The effect of self-administration of medication program on level of self-efficacy and medication adherence of patients with ischemic heart disease admitted in cardiac unit
Determine the effect of self-administration of medication program on self-efficacy and medication adherence of patients with ischemic heart disease admitted in the cardiac unit.
Design
Clinical trial with community based and pragmatic control group, with parallel group, without blindness, randomized with time block method
Settings and conduct
Patients with ischemic heart disease hospitalized in the Imam Reza hospital (AS) will be randomly selected and randomly assigned to the intervention and control groups (with time block in the selected section). In the intervention group, the self-administration of medication program will be performed in three steps. In the control group, the medication education and medication Consumption is routinely provided by the nurse in the same period. Pharmaceutical knowledge and self-efficacy in both groups will be checked before and after the intervention. The medication adherence will be measured 1 and 2 weeks after discharge by telephone.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Be alert.
Diagnosis of ischemic heart disease.
No cognitive or psychological problem according to medical records.
Have at least primary education.
There is a tendency to take medications by the patient himself.
Predict long-term (at least 6 months) consumption of two or more tablets at the time of discharge.
Having a phone number to make calls after the discharge
Non-entry criteria:
Discharge to a nursing home or a rehab center, or wherever that cause to patient deprivation of self-administration of medication.
Unwillingness to follow-up with telephone after discharge.
Intervention groups
Patients with ischemic heart disease admitted in cardiac unit under self-administration of medication program for 96 hour.In the control group, the use of medication will be done routinely.
Main outcome variables
Level of self-efficacy and medication adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171223038022N1
Registration date:2018-05-20, 1397/02/30
Registration timing:registered_while_recruiting
Last update:2018-05-20, 1397/02/30
Update count:1
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
reza Haji ali beigloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3372 0518
Email address
hajialibr951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-13, 1397/01/24
Expected recruitment end date
2018-07-15, 1397/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-administration of medication program on level of self-efficacy and medication adherence of patients with ischemic heart disease admitted in cardiac unit
Public title
The effect of self-administration of medication program on level of self-efficacy and medication adherence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be alert
Diagnosis of ischemic heart disease is confirmed by clinical signs, ECG and enzyme tests by a cardiologist.
No cognitive or psychological problem according to medical records.
Do not have audible(Complete hearing despite the use of aids) and visual(Ability to read newspaper at a distance of 30 cm with glasses )problems.
Age under the 60 and over 18.
Have at least primary education level.
There is a tendency to take medications by the patient himself.
Predict long-term (at least 6 months) consumption of two or more tablets at the time of discharge.
Having a phone number to make calls after the discharge
Exclusion criteria:
Discharge to a nursing home or a rehab center, or wherever that cause patient deprivation of self-administration of medication.
Unwillingness to follow-up with telephone after discharge.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The research units according to the sequences that generated by SPSS software before the start of the study were randomly divided into intervention and control groups. In order to prevent the dissemination of information between the two groups, patients in the same room in two groups will not be used.
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 Mashhad University of Medical Sciences
Street address
next to Hoveyze Cinema,opposite street,University 18-University Street -
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-04-10, 1397/01/21
Ethics committee reference number
IR.MUMS.REC.1396.381
Health conditions studied
1
Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic Ischemic Heart Disease, Unspecified
Primary outcomes
1
Description
Self-Efficacy For Appropriate Medication Use
Timepoint
At the beginning of the study (before the intervention) and 96 hours after the intervention
Method of measurement
Self-Efficacy For Appropriate Medication Use scale
2
Description
Level of medication adherence
Timepoint
1 and 2 weeks after discharge
Method of measurement
Morisky medication adherence scale
Secondary outcomes
1
Description
Evaluation level of knowledge
Timepoint
24 after admission and upon discharge
Method of measurement
Instrument to evaluate the level of knowledge
2
Description
Assessment of patients' satisfaction with type of medication use
Timepoint
At the time of discharge
Method of measurement
Patients' Satisfaction of type of medication Use scale
3
Description
Nurses' Satisfaction with self-administration of medication program
Timepoint
At the end of the first, second and third months of study
Method of measurement
The Nurses 'Satisfaction from the implementation of self-administration of drug management program in the hospital instrument
Intervention groups
1
Description
Intervention group: In the intervention group, in the first 24 hours, the nurse will be responsible for providing medications and training of medication administration.This training will include the name of the medication, the dosage, the method and timing of the medication, the cause of medication use and possible side effects for the patient.Brochures for each medication will be provided to patients in order to further training.Immediately after completing this stage, the patient's ability to start the second phase is assessed by the checklist number one and, if it is eligible, will enter the second stage of the program.At this stage (second step), the next 24 hours of the patient's medicine will be placed inside a special box that will be available to the patient and can be locked, and the numbered key is provided to nurses at a special place at the nursing station.Then, according to the trained patient in the first stage, the patient will ask his nurse at the appropriate time. After nurse presence, he will remove the relevant medications from the box and will use it with direct supervision of the nurse and after confirmation of the correctness of the medication taken.If needed, blood pressure, pulse, and other vital signs will be controlled by the nurse before taking the medicine, and the patient will be given appropriate training in this regard.Furthermore, the nurse will provide a checklist for patient that named "used medication checklist" to complete the list after taking the medication.This checklist is designed to ensure that the correct medication is taken at the right time. This checklist is also provided to prevent the medication from being missed or reused because of doubt about the use of the medication and will be seen by the nurse in each shift.If the patient delays the authorization for medication use for 1 hour medication consumption will be reminded and This issue is considered as the first indication of lack of readiness and if it happen in next time, patient will comeback to first step and will use his medication with nurse help.This process is repeated up to 2 times and if the patient is unable to take medication by himself, he will be excluded from the study.At the end of the 24th hour (second stage), the amount of the ability, competence and adequacy of medication use is assessed by the checklist number 3.If used correctly and on time, these medication at the end of the 24 hour second (according to checklist 3), the patient's next 48 hours medication is placed in the patient's personal box and a copy of the key is given to him and the patient will be responsible for keeping the key to himself and taking Medications and the nurse will be responsible for indirect control by counting the pills.This count will take place at certain hours (6:30 am, 12:30 and 6:30 PM).At this stage, the patient will be required to complete a checklist of consumed medications to prevent any of mentioned problems and the checklist will be controlled by the nurse.Possible errors will be recorded and reported at this stage.
Category
Other
2
Description
Control group: In the control group, the medications are given to the patients by the nurse, and patients will receive routine drug training during admission and at the time of discharge.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyed Reza Mazlom
Street address
Imam Reza Square,Ebne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazlom
Street address
University ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vpresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Haji Ali Beigloo
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus University,End of Shahid Bahonar Blvd ,Vakil Abad 2 ,Vakil Abad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 936 186 6829
Email
rezahajialibeigloo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Haji Ali Beigloo
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus University,End of Shahid Bahonar Blvd ,Vakil Abad 2 ,Vakil Abad
City
MASHHAD
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 936 186 6829
Email
rezahajialibeigloo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Haji Ali Beigloo
Position
Master of Science in Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 110, Payam Ave., Heydar Baba Blvd.,Shahriar Town
City
Urmia
Province
West Azarbaijan
Postal code
9177948988
Phone
+98 44 3372 0518
Fax
Email
hajialibr951@mums.ac.ir
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
No more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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