Protocol summary

Study aim
Determining the Impact of Pender's health promotion model on adherence to treatment and Blood pressure in patients with hypertension in Shahid Beheshti health center in Kashan, 1396
Design
In this research, 80 Hypertensive patients referring to Shahid Beheshti health center in Kashan were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
After approval of the research project by the Research Council of the University of Medical Sciences and obtaining permission from the Ethics committee of the University of Medical Sciences, and coordination with the officials of the Shahid Beheshti Hospital, the researcher referred to Shahid Beheshti Medical Center Clinic during the week, morning and evening and with the help of the Center staff, after expressing the research goals and ensuring patients are kept confidential and obtain informed written consent from them, select patients who have been admitted to the study and after sampling, patients are assigned randomly between intervention and control groups. The content of perceptual intervention in blood pressure control from valid sources based on the constructs of the Pender Health Promotion Model and validated by 10 nursing and cardiologists. in the intervention group, educational intervention in accordance with Pender model with routine care during 6 sessions of 45-60 minutes for 6 weeks in small groups of 4 to 6 people with group discussion and question and answer in Shahid Beheshti Medical Center will be done. Meanwhile, both groups receive routine training from the center, which includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran. Measurement of adherence to treatment in the first session (at the time of admission), the sixth session (the end of training) and one month and two months after the end of education is performed by the questionnaire of treatment of peasant and colleagues. Meanwhile, control of patients' blood pressure during the first session (on arrival), the third session (during training), the sixth session (the end of training) and one month and two months after the end of training together with the full compliance of the 7th JNC Guideline with the German manufacture of Bosch mercury device Germany. Educational intervention and distribution and completion of questionnaires by researcher-designer who was a master student of Surgical Internal Nursing and receives the necessary training in the field of the project, according to the previous planning.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Being a citizen of Iranian and Persian languages 2. The ability to communicate verbally 3. Age 20 to 65 years old 4. Having a primary hypertension with cardiologist confirmed 5. At least 6 months have passed since the diagnosis of the disease 6. Patients who score questionnaire based on their adherence to treatment adherence is less than 86. 7. The lack of physical and mental debilitating diseases known for example, MR, depression and cancer 8. Location in Kashan 9. Along the patient is literate 10. The desire and informed consent to participate in the study Exclusion criteria: 2. Unwillingness to continue cooperation during the study 2. The absence of training sessions (more than one session) 3. Changes in the course of illness and patient's therapies so that the type of drug or dose of his medication changes. 4. Having a disease or complication that leads to hospitalization during the study, such as heart attacks, stroke, kidney failure, etc.
Intervention groups
Patients are invited to participate in the study and as knowledge and purpose of the study are aware, after obtaining informed consent in the intervention and control groups sorted but they are not aware of this classification in the control or intervention group. 1- Intervention group: (Education Based on Pender Health Promotion Model) The content of perceived cessation of blood pressure control from valid sources is based on the Pender Health Promotion Model constructs and Validated by 10 nursing and cardiologists. In this group, educational intervention according to Pender model with routine care during 6 sessions of 45-60 minutes for 6 weeks in groups of 4 to 6 people with group discussion and question and answer in Shahid Beheshti Medical Center will be done.The center's routine training also includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran. 2- Control group: (Routine training in medical center) The routine training of the center includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran.
Main outcome variables
Systolic blood pressure Diastolic blood pressure Median Arterial Pressure (MAP) Kind of treatment of hypertension score of Adherence to treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100829004655N7
Registration date: 2018-01-22, 1396/11/02
Registration timing: registered_while_recruiting

Last update: 2018-01-22, 1396/11/02
Update count: 0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of use health promotion Pender's Model on Adherence to Treatment and Blood Pressure in Patients with Hypertension
Public title
Effect of use health promotion Pender's Model on Adherence to Treatment and Blood Pressure in Patients with Hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being a citizen of Iranian and Persian languages The ability to communicate verbally Age 20 to 65 years old Having a primary hypertension with cardiologist confirmed At least 6 months have passed since the diagnosis of the disease Patients who score questionnaire based on their adherence to treatment adherence is less than 86. The lack of physical and mental debilitating diseases known for example, MR, depression and cancer Location in Kashan Along the patient is literate The desire and informed consent to participate in the study
Exclusion criteria:
Unwillingness to continue cooperation during the study The absence of training sessions (more than one session) Changes in the course of illness and patient's therapies so that the type of drug or dose of his medication changes. Having a disease or complication that leads to hospitalization during the study, such as heart attacks, stroke, kidney failure, etc.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is continuous and patients are divided into 4 randomized blocks between intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are invited to participate in the study and as knowledge and purpose of the study are aware, after obtaining informed consent in the intervention and control groups sorted but they are not aware of this classification in the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Individuals in the intervention and control groups, randomly allocated blocks (blocks 4-procurement and selection will be based on them)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.25

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Adherence to Treatment
Timepoint
Baseline, 1 and 2 months after completion of intervention
Method of measurement
treatment adherence questionnaire for patients with hypertension (TAQPH) Persian version

2

Description
blood pressure
Timepoint
Baseline, weeks 1, 3, 5 and 1and 2 month after the intervention
Method of measurement
In compliance with all standards of JNC 7 using a mercury manometer adults model F.BOSCH (GERMANY), which was calibrated with mercury healthy.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Education Based on Pender Health Promotion Model. The content of perceived cessation of blood pressure control from valid sources is based on the Pender Health Promotion Model constructs and Validated by 10 nursing and cardiologists. In this group, educational intervention according to Pender model with routine care during 6 sessions of 45-60 minutes for 6 weeks in groups of 4 to 6 people with group discussion and question and answer in Shahid Beheshti Medical Center will be done.The center's routine training also includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran.
Category
Behavior

2

Description
Control group: Routine training in medical center. The routine training of the center includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center of Kashan University of Medical Sciences
Full name of responsible person
Taghadsi Mohsen
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Email
hossein1396@chmail.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Arctic Blvd Ravandi, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravandi Ghotb Blvd
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
+98 31 5546 6333
Email
taghadosi_m@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravandi Ghotb Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 31 5546 6333
Email
taghadosi_m@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hossein Nouri Perkhestani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravandi Ghotb Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 31 5546 6333
Email
hossein1397@chmail.ir

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academia and academia.
Under which criteria data/document could be used
If you observe the trust and mention the source, data is available for researchers.
From where data/document is obtainable
Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
What processes are involved for a request to access data/document
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.
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