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The effect of self-care education program on the Adherence to treatment of elderly with hypertension

Protocol summary

Study aim
The effect of self-care education on adherence for hypertensive elderly
Design
parallel clinical trial with two groups
Settings and conduct
Research Environment: The Heart Clinic Sayyad Shirazi Gorgan in Golestan University of Medical Sciences.The research sample included a sample of elderly patients with hypertension referring to the heart clinic of Sayyid Shirazi, Gorgan, during the research period, which will have criteria for entry into the study, by the available sampling method, initially entered into the study. Among those who are subjected to moderate, poor follow-up treatment (subtracting the score from the treatment sub scale of less than 49%), They will be randomly assigned to the intervention and control groups.. In the intervention group, the self-care educational program is provided in group and received routine care in the control group. Before, immediately and two months later, the adherence questionnaire will be completed. And at this time, the patient's blood pressure will also be recorded
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 60 years, the ability to read and write, consent, having no known disease and mental disorders, Having hypertension and specialist endorsement. Exit criteria: Absence of more than one session in the classroom, death, travel and relocation of the participant during the study, the patient's unwillingness to continue.
Intervention groups
intervention group: In addition to the usual care, the self-care training program (4consecutive sessions per week for each group, 45 people are divided into five groups of nine,duration of each session is one And for half an hour, the time of the class will be presented at the morning, Immediately and 2 months after education each of the test groups will complete the questioner.
Main outcome variables
Adherence to treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180505039536N1
Registration date: 2018-10-27, 1397/08/05
Registration timing: registered_while_recruiting

Last update: 2018-10-27, 1397/08/05
Update count: 0
Registration date
2018-10-27, 1397/08/05
Registrant information
Name
Zahra Sabzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3243 0310
Email address
dr.sabzi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education program on the Adherence to treatment of elderly with hypertension
Public title
The effect of self-care education program on the Adherence to treatment of elderly with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Compliance score of moderate and lesser treatment based on Mandealou's treatment compliance questionnaire
Exclusion criteria:
elderly with hypertension
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will randomly assigned to control and intervention groups based on the permutation blocks method.Six possible modes ( AABB, ABAB,..) are listed and randomly determine the number of blocks required and the subjects will be placed on the test group (B) and control (A) respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome evaluator Data analysis is done by Anonymous to research
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethices Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Golestan, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
49165-568
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.GOUMS.REC.1397.109

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
I11
ICD-10 code description
Hypertensive heart disease

Primary outcomes

1

Description
adherence to treatment
Timepoint
Before, immediately and 2 months later
Method of measurement
Questionnaire scores of adherence to treatment

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Elderly people with hypertension have criteria to enter the studyIn addition to routine care, an intervention will be performed on self-care program for hypertension for two weeks (two sessions per week and group) and "each group of 10" and each session will be given an hour. The training program will also be provided in writing to Pamphlet
Category
Behavior

2

Description
Control group: Elderly patients with hypertension who have been include criteria and receive routine care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayad Shirazi Hospital, Golestan University of Medical Sciences, Gorgan, Iran
Full name of responsible person
Zahra Sabzi
Street address
Golestan University of Medical Sciences, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
49165-568
Phone
+98 17 3245 6900
Email
zsgorgan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Deputy of Research and Technology. Golestan University of Medical Sciences, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
49165-568
Phone
+98 17 3245 6900
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=12
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Zahra Sabzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan University of Medical Sciences, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
49165-568
Phone
+98 17 3245 6900
Email
dr.sabzi@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zahra Sabzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
49165-568
Phone
+98 17 3245 6900
Fax
+98 17 3245 1657
Email
dr.sabzi@goums.ac.ir
Web page address
http://goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zahra Sabzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
49165-568
Phone
+98 17 3245 6900
Email
zsgorgan@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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
All data will be shared after unidentifiable people.
When the data will become available and for how long
Data will be available for scholars working in academic and academic institutions.
To whom data/document is available
Meta-analysis is allowed on data
Under which criteria data/document could be used
Please contact the person responsible for the scientific data
From where data/document is obtainable
Access to data through email and after obtaining permission from researchers is possible
What processes are involved for a request to access data/document
For more information, please, check e-mail. dr.sabzi@goums.ac.ir
Comments
Email the following email address zsgorgan@yahoo.com dr.sabzi@goums.ac.ir
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