The purpose of this study was to determine the effect of motivational interview on adherence to treatment, self-efficacy and self-management in adolescents with asthma.
Design
In this research, 72 adolescents with asthma who are eligible for inclusion in the study will be selected and will be randomly assigned to two groups of test and control, and will be assigned a unique code to each participants.
Settings and conduct
AAfter sampling from Vali-e-Asr Hospital clinic and obtaining written consent from parents,for both groups will be completed demographic information and medical adherence questionnaire, self-efficacy and asthma self-management questionnaire.the intervention group is then randomly divided into three subgroups of 12 people and a motivational interview will be conducted in 5 weeks and one week each week.and the control group will not receive any intervention.after and three months after the intervention, will be completed the Asthma adherence and self-management and self-management Questionnaire.
Participants/Inclusion and exclusion criteria
Diagnosis of asthma from a year ago or more by a specialist physician; being at the age of 9-15 years
Intervention groups
In the intervention group, the motivational interview will be conducted in accordance with the Miller and Ronik principles in 5 sessions. The structure of weekly meetings from a group intervention book will be derived from a five-session motivational interview.
The control group will not receive any intervention.
Main outcome variables
Main outcome variables: Adherence to therapy, self-efficacy and self-management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170902036026N3
Registration date:2018-01-27, 1396/11/07
Registration timing:retrospective
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Fatemeh Taheri
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3245 0499
Email address
f.taheri@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Birjand University of Medical Sciences
Expected recruitment start date
2016-10-24, 1395/08/03
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to study the effect of motivational interview on adherence to therapy, self-efficacy and self-management in adolescents with asthma
Public title
The Effect of Motivational Interveiwing on treatment adherence , self-efficasy and self-management among adolescents whit asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Asthma diagnosis from one year or more by a specialist
Parent's informed consent and person's willingness to participate in the study
Having a 9-15 age
Having reading and writing skills
Using at least one inhaler
Exclusion criteria:
Having no mental problems
Age
From 9 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is that a number is chosen between 1 and 10 in a draw and placed in the intervention group, then will be placed every other individual into two groups.
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
Ethics committee of Birjand University of Medical Sciences
Street address
University of Medical Sciences,Ghaffari Street,Birjand
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2016-11-28, 1395/09/08
Ethics committee reference number
IR.BUMS.NEC.1395179
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.9
ICD-10 code description
Asthma, unspecified
Primary outcomes
1
Description
Adherence to Therapy
Timepoint
Before intervention, After intervention, three months after intervention
Method of measurement
Self-Reporting Questionnaire on Adherence to Therapy and Asthma Control
2
Description
Self-Efficacy
Timepoint
Before intervention, after intervention, three months after intervention
Method of measurement
Asthma Self-Efficacy Questionnaire
3
Description
Self-management
Timepoint
Before intervention, After intervention, three months after intervention
Method of measurement
Self-Management 21 Item Questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: The motivational interview will be conducted in accordance with the Miller and Runic principles in 5 sessions. the structure of weekly meetings will be extracted from a motivational interviewing group intervention book with a five-session structure.
Category
Behavior
2
Description
Control group: no intervention will be received
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Fatemeh Taheri
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3162 2217
Fax
Email
f.taheri@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Tuba Kazemi
Street address
Research and Technology Deputy, Third Floor of Education and Research Building, University of Medical Sciences,Birjand,Iran
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Birjand 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
Valiasr Hospital
Full name of responsible person
Fatemeh taheri
Position
Nurs
Latest degree
Master
Other areas of specialty/work
Street address
Vali Asr Hospital, Ghafari St, Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3245 0499
Fax
Email
f.taheri@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing School
Full name of responsible person
Ahmad Nasiri
Position
Ph.D. in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Faculty of Nursing, Ghaffari St, Birjand
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1406
Fax
Email
ah.nasiri@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fatemeh Taheri
Position
Student
Latest degree
Master
Other areas of specialty/work
Street address
Faculty of Nursing, Birjand University of Medical Sciences, Ghaffari St., Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3245 0499
Fax
Email
f.taheri@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main consequence
When the data will become available and for how long
One year after the results' publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
It is not allowed to do any analyzes on the data
From where data/document is obtainable
f.taheri@bums.ac.ir
What processes are involved for a request to access data/document