Effect of Combined Self-Care Training on Adherence to Therapy in Patients Afflicted with High Blood Pressure Admitted to Shahin Dezh Hospital, in 2016
Design
A clinical trial with a sample size of 60 people with a control group, randomized with lottery method
Settings and conduct
The study was conducted in a clinic of Shahin Dezh Hospital in an educational intervention for test group for the duration of 4 weeks
Participants/Inclusion and exclusion criteria
Not having a high blood pressure above 110/180, or any evidence of an emergency, stroke or myocardial infarction in the past six months;Complications of illness and hospitalization
Intervention groups
Patients with high blood pressure were evaluated in both control and intervention groups. Educational intervention was conducted for the intervention group for 4 weeks. The control group received routine training. The data gathering tool was a follow-up questionnaire that was completed for both groups before and after intervention.
Main outcome variables
Adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160220026662N2
Registration date:2018-09-03, 1397/06/12
Registration timing:retrospective
Last update:2018-09-03, 1397/06/12
Update count:0
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Nader Aghakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4816
Email address
nader1453@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-20, 1396/02/30
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care blended education on treatment adherence in hypertensive patients
Public title
The effect of blended education on treatment adherence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least the reading and writing skills
Absence of a sick person or a close relative of his relatives in the healthcare team
Not having malignant disease or mental illness according to file information
Having aged 20 to 65 years old
Having a blood pressure higher than 90/140 and less than 110/180
Being treated for at least six consecutive months without diabetes or chronic kidney disease
Not having a high blood pressure above 110/180, or any evidence of an emergency, stroke or myocardial infarction in the past six months
Lack of unstable angina, grade 3 or 4 heart failure, serious liver or kidney disease, and pregnancy
Exclusion criteria:
Cancellation of the continuation of the study for any reason (lack of cooperation or death)
Lack of access by phone and telephone with the patient and his family while conducting research
Complications of illness and hospitalization
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized randomization by lottery method
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
Ethics committee of Urmia University of medical Sciences
Street address
Orjhans Ave, Resalat Blvd
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
Ir.Umsu.rec.1396.30
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Treatment adherence
Timepoint
Measure the grade of adherence to the treatment before the intervention and 2 weeks after the intervention
Method of measurement
Adherence to treatment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational intervention is based on the implementation of combined education including educational videos, pamphlets, lectures, and group discussions
Category
Prevention
2
Description
Control group: Provide routine training
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Shahin Dezh Hospital
Full name of responsible person
Zahra Rahimi
Street address
Dastgheib
City
Shahindezh
Province
West Azarbaijan
Postal code
59731-34757
Phone
+98 44 4632 3190
Email
tara94026@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Uremia University of Medical Sciences
Full name of responsible person
Rahim Begaye
Street address
Pardis Nazlou, 11 km of Nazlou Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Fax
+98 44 3224 0642
Email
rbaghaei2001@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Uremia 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
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Rahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahmadabad Village
City
Shahindezh
Province
West Azarbaijan
Postal code
5973134757
Phone
+98 44 4644 6392
Email
tara94026@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
11 km to the road of Serve, Nazlou, Faculty of Nursing & Midwifery, Uremia
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3275 4963
Email
naderaghakhani2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Rahimi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahmadabad Village
City
Shahindezh
Province
West Azarbaijan
Postal code
5973134757
Phone
+98 44 4644 6392
Email
tara94026@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