Determining the effect of self-efficacy enhancement program on medication adherence among patients with acute coronary syndrome in the Cardiac Care Unit
Design
The study is a randomized controlled clinical trial with parallel groups.
Settings and conduct
In this study, 90 patients with acute coronary syndrome admitted to the coronary Care Unit of Imam Hossein Hospital in Shahroud will be selected based on inclusion criteria and will be randomly assigned into intervention and control groups. self-efficacy enhancement program will be conducted for the intervention group. Before and 40 days after the intervention, the SEAMS questionnaire will be completed for patients in both the test and the control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age ≥ 20; speak and understand Persian language; diagnosis of Acute coronary syndrome by a cardiologist. Non inclusion criteria: Treatment-resistant ventricular arrhythmia and cardiojenic shock following illness; having a history of cognitive impairment or known anxiety disorders based on patient's history and self-declaration and doctor's approval.
Intervention groups
Intervention group: The training intervention will be performed in face-to-face form during 40 minutes to determine the acute coronary syndrome, risk factors, symptoms of heart disease and medication. Control group: they receive usual care.
Main outcome variables
medication adherence among patients with acute coronary syndromes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040204N1
Registration date:2018-08-19, 1397/05/28
Registration timing:registered_while_recruiting
Last update:2018-08-19, 1397/05/28
Update count:0
Registration date
2018-08-19, 1397/05/28
Registrant information
Name
Maryam Mahdavian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3223 9249
Email address
maryam_mahdavian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-12, 1397/05/21
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-efficacy enhancement program on medication adherence among patients with acute coronary syndromes
Public title
The effect of self-efficacy enhancement program on medication adherence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 20 or over
Ability to speak and understand Persian language
diagnosis of Acute coronary syndrome by a cardiologist.
Exclusion criteria:
Treatment-resistant ventricular arrhythmia and cardiojenic shock following illness
having a history of cognitive impairment or known anxiety disorders based on patient's history and self-declaration and doctor's approval
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by block of size 4: group A (self-efficacy enhancement program) and group B (control group). The allocation will be done concealment. In this way, there will be 90 envelopes, each with A and B codes. The envelopes will be numbered. Individuals will be coded according to their entry into the study, and will be allocated an envelope for each patient to the group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the outcome assessor (who will complete the questionnaire) and the data analyser are not aware of how the patients are allocated to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Hafte-Tir square
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2018-07-02, 1397/04/11
Ethics committee reference number
IR.SHMU.REC.1397.066
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
Description
Medication adherence score in self-efficacy for Appropriate Medication Use Scale (SEAMS).
Timepoint
medication adherence measurement as soon as the patient's condition improves. It is done before the intervention and 40 days after the intervention
Method of measurement
Self-Efficacy for Appropriate Medication Use Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The questionnaire will be completed as soon as the condition is fixed.Then, educational intervention will be provided to the patient in addition to routine therapeutic care in relation to the definition of acute coronary syndrome, risk factors, signs of heart disease and drug regimen in face-to-face form within 40 minutes.10 days later, 3 telephone follow-ups will be held for 10 minutes every 10 days, asking about follow-up treatment and medication, and diet and self-care. Then, the last 10 days follow up, Then, 10 days after the last follow-up calls (After 40 days of discharging),Telephone coordination will be done for the presence of participants in the hospital and the questionnaire will be completed again.
Category
Prevention
2
Description
Control group:The questionnaire will be completed as soon as the conditions are fixed. During this time, there will be no intervention for the participants of this group and will receive only routine and educational care at during hospitalization and and discharge time. After discharge, telephone follow up will not be done for participants, and after 40 days, while coordinating the phone to attend in the hospital, the questionnaire will be completed again.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Hoseein Ebrahimi
Street address
28th meter of Touhidi, Imam Khomeini Street
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3234 2000
Email
h_ebrahimi43@yahoo.com
Web page address
http://eh.shmu.ac.ir/home.html
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Web page address
http://research.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Ebrahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir square
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
h_ebrahimi43@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Ebrahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
3617753917
Phone
+98 232332395054
Email
h_ebrahimi43@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Ebrahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square
City
Shahroud
Province
Semnan
Postal code
36147753917
Phone
+98 23 3239 5054
Email
h_ebrahimi43@yahoo.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