Protocol summary
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Study aim
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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.
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Design
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Clinical trial with community based and pragmatic control group, with parallel group, without blindness, randomized with time block method
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Level of self-efficacy and medication adherence
General information
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Reason for update
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Update the date of completion of participant recruitment and completion of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171223038022N1
Registration date:
2018-05-20, 1397/02/30
Registration timing:
prospective
Last update:
2020-06-12, 1399/03/23
Update count:
1
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Registration date
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2018-05-20, 1397/02/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-13, 1397/01/24
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Expected recruitment end date
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2018-07-15, 1397/04/24
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Actual recruitment start date
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2018-05-22, 1397/03/01
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Actual recruitment end date
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2018-08-22, 1397/05/31
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Trial completion date
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2018-09-06, 1397/06/15
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Scientific title
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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
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Public title
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The effect of self-administration of medication program on level of self-efficacy and medication adherence
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-10, 1397/01/21
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Ethics committee reference number
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IR.MUMS.REC.1396.381
Health conditions studied
1
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Description of health condition studied
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Ischemic Heart Disease
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ICD-10 code
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I25.9
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ICD-10 code description
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Chronic Ischemic Heart Disease, Unspecified
Primary outcomes
1
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Description
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Self-Efficacy For Appropriate Medication Use
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Timepoint
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At the beginning of the study (before the intervention) and 96 hours after the intervention
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Method of measurement
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Self-Efficacy For Appropriate Medication Use scale
2
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Description
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Level of medication adherence
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Timepoint
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1 and 2 weeks after discharge
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Method of measurement
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Morisky medication adherence scale
Secondary outcomes
1
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Description
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Evaluation level of knowledge
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Timepoint
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24 after admission and upon discharge
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Method of measurement
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Instrument to evaluate the level of knowledge
2
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Description
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Assessment of patients' satisfaction with type of medication use
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Timepoint
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At the time of discharge
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Method of measurement
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Patients' Satisfaction of type of medication Use scale
3
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Description
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Nurses' Satisfaction with self-administration of medication program
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Timepoint
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At the end of the first, second and third months of study
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Method of measurement
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The Nurses 'Satisfaction from the implementation of self-administration of drug management program in the hospital instrument
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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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.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Deputy Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available