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
This study is done to the investigate effect of empowerment program on perception of risk and health dimensions in patients with coronary heart disease. This study is clinical trial, randomized, available sample and permuted block randomization method, sample volume 84 person( each group 42 person). 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. By drawing lots between the two hospitals where the research is conducted, one place is allocated to test group and other to control group. On reaching the semi- study, for create equal conditions, groups study place is replaced. 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607254443N22
Registration date:2017-06-30, 1396/04/09
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputyof Tehran University of Medical Sciense
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
ٍEffect of empowerment program on the perception of risk and health dimensions in patients with coronary heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
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; No psychological problems; No participate in the empowerment of similar; being in stable condition. Exclusion criteria: appearance the acute phase of illness and patient death; No participate in one of the workshop sessions/ or in follow-up telephone.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Ghods street, Keshvarz boulevard
City
Tehran
Postal code
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2691
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
perception of risk
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
the perception of risk of heart disease scale(PRHDS)
2
Description
physical health
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Seattle Angina Questionnaire(SAQ)
3
Description
life satisfaction
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Life Engagement Test(LET)
4
Description
life orientation
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Revised Life Orientation Test(LOT-R)
5
Description
optimism
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Revised Life Orientation Test(LOT-R)
Secondary outcomes
empty
Intervention groups
1
Description
In control group no intervention is conducted by researcher and patients receive routine cares of the ward.
Category
Other
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Zakerimoqhadam masoumeh
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
shariati hospital
Full name of responsible person
Zakerimoqhadam masoumeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Nursing education PHD, Faculty member
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical Sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Nursing education PHD، Faculty member
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical Sciences
Full name of responsible person
Zakeromoghadam Masoumeh
Position
Nursing education PHD, Faculty member
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)