Determining the effectiveness of health literacy intervention on awareness, medication adherence and blood pressure in patients with ischemic heart
Design
A randomized, single-blinding clinical trial, with the parallel groups, Phase 3 on 100 patients
Settings and conduct
In this randomized, single-blind clinical trial study, 100 eligible patients will be included in the study under the coverage of Isfahan health and treatment centers and will be randomly divided into two groups. The patients in the first group will be under health literacy educational intervention and the patients in the second group will be without education. Then the level of acknowledgement, medication adherence and blood pressure levels of the patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria in the study include patients with cardiac ischemia, in the age group of 30 to 65 years, and who are willing to participate in the study.
Exclusion criteria include lack of literacy and less than one year of disease onset.
Intervention groups
Control group: patients in this group will not undergo any educational intervention.
Intervention group: Patients in this group will undergo health literacy training during five 60-minute training sessions.
Effectiveness of health literacy intervention on awareness, medication adherence and blood pressure levels in rural patients with cardiac ischemia
Public title
Effectiveness of health literacy intervention on awareness, medication adherence and blood pressure in patients with cardiac ischemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cardiac ischemia
Age category 30 to 65 years
Consent to participate in the study
Exclusion criteria:
Lack of literacy
Less than one year of disease onset
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 100 eligible patients are randomly selected. For this, the letter A is written on 50 sheets, the letter B is written on 50 sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the nature of the present study and conducting the educational intervention in only one group, the interventionist and the patient are aware of the type of intervention in each group, but the investigator and the statistical analyst will not be aware of the type of intervention in each group.
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.MUI.MED.REC.1398.260
Health conditions studied
1
Description of health condition studied
Ischemic heart
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Drug knowledge
Timepoint
Before and 1 month after the educational intervention
Method of measurement
Questionnaire
2
Description
Adherence to treatment
Timepoint
Before and 1 month after the educational intervention
Method of measurement
Questionnaire
3
Description
Blood pressure
Timepoint
Before and 1 month after the educational intervention
Method of measurement
Sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: patients in this group will not undergo any educational intervention
Category
N/A
2
Description
Intervention group: Patients in this group will undergo health literacy training during five 60-minute training sessions.In this way, in the first session, the patient is introduced. In the second session, after a brief review of the previous session and encouraging the patients; There will be a discussion about the disease and their medicines and the effect of the medicine for them. In the third session, after a short review of the previous session using questions and answers from the patients; The patients are requested to explain how to take their medicines and express their experiences regarding how to take the medicine and the feedback they have had in this regard in the meeting. In the fourth session, after a brief review of the previous session and the importance of correct drug use, the serious side effects of these drugs are discussed and an attempt is made to familiarize the patients with the symptoms of these side effects. In the fifth session, after a short review of the previous session and a discussion about the questions that have arisen for the patients and solving their needs and solving their stress and uncertainties; Finally, the therapeutic purpose of using these drugs will be stated.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Health Center
Full name of responsible person
Arash Najimi
Street address
Faiz Street, Sheikh Mofid Street
City
Isfahan
Province
Isfehan
Postal code
8164969459
Phone
+98 31 3661 7371
Email
najimiarash@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Soheila Amini
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Faculty of Medicine, Department of Family Medicine
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 8092
Email
soheila.amini120@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Amini
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Faculty of Medicine, Department of Family Medicine
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 8092
Email
soheila.amini120@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Amini
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Family Physician
Street address
Faculty of Medicine, Department of Family Medicine
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 8092
Email
soheila.amini120@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