general purpose
1) Designing, implementing and evaluating the care program for adherence to treatment in patients with asthma who refer to the asthma clinic of hospitals affiliated to Shahid Beheshti University of Medical Sciences 1401
Design
The research population is the patients with asthma, which is done by the available sampling method and is divided into two intervention and control groups by random allocation method.
Settings and conduct
In this study, which will be conducted on patients with asthma in hospitals affiliated to Shahid Beheshti University of Medical Sciences, the level of adherence to treatment will be checked with a questionnaire whose validity and reliability have already been checked, and the needs of the patients will be extracted through it. And then based on that a care plan is prepared and based on that care plan is taught to the patients in 3 to 5 sessions and after two months the questionnaire is done again by the intervention and control group and the level of treatment compliance in these two groups is compared
Participants/Inclusion and exclusion criteria
Criteria for entering
• Has asthma and at least 3 months have passed since the diagnosis
• Frequent recurrence of the disease
• Having a minimum education level of a diploma
• Age 18 to 60 years
Exclusion criteria
• Incomplete completion of the questionnaire
• Failure to accept the care plan
• Foot
Intervention groups
The samples are 94 people, who are divided into two intervention and control groups, and for the intervention group, a care plan is implemented, and for the control group, they receive routine clinic treatments and are evaluated after 2 months.
Main outcome variables
Adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220815055708N1
Registration date:2022-09-21, 1401/06/30
Registration timing:registered_while_recruiting
Last update:2022-09-21, 1401/06/30
Update count:0
Registration date
2022-09-21, 1401/06/30
Registrant information
Name
Faranak Ghorbanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3653 7472
Email address
faranakghorbanian76@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, Implementation and Evaluation of Care Program Adherence to Treatment in Patients with Asthma
Public title
Design, Implementation and Evaluation of Care Program Adherence to Treatment in Patients with Asthma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
• Has asthma and at least 3 months have passed since the diagnosis
• Frequent recurrence of the disease
Having a minimum education level of diploma
Age 18 to 60 years
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples will be entered into the study using the available sampling method and based on the entry criteria, and in this study, random allocation will be done, for this purpose, the researcher will first determine a total sample size, and then randomly (by lottery method) ) will assign groups of them to the intervention group and assign the rest to the control group.
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 Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
Tehran, intersection of Valiasr and Ayatollah Rafsanjani, Beheshti Nursing and Midwifery Faculty
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-08-09, 1401/05/18
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.099
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of treatment adherence program on adherence to treatment regimen
Timepoint
After the implementation of the care program, 2 months later, the effectiveness of this care program will be checked
Method of measurement
by questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Asthma patients who receive care plan
Category
Other
2
Description
Control group: Asthma patients who do not receive a care plan
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Affiliated Hospitals of Shahid Beheshti University of Medical Sciences and Health Services - Faculty
Full name of responsible person
forozan atashzade
Street address
Intersection of Valiasr and Ayatollah Rafsanjani Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Forozan atash zade
Street address
Intersection of Valiasr and Ayatollah Rafsanjani Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
School of Nursing and Midwifery
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Ghorbanian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, the intersection of Valiasr and Ayatollah Rafsanjani, in front of Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 26 3653 7472
Fax
Email
Faranakghorbanian76@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Ghorbanian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, the intersection of Valiasr and Ayatollah Rafsanjani, in front of Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 26 3653 7472
Fax
Email
Faranakghorbanian76@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Ghorbanian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, the intersection of Valiasr and Ayatollah Rafsanjani, in front of Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 26 3653 7472
Fax
Email
Faranakghorbanian76@yahoo.com
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