Investigating the effect of education based on Roy's adaptation model on adherence to the treatment and medication regimen of patients with hypertension in comprehensive health centers affiliated of Shahid Beheshti University of Medical Sciences in Tehran in 2022
Determination the effect of education based on Roy's adaptation model on adherence to the treatment and medication regimen of patients with hypertension in comprehensive health centers affiliated of Shahid Beheshti University of Medical Sciences in Tehran in 2022
Design
Clinical trial with 2 randomized parallel groups on 134 patients
Settings and conduct
comprehensive health care centers of Shahid Beheshti University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with hypertension; administration of antihypertensive medications. Exclusion criteria: Unwillingness to participate in the study; patients who can't be educated due to psychological disorders.
Intervention groups
In intervention group, participants will be educated based on Roy's Adaptation Model.
Participants in control group will be educated based on the routine of the health center.
Main outcome variables
Adherence to medication regimen, adherence to treatment plan, Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220502054719N1
Registration date:2022-05-27, 1401/03/06
Registration timing:registered_while_recruiting
Last update:2022-05-27, 1401/03/06
Update count:0
Registration date
2022-05-27, 1401/03/06
Registrant information
Name
Amirmohamad Amidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 1678
Email address
amirmohamad.amidi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-15, 1401/02/25
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education based on Roy's adaptation model on adherence to the treatment and medication regimen of patients with hypertension in comprehensive health centers affiliated of Shahid Beheshti University of Medical Sciences in Tehran in 2022
Public title
Investigating the effect of RAM on adherence to treatment and medication regimen of hypertensive people
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed as a hypertensive patient by a physician
Taking anti-hypertension medications
Being able to read and write
Covered by a comprehensive health center
Minimum age 18 years old and maximum age 60 years old
Exclusion criteria:
Unwillingness to participate in the study
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:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster randomized method will be used in this clinical trial. At first a list of health care centers affiliated to Shahid Beheshti University of Medical Sciences will be attained(North, Shemiranat and East). Then a zone will be chosen randomly and 2 health care centers will be chosen by draw randomly as clusters. Name of health centers will be put into same balls and they will be put into a pot, after mixing the balls one ball will be chosen randomly and first ball chosen will be the health center considered as the luster which interventions group will be chosen from there. The second ball chosen will be the health center considered as the cluster which control group will be chosen there. Then participants will be chosen from each cluster by random table number. It mean intervention group and control group are chosen before using random number table. So random number table will not determine which patient will be in intervention group or control group because intervention group and control group has been chosen by draw before. One health center is the intervention group and the other one is the control group by draw as explained. Therefore it is clear that each health center is chosen as a cluster and it is clear that which cluster contains intervention group and the other cluster contains control group. Then among all patients available for intervention or control group 67 patients will be chosen for each group by random number table. In the end in each of intervention and control groups a number will be given to all patients available then the numbers will be organized in columns or rows and researcher will choose randomly the starting point by eyes closed and a pen and first numbers chosen by eyes closed will be considered as chosen samples. By choosing each number the next number will be chosen among bigger numbers. Then choosing numbers randomly will be continued by eyes closed until 67 patients be chosen for each 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
Iran national committee for ethics in biomedical research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
ندارد
Approval date
2022-04-26, 1401/02/06
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.031
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I15.9
ICD-10 code description
Secondary hypertension, unspecified
Primary outcomes
1
Description
Adherence to treatment plan
Timepoint
Before intervention and after intervention
Method of measurement
Hill-Bone High Blood Pressure Compliance Scale
2
Description
adherence to medication regimen
Timepoint
Before intervention and after intervention
Method of measurement
Morisky Medication Adherence Scale (mmas-8)
3
Description
Blood Pressure
Timepoint
Before intervention and after intervention
Method of measurement
Sphygmomanometer available in the health care center.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People with hypertension are randomly divided into 4 groups, each group includes 8 or 9 patients. Each session lasts 45-60 minutes. In each session patients will be educated about one mode of Roy's adaptation model. Based on data collected from Pre-test session patients will be educated about each mode pf Roy's model in separate sessions. In session 2 patients will be educated about physiologic mode like: education about the effect of medications in controlling hypertensive situations. Education about when can they stop taking their medications and about exercising and its effects and also what can happen if they spontaneously stop taking their medications. In session 3 Patients will be educated about self-concept mode: The effect of managing stress and anxiety in preventing of hypertensive situations, talking about stressful factors to intimate people and friends to lessen anxiety, talking about stress managing skills. In session 4 patients will be educated about role function mode: Educating about the importance of being among family and in society and taking advise from successful people in controlling hypertension. Educating about controlling blood pressure twice a week and taking to their physician each 3 week about status of hypertension and medications they take. In session 5 patients will be educated about interdependence mode: Educating about talking about stressful factors to family members to reduce stressful moments, importance of gaining support from family and the effect of family members and friends in improving adherence to treatment plan and medication regimen. And educating about how religious beliefs parallel to care plan can improve the adherence to treatment and medications. At the end of sessions a needs assessment form will be given to participants to see if they need more education or not.
Category
Lifestyle
2
Description
Control group: People with hypertension. In this group, clients will be educated about hypertension same as the routine of that health center.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Not chosen yet
Full name of responsible person
Not chosen yet
Street address
Not chosen yet
City
Tehran
Province
Tehran
Postal code
تا زمان اخذ مجوز نمو
Phone
+98 21 2248 7057
Email
amirmohamad.amidi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Chamran blvd, yemen st. building 2
City
Tehran
Province
Tehran
Postal code
مشخص نیست
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Thesis Budget
Proportion provided by this source
70
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
Amirmohamad Amidi
Position
Master of Public Health Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
نامشخص
Phone
+98 21 8865 5382
Email
amirmohamad.amidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Meimanat Hosseini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
نامشخص
Phone
+98 21 8865 5382
Email
meimanathosseini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirmohamad Amidi
Position
Master of Public Health Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
نامشخص
Phone
+98 21 8865 5382
Email
amirmohamad.amidi@gmail.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