual treatment. Asthma control test score using Asthma Control Test Questionnaire (ACT). Timepoint: Baseline, after three months, after 6 months. Method of measurement: At each visit, patients will complete an asthma control test questionnaire used to assess symptoms. Quality of Life. Timepoint: Baseline, after three months, after 6 months. Method of measurement: At each visit, patients will complete a standard Asthma Quality of Life Questionnaire (AQLQ). Kashan University of Medical Sciences Approved 2021-06-09 Research Ethics Committee of Faculty of Nursing & Midwifery, Faculty of Health & Faculty of Paramedi Qotb-e Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)