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Investigating effect of correcting illness perception on adherence to therapeutic regimen and quality of life in patients with Acute Coronary Syndrome

Protocol summary

Summary
The purpose of this study is Investigating Effect of correcting illness perception on adherence to therapeutic regimen and quality of life in patients with Acute Coronary Syndrome. It’s a quasi-experimental study. Subjects of study are ACS’s patients hospitalized in CCU, Post CCU. 76 eligible patients will be enrolled in two groups. Inclusion criteria: Confirmed Acute Coronary Syndrome, ability to understand Persian, having negative illness perception, does not be under another study, doesn’t have complication of ACS, doesn’t have chronic disease, doesn’t have mental disorder, and doesn’t have cognitive disease. Exclusion criteria: Being in acute phase of disease, wouldn’t like to continue, Discharge before completing intervention. After completing informed consent, demographic information, adherence to therapeutic regimen ,quality of life and illness perception(IPQ) questionnaires in second day of admitting ,in control group without any intervention IPQ will be completed in forth day. intervention group will be done correcting illness perception intervention in 3 sessions, for consecutive days, about 30 minute in the morning shift. Then intervention group will be followed with telephone contacts at afternoons every week in first 3 weeks, next every other week until twelfth week. adherence to therapeutic regimen and quality of life questionnaires will be completed the week 3 and 12 for both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203144443N5
Registration date: 2012-04-16, 1391/01/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-04-16, 1391/01/28
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
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating effect of correcting illness perception on adherence to therapeutic regimen and quality of life in patients with Acute Coronary Syndrome
Public title
Correcting of illness perception of patients with Acute Coronary Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: • Confirmed Acute Coronary Syndrome • Ability to understand Persian • Having negative illness perception • Does not be under another study • Doesn’t have complication of ACS • Doesn’t have chronic disease • Doesn’t have mental disorder • Doesn’t have cognitive disease Exclution criteria: • Being in acute phase of disease • Wouldn’t like to continue • Discharge before completing intervention
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee Tehran University of Medical Scinces
Street address
Ghods street, Keshvarz boulevard
City
Tehran
Postal code
Approval date
2012-03-10, 1390/12/20
Ethics committee reference number
130/2471/د/90

Health conditions studied

1

Description of health condition studied
Acute ischemic heart disease, unspecified
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified

Primary outcomes

1

Description
Adherence to therapeutic regimen
Timepoint
Before intervention, 3 weeks and 3 months after intervention
Method of measurement
Adherence to therapeutic regimen questionnaire

2

Description
Quality of life
Timepoint
Before intervention, 3 weeks and 3 months after intervention
Method of measurement
Macnew quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In control group just will receive regular care, without any intervention.
Category
Other

2

Description
In intervention group, on second day of admitting ,will be done correcting illness perception intervention in 3 sessions, for consecutive days, about 30 minute in the morning shift. its exact content will be individualized according to patients’ responses on the Illness Perception Questionnaire. first session consist of a brief explanation of the pathophysiology of ACS, common symptoms, exploring the patient’s perception about the cause and factors that may have contributed to the development of the ACS, The second session build on the causes will identify by the patient and focus on developing a action plan of minimizing future risk by altering risk factors, In the third session, this action plan will be reviewed and symptoms of recovery and warning signs, Concerns the patient about their medication will be discussed and a booklet will be given. Then intervention group will be followed with telephone contacts at afternoons every week in first 3 weeks, next every other week until twelfth week.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
Eastern Nosrat street, Tohid square
City
Tehran

2

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
Northen Karegar Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Scinces
Full name of responsible person
Masoumeh Zakerimoghadam
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
Tehran University of Medical Scinces
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 Science
Full name of responsible person
Masoume Zakerimoghadam
Position
Lecturer
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 216692771
Fax
Email
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
Masoumeh Zakerimoghadam
Position
Lcturer
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Postal code
Phone
+98 216692771
Fax
Email
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 Science
Full name of responsible person
Masoumeh Zakerimoghadam
Position
lecturer
Other areas of specialty/work
Street address
Nosrat street, Tohid square
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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