The aim of this study is a comparison of the effect of mobile-based and paper-based educational interventions on knowledge of patients with obstructive sleep apnea. Using of any type of positive airway pressure (PAP) device for treatment at the time of the study, baseline literacy, having a smartphone and Lack of some underlying diseases have been considered as major inclusion criteria. Unwillingness to stay in the study have been considered as the major inclusion criterion. 90 patients among all patients who underwent the sleep study in Emam Reza, Ebn'e Sina, and Razavi Hospitals, Roya, and Sabz Darman sleep clinics and meet the entry criteria will be selected and assigned randomly to the intervention and control groups. Educational material required for obstructive sleep apnea patients is provided using the educational resources available in the field of sleep disorders and experts consensus. The provided content is implemented as a booklet and a mobile-based application. The booklet will be provided to all patients and the mobile application will just be provided to patients in the intervention group. A multi-center, double-blinded 2-armed randomized control trial is designed to evaluate the effectiveness of the mobile-based application. Patients’ knowledge as the primary outcome will be evaluated by a questionnaire before and 1 month after intervention. PAP usage will be also assessed as the secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092236314N1
Registration date:2017-10-21, 1396/07/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Shokoufeh Aalaei
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2429
Email address
aalaeish931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of mobile-based and paper-based educational interventions on knowledge of patients with obstructive sleep apnea
Public title
Evaluation of educational interventions on knowledge of patients with obstructive sleep apnea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: All patients with obstructive sleep apnea that use any type of positive airway pressure device; Baseline literacy; having a smartphone (the patient or first-degree relatives); Lack of some underlying diseases such as dementia and visual impairment
Exclusion Criteria: Unwillingness to stay in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine Ethical Committee
Street address
Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IR.MUMS.fm.REC.1395.571
Health conditions studied
1
Description of health condition studied
obstructive sleep apnea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnoea
Primary outcomes
1
Description
patients' knowledge level about disease and treatment
Timepoint
pre intervention, 1 month after the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
PAP (positive airway pressure) usage rate
Timepoint
pre intervention, 1 month after the intervention
Method of measurement
usage data stored on PAP (positive airway pressure) device
Intervention groups
1
Description
The intervention group will use a booklet and a mobile-based application containing disease and treatment points for a period of one month.
Category
Behavior
2
Description
The control group will use a booklet containing educational content for a period of one month.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Mahnaz Amini
Street address
Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
2
Recruitment center
Name of recruitment center
Ebn'e Sina Hospital
Full name of responsible person
Dr. Hadi Asadpour
Street address
Horeameli Avenue, Mashhad, Iran
City
Mashhad
3
Recruitment center
Name of recruitment center
Razavi Hospital
Full name of responsible person
Dr. Hadi Asadpour
Street address
After Qaem Bridge, Azadi Highway ,Mashhad ,Iran
City
Mashhad
4
Recruitment center
Name of recruitment center
Roya sleep clinic
Full name of responsible person
Dr. Hadi Asadpour
Street address
Parastar Street, Mashhad
City
Mashhad
5
Recruitment center
Name of recruitment center
Sabz Darman sleep clinic
Full name of responsible person
Dr. Mehri Sarfarazi
Street address
Kouhsangi Avenue, Mashhad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Ebrahimzadeh
Street address
Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Student Research Committee, Department of Medical Informatics, School of Medicine, Mashhad Universit
Full name of responsible person
Shokoufeh Aalaei
Position
Ph.D student
Other areas of specialty/work
Street address
Building 63, Haft e Tir 2 Street, Haft e Tir BLVD
City
Mashhad
Postal code
Phone
+98 51 3882 5632
Fax
Email
aalaeish931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Departments of Medical Informatics, School of Medicine, Mashhad University of Medical Sciences, Mash
Full name of responsible person
Saeid Eslami
Position
Medical Informatics, Associate Professor
Other areas of specialty/work
Street address
Faculty of Medicine
City
Mashhad
Postal code
Phone
+98 51 3800 2429
Fax
Email
EslamiS@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee, Department of Medical Informatics, School of Medicine, Mashhad Universit
Full name of responsible person
Shokoufeh Aalaei
Position
Ph.D student
Other areas of specialty/work
Street address
Building 63, Haft e Tir 2 Street, Haft e Tir BLVD
City
Mashhad
Postal code
Phone
+98 51 3882 5632
Fax
Email
aalaeish931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)