The effect self- care program of family-oriented on compliance with the drug regimen and diet in Patients with hypertension
Design
Two arm parallel group randomised trial with postoperative care and outcome assessment
Settings and conduct
In the intervention group: Using two training sessions in the training sessions,in the hospital, the training will be given to improve the compliance of the diet and dietary regimen and will help the patient and his or her family with three sessions of home visits to correct lifestyle . Then the patient is evaluated
In the control group: the questionnaires are filled in at home
Participants/Inclusion and exclusion criteria
Inclusion criteria : Diagnosis of hypertension by the doctor
Failure to receive home visits in the past
Have a reading and writing literacy
Exclusion criteria:
Dialysis
being admitted to the hospital
No family or friend
Intervention groups
In the intervention group, after filling out the dietary questionnaires and following Medication Adherence Scale -8 and regimen Scale, two group training sessions will be provided with family support for self-care home-based self-care programs for observing the diet and the diet to patients and families, followed by three home visits and Questionnaires are filled in immediately and two months later and statistics are evaluated.
In the control group, Medication Adherence Scale -8 and regimen Scale was filled in three stages of the diet and follow-up, and a group training session was given to patients after evaluation of the statistics.
Main outcome variables
Adherence to drug use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180116038389N1
Registration date:2018-12-26, 1397/10/05
Registration timing:retrospective
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Zahra Givpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 9350
Email address
z.givpoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
2019-11-21, 1398/08/30
Scientific title
The effect of self- care program of family-oriented on compliance with the drug regimen and diet in Patients with hypertension
Public title
The effect self- care program of family-oriented on compliance with the drug regimen and diet in Patients with hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of hypertension by the doctor
Failure to receive home visits in the past
Not having mental illness and addiction
Have a reading and writing literacy
Exclusion criteria:
Hospitalization of the patient
Patient dialysis
Age
From 45 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method using table numbers
The pair numbers of the intervention group and the individual numbers of 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
Ethics committee of Isfahan University of Medical Sciences
Street address
No 17, Bahar Alley,Roodaki Ave
City
Isfahan
Province
Isfehan
Postal code
8176946411
Approval date
2017-11-19, 1396/08/28
Ethics committee reference number
396874 IR.MUI.REC.1396.3.874
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I15
ICD-10 code description
Secondary hypertension
Primary outcomes
1
Description
compliance with the drug regimen and diet
Timepoint
Before intervention, Immediately later intervention, 2months later intervention
Method of measurement
Morisky Medication Adherence Scale
Secondary outcomes
1
Description
Better Adherence to Diet and Medicines and Reduce Blood Pressure
Timepoint
For both intervention and control groups :Before intervention, immediately after intervention and two months later intervention
Method of measurement
Morissky Medication Adherence Scale8
2
Description
Decreased blood pressure
Timepoint
For both intervention and control groups :Before intervention, immediately after intervention and two months later intervention
Method of measurement
with Blood Pressure
Intervention groups
1
Description
Intervention group: In the intervention group, two groups of group training are taught in 6 groups of patients with the family. Then, using the home visit method, the problems with the use of medications and diet are identified and they are resolved according to the facilities of the family. And leads to better diet and drug compliance and promotes community health and reduces health care costs
Category
Lifestyle
2
Description
Control group: the questionnaires are filled in before the intervals, before, and two months later, and after the evaluation of a session, they are taught.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isa ebn maryam hospital
Full name of responsible person
Zahra Givpour
Street address
Shams abadi Ave,
City
Isfahan
Province
Isfehan
Postal code
8176846411
Phone
+98 31 3233 9014
Fax
+98 31 3236 1944
Email
z.givpoor@yahoo.com
2
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Zahra Givpour
Street address
Modares Ave
City
Isfahan
Province
Isfehan
Postal code
8176946411
Phone
+98 31 3445 2032
Fax
Email
z.givpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Habib Hoseini
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7602
Fax
+98 31 3669 9398
Email
webmaster@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Habib Hoseini
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746733461
Phone
+98 31 3792 7602
Email
h_hoseini@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Habib Hoseini
Position
Associate professo
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7602
Email
h_hoseini@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Habib Hoseini
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746733461
Phone
+98 31 3792 7602
Email
h_hoseini@nm.mui.ac.ir
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