Determining the effect of teaching self-care behaviors based on the behavior change model (5A) on health self-care behaviors to control blood pressure in the elderly
Design
Clinical trial, with simple randomization, without blinding, on 90 patients
Settings and conduct
This clinical trial study will be conducted on 90 elderly people over 60 years of age with high blood pressure who referred to the Babol University of Medical Sciences hospital clinic in 1402. The elderly will be randomly divided into two test groups (45 people) and control (45 people). Model 5A self-management program includes group training and individual guidance. The elderly will be followed up by phone calls within 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 60 years old, Suffering from high blood pressure diagnosed by a doctor, With the possibility of access and follow-up by phone
Exclusion criteria: Absence of malignant diseases, insufficiency and neurological diseases based on the medical history entered in the medical record.
Intervention groups
Referees are divided into two groups of 45 people, test and control. The control group will receive common treatments or the use of common drugs. In addition to common treatments, the test group will also receive training on self-care behaviors based on the 5A model. The self-management program will be implemented for each patient in the test group in 5 stages during 12 weeks.
Main outcome variables
Behavioral change leading to blood pressure control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230812059127N1
Registration date:2023-11-01, 1402/08/10
Registration timing:retrospective
Last update:2023-11-01, 1402/08/10
Update count:0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
Seyedeh Sadaf Bozorgnia Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3536 4129
Email address
s.bozorgnia.h@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care behavior training based on the 5A model on health self-care behaviors to control blood pressure in the elderly
Public title
Investigating the effect of self-care training on behavior change in blood pressure control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Diagnosis of hypertension for at least one year based on medical records
Having hypertension diagnosed by a doctor
Speak in persian
With the possibility of access and follow-up by phone
Exclusion criteria:
Suffering from malignant diseases based on the medical history entered in the medical record
Suffering from heart failure based on the medical history entered in the medical record
Suffering from kidney failure based on the medical history recorded in the medical record
Suffering from hyperthyroidism based on the medical history recorded in the medical record
Suffering from depression and neurological diseases based on the medical history entered in the medical record
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
90 people who have been diagnosed with high blood pressure by a doctor and who meet the criteria for entering the study are selected easily from among those who refer to the hospital clinic of Babol University of Medical Sciences. After that, they will be randomly divided into 2 intervention and control groups. For this purpose, the cards with the test and control written on them are put in a box and each of the samples is asked to choose a card randomly, after that people with test cards in the test group and people who have a control card, are placed in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnourd
City
Bojnourd
Province
North Khorasan
Postal code
9414974877
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.NKUMS.REC.1402.065
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
Behavior change
Timepoint
The Hypertension-Self-care Activity Level Effects questionnaire will be completed once at the beginning of the research and again after 12 weeks for both groups (test and control).
The systolic and diastolic blood pressure of the client is measured and recorded by the research assistant in two stages, the first week and the twelfth week respectively.
Method of measurement
Mercury sphygmomanometer
Intervention groups
1
Description
Control group: Referees are divided into two groups of 45 people, test and control. The first group will receive common treatments or the use of common drugs.
Category
Behavior
2
Description
Intervention group: In addition to common treatments, the second group will also receive training on self-care behaviors based on the A5 model.The self-management program will be implemented for each patient in the test group in 5 stages during 12 weeks. In the first week of the research, the first, second and third stages will be implemented in the following order:First step: Examining the awareness, behaviors and beliefs of the patientStep 2: Counseling the patient about the health risks and benefits of behavior changeThe third step: agreement with the patient in the field of setting realistic goals(The first three stages will be done during a 2-hour session in one day)Step 4: Helping to develop a practical plan (with a family member)A 2-hour group training session will be held one week after individual guidance to increase the patient's awareness of their disease.Fifth step: follow upThen the performance of the patients will be followed for 12 weeks. In order to ensure the implementation of the practical plans by the patients in the first 2 weeks, phone calls will be made three times a week and after that weekly phone calls will be made with the patients to remind them to complete the practical plans. In addition, the progress of the patient will be followed up once every 4 weeks during a face-to-face meeting. In this meeting, the agreed program and the patient's self-report book will be reviewed so that essential changes can be made if needed.After the end of 12 weeks, the aforementioned questionnaires will be provided to the patients of both groups and they will be examined in terms of the studied variables.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Clinic of Babol University of Medical Sciences
Full name of responsible person
Seyedeh Sadaf Bozorgnia Hosseini
Street address
Sharifi Blvd. 13 Sharifi
City
Babolsar
Province
Mazandaran
Postal code
4741745494
Phone
+98 11 3536 4129
Fax
Email
s.bozorgnia.h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Bahram Bibak
Street address
Dolat Blvd
City
Bojnoord
Province
North Khorasan
Postal code
9414974877
Phone
+98 58 3151 0000
Email
INFO@NKUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Seyedeh Sadaf Bozorgnia Hosseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sharifi Blvd. 13 Sharifi
City
Babolsar
Province
Mazandaran
Postal code
4741745494
Phone
+98 11 3536 4129
Email
s.bozorgnia.h@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyedeh Sadaf Bozorgnia Hosseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sharifi Blvd. 13 Sharifi
City
Babolsar
Province
Mazandaran
Postal code
4741745494
Phone
+98 11 3536 4129
Email
s.bozorgnia.h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyedeh Sadaf Bozorgnia Hosseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sharifi Blvd. 13 Sharifi
City
Babolsar
Province
Mazandaran
Postal code
4741745494
Phone
+98 11 3536 4129
Email
s.bozorgnia.h@gmail.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