Protocol summary
-
Study aim
-
Determining the effect of education based on the Common-Sense Model of Self-Regulation on illness perception among elderly patients with hypertension: A Randomized Controlled Clinical Trial
-
Design
-
A clinical trial with a control group, with parallel groups, double-blind, randomized on 62 patients with hypertension in the elderly with a one-month follow-up.
-
Settings and conduct
-
The present study will be conducted on elderly people with primary hypertension referring to health centers affiliated to Larestan University of Medical Sciences
-
Participants/Inclusion and exclusion criteria
-
suffering from complications due to blood pressure and absence more than once in training sessions
Unwillingness to participate in the study
Participation in similar educational and research projects during the course of study
-
Intervention groups
-
Receive 5 training sessions based on common sense self-regulation model.
The researcher interacted with the patients and explained the objectives of the study and assessed the patient's understanding of the nature, causes, symptoms and management of hypertension. A researcher asked the patient the following questions: What is high blood pressure? What is its normal range? What are the causes of high blood pressure? Which causes are controllable and which are uncontrollable? What do you do to manage and control your blood pressure?
-
Main outcome variables
-
The score of Broadbent's illness perception
General information
-
Reason for update
-
Changes in inclusion criteria to reach the required sample size
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20240122060771N2
Registration date:
2024-03-24, 1403/01/05
Registration timing:
registered_while_recruiting
Last update:
2025-01-05, 1403/10/16
Update count:
1
-
Registration date
-
2024-03-24, 1403/01/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2024-02-19, 1402/11/30
-
Expected recruitment end date
-
2024-04-20, 1403/02/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effect of education based on the Common-Sense Model of Self-Regulation on illness perception among elderly patients with hypertension: A Randomized Controlled Clinical Trial
-
Public title
-
Effect of education based on the Model of Self-Regulation on illness perception among elderly patients with hypertension
-
Purpose
-
Education/Guidance
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients must be 60 years old or older.
a confirmed diagnosis of primary hypertension classified as either stage 1 or stage 2
A minimum duration of hypertension of six months
Provision of informed consent to participate.
Exclusion criteria:
patients' refusal to participate
Absence of other chronic diseases or severe complications related to hypertension.
-
Age
-
From 60 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
62
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Patients are divided into two groups of 30 people based on regular allocation technique. First, as a simple randomization, the first referring patient takes the word "control" or "intervention" from the sealed envelope and is placed in the desired group, and with this method, concealment is done for the patient. The patient will be placed in the opposite group at the next visit. Other subsequent patients will be placed equally in the intervention and control groups. The unit of randomization is the patient and the construction method is a random sequence.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Due to the nature of the intervention, which is educational, it is not possible to blind the participants, but the help of the researcher who collects the data and the person who performs the statistical analysis will not know determine which of the intervention and control groups the patients are placed in.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-12-11, 1402/09/20
-
Ethics committee reference number
-
IR.LARUMS.REC.1402.032
Health conditions studied
1
-
Description of health condition studied
-
Elderly with primary hypertension
-
ICD-10 code
-
I10
-
ICD-10 code description
-
Essential (primary) hypertension
Primary outcomes
1
-
Description
-
Bradbent's illness perception
-
Timepoint
-
Before the intervention and the eighth week after the start of the intervention
-
Method of measurement
-
illness perception questionnaire
Intervention groups
1
-
Description
-
Intervention group: The intervention framework in this study is based on the self-regulation model of common sense(35) and the educational content will be based on the 5 dimensions of disease perception and also the effect that this model can have on the understanding of patients' disease. These dimensions include: the nature (label and symptoms of the disease), the person's belief or reason about the causes of the onset of the disease, the duration or the person's perception of the duration of the disease, the expected consequences of the person or the findings of the disease, and the effectiveness of control and recovery. Then, the patients of the intervention group are subjected to the educational program designed based on the disease understanding model for a specified period (5 weeks - one session per week). Then, immediately after the end of the intervention, the abbreviated disease perception questionnaire will be provided to the study samples (after the last session of the intervention). Sessions will last between 45 and 60 minutes. Therefore, the main content of the educational program will be the same for everyone, but according to the respondents' answers to the 5 factors of the disease understanding model, the emphasis and priority of education on these concepts will be different for each patient. The educational content collected by the research team members will be approved and evaluated by a karyologist and 2 nurse experts. At the end of each session, the educational content will be provided to the samples in the form of an educational pamphlet.
-
Category
-
Treatment - Other
2
-
Description
-
Control group: Patients who receive only the usual training and procedures of the center.
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Larestan 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
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
-
It can be shared after de-identifying people
-
When the data will become available and for how long
-
Access starts one year after results are published
-
To whom data/document is available
-
People working in academic and scientific institutions
-
Under which criteria data/document could be used
-
Subject to the agreement of Larestan Faculty of Medical Sciences
-
From where data/document is obtainable
-
Dr. Ali Mohammad Parviniyan Nesab, assistant professor of Larestan Faculty of Medical Sciences, email address: ali_parviniyan@yahoo.com, phone number: 07152255278, mobile number: 09171492744
-
What processes are involved for a request to access data/document
-
A written and official request to the Research Vice-Chancellor of Larestan Faculty of Medical Sciences
-
Comments
-