Evaluation of the effect of education-based intervention on rate of adherence of patients with suspected sleep apnea to physician's order for sleep test
The aim of this study is evaluation of the effect of education-based intervention on rate of adherence of patients with suspected sleep apnea to physician's order for sleep test.
Design
100 patients among all patients who will visited by related physicians in Isar, Sajjad, and Ebn'e Sina clinics and some physicians’ private practices and meet the entry criteria will be selected and assigned randomly to the intervention and control groups. Educational material required for patients with suspected sleep apnea 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 video and will 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 education-based intervention.
Settings and conduct
Patients who will be visited by related physicians in Isar, Sajjad, and Ebn'e Sina clinics and some physicians’ private practices and meet the entry criteria will be selected and assigned randomly to the intervention and control groups. In this study, the care providers, outcome assessor, and data analyser will not aware of the group to which any patient belongs.
Participants/Inclusion and exclusion criteria
Physician’s order for sleep test and baseline literacy have been considered as major inclusion criteria. Unwillingness to stay in the study has been considered as the major exclusion criterion.
Intervention groups
The intervention group will use a booklet and video containing disease and diagnosis points for a period of one month.
The control group will not receive designed education-based intervention.
Main outcome variables
Referral rate for sleep test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170922036314N3
Registration date:2018-02-09, 1396/11/20
Registration timing:registered_while_recruiting
Last update:2018-02-09, 1396/11/20
Update count:0
Registration date
2018-02-09, 1396/11/20
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
Mashhad University of Medical Sciences
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of education-based intervention on rate of adherence of patients with suspected sleep apnea to physician's order for sleep test
Public title
Evaluation of the effect of education-based intervention on referral rate of patients with suspected sleep apnea for sleep test
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Physician’s order for sleep test
baseline literacy
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
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple randomization; Unit of randomization: individual randomization; the tool use in randomization: sealed envelops; the random sequence will be built using www.randomization.com website
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the care providers, outcome assessor, and data analyser will not aware of the group to which any patient belongs.
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
Province
Razavi Khorasan
Postal code
917-7948-564
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IRCT2017092236314N1
Health conditions studied
1
Description of health condition studied
sleep apnea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnoea
Primary outcomes
1
Description
Referral rate for sleep test
Timepoint
1 month after the intervention
Method of measurement
checklist
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will use a booklet and video containing disease and diagnosis points for a period of one month.
Category
Behavior
2
Description
The control group will not receive designed education-based intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sajjad occupational medicine center
Full name of responsible person
Dr. Lahya Afshari Saleh
Street address
2th East Amin Street, Sajjad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9186600000
Phone
+98 51 3604 4976
Email
AfshariSl@mums.ac.ir
2
Recruitment center
Name of recruitment center
Isar Clinic
Full name of responsible person
Dr. Mahnaz Amini
Street address
Imam Khomeini Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9136900000
Phone
+98 51 3222 1671
Email
AminiM@mums.ac.ir
3
Recruitment center
Name of recruitment center
Ebn'e Sina Hospital
Full name of responsible person
Dr. Hadi Asadpour
Street address
Horeameli Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
AsadpourH@mums.ac.ir
4
Recruitment center
Name of recruitment center
Doctor's office
Full name of responsible person
Dr. Hadi Asadpour
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176600000
Phone
+98 51 3844 0064
Email
AsadpourH@mums.ac.ir
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
Province
Razavi Khorasan
Postal code
917-7948-564
Phone
+98 51 3800 2429
Email
EbrahimzadehF2@mums.ac.ir
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
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
Student Research Committee, Department of Medical Informatics, School of Medicine, Mashhad Universit
Full name of responsible person
Shokoufeh Aalaei
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Building 63, Haft e Tir 2 Street, Haft e Tir BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
9178786379
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
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
917-7948-564
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
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Building 63, Haft e Tir 2 Street, Haft e Tir BLVD
City
Mashhad
Province
Razavi Khorasan
Postal code
9178786379
Phone
+98 51 3882 5632
Fax
Email
aalaeish931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available