Determining the Impact of Interview on Drug Belief, Self-Efficiency and Adherence to Drug Adolescents with Asthma
Design
The research method is block random assignment in two groups of intervention and control. For this purpose blocks of size 4 will be used. To create a random sequence, the randomizer.org website will be used to hide the random allocation, and the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, the sample for the first sample of the envelope number one is opened and the group will be identified until the end.
After sampling and determining the group, each of the specimens is performed in the first pre-test session and scheduling intervention sessions for that sample if it is part of the intervention group. Patients in the intervention group will receive motivational interviews in four sessions of 40 to 60 minutes, individually per week based on the protocol described (for each motivational interview session). Session 1: Patient Assessment, Second Session: Interview with Patient in Connection with Environmental and External Barriers to Drug Abuse, Third Session: Interview with Patient in Connection with Individual and Internal Barriers to Drug Abuse, Session Four: Promoting Self-Efficacy Levels The client All interviews are conducted by a qualified person who has received the necessary training in this regard. The interviewer will use books, articles and CDs to improve his skill and experience in the field of motivational interviewing, but if the sample is in the control group, it will only run a pre-test and clinical routine care for the sample. Became 4 weeks after the end of the post-test intervention. To re-measure the three variables of the drug belief, self-efficacy and drug compliance in the two groups of intervention and control in the presence of a predetermined appointment with the researcher in the research environment is completed.
Settings and conduct
The present study is a randomized clinical trial. The aim of this study was to determine the effect of motivational interview on adolescents' beliefs about asthma, self-efficacy and drug compliance. The study population included adolescents with asthma who referred to the Asthma and Allergy Research Center of Tehran University of Medical Sciences.
Two-way blinding was done in participants and researchers. So, after the written consent of the participants and completion of the questionnaire, the envelopes made according to the randomized block are opened and the researcher and participant will be informed after the opening of the envelope that they are in the control group or in the intervention group.
After sampling and determining the group, each of the specimens is performed in the first pre-test session and scheduling intervention sessions for that sample if it is part of the intervention group. Patients in the intervention group will receive motivational interviews in four sessions of 40 to 60 minutes, individually per week based on the protocol described (for each motivational interview session). Session 1: Patient Assessment, Second Session: Interview with Patient in Connection with Environmental and External Barriers to Drug Abuse, Third Session: Interview with Patient in Connection with Individual and Internal Barriers to Drug Abuse, Session Four: Promoting Self-Efficacy Levels The client All interviews are conducted by a qualified person who has received the necessary training in this regard. The interviewer will use books, articles and CDs to improve his skill and experience in the field of motivational interviewing, but if the sample is in the control group, it will only run a pre-test and clinical routine care for the sample. Became 4 weeks after the end of the post-test intervention. To re-measure the three variables of the drug belief, self-efficacy and drug compliance in the two groups of intervention and control in the presence of a predetermined appointment with the researcher in the research environment is completed.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include: ages 12 to 18 years old, asthma diagnosis in the past year by the physician, the development of moderate and severe persistent asthma, daily use of asthma from corticosteroids by the patient, the lack of continuous use of the drug for problems other than illness Asthma is the ability to speak Persian and desire to communicate with scholars. Unwillingness to participate in the follow-up of the study, admission to the study period, incidents and unrelated stress-related experiences during the study, absence from the motivational interview in two consecutive sessions, attendance in other educational and counseling programs during the study Are also considered as exclusion criteria
Intervention groups
In the intervention group (69 people), 4 sessions of motivational interviewing take place each week. Then, the Drug Belief, Self-efficacy and Drug compliance questionnaire completed before the intervention was completed again by the participants one month after the last session of the Motivational Interview. Also, the participants in the control group (69) receive only the usual care for asthma patients and at the same time as the intervention group, the drug belief questionnaire completes the self-efficacy and drug compliance. The measure of effectiveness in the variables in the intervention group is to measure the score of the questionnaire.
Main outcome variables
Self-Efficacy, Beliefs Medicines and Medication Adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180217038766N1
Registration date:2018-03-04, 1396/12/13
Registration timing:prospective
Last update:2018-03-04, 1396/12/13
Update count:1
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Atefeh Barikani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 4422 1284
Email address
a-barikani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Motivational Interview on Self-Efficacy, Beliefs Medicines and Medication Adherence among Adolescents with Asthma
Public title
"Impact of Motivational Interview on Self-Efficacy", "Impact of Motivational Interview on Beliefs Medicines " "Impact of Motivational Interview on Medication Adherence"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for entering the study include: ages 10 to 14 years, asthma diagnosis in the past year by the physician, the occurrence of moderate and severe persistent asthma, daily use of asthma prevention by corticosteroids, non-use of the drug for problems other than illness Asthma is the ability to speak Persian and desire to communicate with scholars.
Exclusion criteria:
Unwillingness to participate in the study, hospitalization during the study period, incidents and unrelated stressful experiences during the study, absence from the motivational interview in two consecutive sessions, attendance in other educational and counseling programs during the study Are also considered as exclusion criteria.
Age
From 10 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
The research method is block random assignment in two groups of intervention and control. For this purpose blocks of size 4 will be used. To create a random sequence, the randomizer.org website will be used to hide the random allocation, and the numbered dark envelopes will be used, in which the group name will be specified in the random sequence generated. Then, according to the order of entering samples, the sample for the first sample of the envelope number one is opened and the group will be identified until the end.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bilingual blindness was conducted in participants and researchers in a way that the participants received the questionnaire after hearing the study objectives and the willingness of the company to study and sign the written consent, without the participants being aware that In the intervention group, or in the control group. The researcher also does not know that the participant is in the control group or the intervention, since after completing the questionnaire, the researcher opens the packet based on the random block and then realizes that the sample is in the control group or Intervention If the sample is in the control group, the researcher determines the post-test time for the sample and if the sample is in the intervention group, the researcher talks about setting the time for the intervention to be performed.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods. Keshavarz Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
3361648783
Approval date
2018-02-04, 1396/11/15
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4439
Health conditions studied
1
Description of health condition studied
Adolescents with Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Drug Compliance (MARS's 10-item questionnaire) was conducted to measure drug compliance, the grading rate was never = 5, rarely = 4, sometimes = 3, most often = 2, always = 1. The scores obtained from this The questionnaire is divided into 10, and thus the range of scores to be obtained in a questionnaire is from 1 to 5. A score of more than 4.5 indicates good drug compliance and a score of less than 4.5 indicates poor drug compliance.)
Timepoint
Before intervention and 1 month after the last intervention session
Method of measurement
questionnaire Medication Adherence (MARS)
2
Description
Belief in the questionnaire was a questionnaire consisting of two dimensions of the necessity of drug use and concerns about drug issues. The method of scoring based on Likert scale was totally opposite = 1, opposed = 2 , No matter = 3 I agree = 4 I totally agree = 5. Out of the 11 items, the BMQ 5 questionnaire is followed by concerns about drug issues and 6 afterwards on the need for drug use. The next scores for drug issues concern The sum of these is divided into 5, and the 6th grade points of the next need for drug use are combined and divided into six. The scores that can be obtained from the two dimensions mentioned above can be summarized. Dentistry varies between 1 and 5. Higher score = 5 in the dimension of concerns Concerns about drug issues The BMQ questionnaire indicates more concern about long-term use of the drug and a lower score of 1 indicates a lower concern regarding the long-term use of Medication. But in the case of the need for drug use, a higher score of 5 indicates a greater belief in the necessity of taking the drug for health and a lower score of 1 indicates a lower belief in the necessity of taking the drug to provide health.
Timepoint
Before intervention and 1 month after the last intervention session
Method of measurement
questionnaire Beliefs Medicines (BMQ)
3
Description
Self-efficacy (CASES 14-item questionnaire for measuring self-efficacy in adolescents), this questionnaire consists of two dimensions of prevention of asthmatic attacks (Gove1-8) and management of asthmatic attacks (Clause 9-14). The scoring method is not at all safe. = 1, I'm pretty sure = 2, I'm fairly sure = 3, I'm pretty sure = 4, I'm pretty sure = 5. Of the 14 items in the CASES 8 questionnaire, the item is dedicated to preventing asthma attacks and 6 items for management of asthma attacks. The scoring criteria available in the prevention of asthma attacks range from 40-40% and in the management of asthmatic attacks is 6-30. A score of more than 40 in the prevention of asthma attacks indicates better prevention than H Asthma mortality and score less than 8 indicate a weakness in the prevention of asthma attacks and a greater score of 30 in the management of asthma attacks suggests better management of asthmatic attacks and a score of less than 6 indicates a weakness in the management of asthma attacks.)
Timepoint
Before intervention and 1 month after the last intervention session
Method of measurement
questionnaire Self-efficacy of childhood with asthma (CASES)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: There is only one intervention group. In the intervention group, motivational interviewing takes place in four sessions of 40 to 60 minutes, individually per week based on the protocol described (for each motivational interview session). Session 1: Patient Assessment, Second Session: Interview with Patient in Connection with Environmental and External Barriers to Drug Abuse, Third Session: Interview with Patient in Connection with Individual and Internal Barriers to Drug Abuse, Session Four: Promoting Self-Efficacy Levels The client
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Respiratory Clinic of Children's Medical Center in Imam Khomeini Hospital
Full name of responsible person
Atefeh Barikani
Street address
Imam Khomeini Children's Medical Center, Keshavarz Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
3361648783
Phone
+98 26 4422 1284
Email
barikani2000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of Tehran University of Medical Sciences
Street address
Ghods Ave, Keshavarz Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
3361648783
Phone
+98 26 4422 1284
Email
barikani2000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
atefeh barikani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran East Nusrat Street. School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3361648783
Phone
+98 26 4422 1284
Email
barikani2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
reza negarandeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran East Nusrat Street.Schoole of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3361648783
Phone
+98 21 6105 4581
Email
negarandeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
atefeh barikani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran. East Nusrat Street. School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3361648783
Phone
+98 26 4422 1284
Email
barikani2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
"Starting the access period 12 months after printing results"
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Only the results of the study are to be used and, except for this case, there is no right in the analysis or other matters.
From where data/document is obtainable
atefeh barikani .by email barikani2000@gmail.com
What processes are involved for a request to access data/document
Whoever wants the study information should contact Atefeh Barikani by email. And if he accepts the terms from his / her side, the respondent will be informed as soon as possible.