The effect of a smartphone-based asthma self-management app on asthma control
Design
A clinical trial study with an intervention and control group, with parallel, randomized groups on 60 patients. For randomization, the block randomization method with placement will be used.
Settings and conduct
The study population was patients with asthma referred to the only subspecialty clinic for asthma and allergies in Kashan, Iran. The application (app) will be installed on the smartphone of asthma patients in the intervention group, and a complete description of how to use the app will be provided to them by the physician. All patients are evaluated and trained in the inhalation technique at the beginning of the study (T0) and receive an action plan. After starting the study, patients are called to the clinic every 3 and 6 months (T1 and T2) to evaluate the outcomes.
Participants/Inclusion and exclusion criteria
Patients with asthma have a smartphone with a minimum age of 18 years and at least primary education and a diagnosis of intermittent or persistent asthma were included in the study and patients with other chronic respiratory diseases were excluded.
Intervention groups
The control group includes patients who receive their usual treatment, and the intervention group uses a smartphone-based application in addition to the usual treatment.
Main outcome variables
Asthma control test score and quality of life score of patients with asthma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210621051651N1
Registration date:2021-07-08, 1400/04/17
Registration timing:prospective
Last update:2021-07-08, 1400/04/17
Update count:0
Registration date
2021-07-08, 1400/04/17
Registrant information
Name
Reihane alsadat Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5531 1454
Email address
sharif-rs@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of smartphone-based self-management application on asthma control
Public title
The effect of smartphone-based self-management application on asthma control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Patients with asthma who do not have the knowledge to use a smartphone properly.
Patients with other chronic respiratory diseases (except asthma)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Faculty of Nursing & Midwifery, Faculty of Health & Faculty of Paramedi
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1400.010
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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).
Intervention groups
1
Description
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.
Category
Behavior
2
Description
Control group: The control group includes patients who receive their usual treatment.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Marzieh Heidarzadeh Arani
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0026
Email
Marz_heidar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafsheh
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Farzandipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Information Management
Street address
ًQotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 55540021-25
Email
farzandipour_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Marzieh Heidarzadeh Arani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0026
Email
Marz_heidar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Reihane Alsadat Sharif
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Health Information Management
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5554 0021
Email
sharif-rs@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
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 the data will become available and for how long
6 months after study publication
To whom data/document is available
Final results for all people and the data and statistical files on scientific centers request
Under which criteria data/document could be used
Only scientific and academic institutions can request access to data for scientific analysis.
From where data/document is obtainable
Kashan University of Medical Sciences, Health Information Management and Technology department, Reihane Alsadat Sharif
What processes are involved for a request to access data/document
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