Protocol summary
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Study aim
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the investigate effect of empowerment program on perception of risk and health dimensions in patients with coronary heart disease
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Design
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clinical trial, randomized, available sample and Block Balanced Randomization (BBR) method
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Settings and conduct
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The present study is carried out in the Post CCU offices of Tehran Heart Center. Assignment of patients in two groups of test and control was done by Block Balanced Randomization method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com. By obtaining a written consent indicating voluntary participation and prior to commencement of intervention, demographic and disease questionnaire and perception of risk and health dimensions questionnaire is completed by two groups. Intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital. Control group receives routine cares of the ward. Then, at the end of intervention, the perception of risk and health dimensions questionnaire is completed by the patient in two groups. MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
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Participants/Inclusion and exclusion criteria
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Patients with age of 18 to 65 years and ability of read and write can participate in study and they are omitted from the study upon appearance the acute phase of illness and patient death.
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Intervention groups
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patients with coronary heart disease
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Main outcome variables
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empowerment program
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201607254443N22
Registration date:
2017-06-30, 1396/04/09
Registration timing:
prospective
Last update:
2018-01-01, 1396/10/11
Update count:
1
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Registration date
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2017-06-30, 1396/04/09
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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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Research Deputyof Tehran University of Medical Sciense
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Expected recruitment start date
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2017-07-23, 1396/05/01
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Expected recruitment end date
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2017-09-23, 1396/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial comparing the effectiveness of empowerment program on the perception of risk and health dimensions in two groups of patients with coronary heart disease
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Public title
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ٍEffect of empowerment program on the perception of risk and health dimensions in patients with coronary heart disease
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
adult 18-65 years; least ability to read and write; diagnosis of ischemic heart disease through diagnostic tests and physician; Ability to communicate; being in stable condition.
Exclusion criteria:
psychological problems; participate in the empowerment of similar.
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Age
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No age limit
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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:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com.
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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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2017-06-19, 1396/03/29
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Ethics committee reference number
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IR.TUMS.FNM.REC.1396.2691
Health conditions studied
1
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Description of health condition studied
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coronary artery disease
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ICD-10 code
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125.1
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ICD-10 code description
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Atherosclerotic heart disease
Primary outcomes
1
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Description
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perception of risk
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Timepoint
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Before the the intervention, immediately after ending the intervention
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Method of measurement
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the perception of risk of heart disease scale(PRHDS)
2
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Description
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physical health
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Timepoint
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Before the the intervention, immediately after ending the intervention
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Method of measurement
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Seattle Angina Questionnaire(SAQ)
3
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Description
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life satisfaction
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Timepoint
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Before the the intervention, immediately after ending the intervention
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Method of measurement
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Life Engagement Test(LET)
4
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Description
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life orientation
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Timepoint
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Before the the intervention, immediately after ending the intervention
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Method of measurement
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Revised Life Orientation Test(LOT-R)
5
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Description
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optimism
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Timepoint
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Before the the intervention, immediately after ending the intervention
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Method of measurement
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Revised Life Orientation Test(LOT-R)
Intervention groups
1
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Description
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In control group no intervention is conducted by researcher and patients receive routine cares of the ward.
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Category
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Other
2
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Description
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In test group, intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital.
MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
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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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Vice chancellor for research of Tehran 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available