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The effect of self-management program on therapeutic adherence and quality of life in patient with ischemic heart disease

Protocol summary

Summary
Objectives, the purpose of this study is investigates The effect of self-management program on therapeutic adherence and quality of life in patient with ischemic heart disease. Design, the present research took place with two group and randomized clinical trial method in intensive care unit of Rajaei Cardiac Hospital. Subjects of study will be Patients with ischemic heart disease diagnosed by a physician. 60 eligible patients enroll in two groups. Setting and conduct, in this study, patients with convenience sampling method (available) will be selected randomly (draw) and will be enrolled the study in both intervention and control groups. Inclusion criteria: Confirmed ischemic heart disease by a physician, No previous enterprises self management training. Exclusion criteria: Being in acute phase of disease, wouldn’t like to continue. Intervention, after completing informed consent, both control and experimental group will be completed pretest questionnaire of therapeutic adherence and quality of life. control group will be received regular cares but the intervention group in addition to receive the usual care, will participate in the workshop of self-management program, during the first week after discharging. This program contain a workshop, then it will be followed up by telephone once a week for 8 weeks. by the ending these eight-week, there is no defined intervention for the patients for next four weeks and finally, twelve weeks after the intervention, the questionnaire will be completed again by two control and experimental groups and differences will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504304443N19
Registration date: 2015-09-01, 1394/06/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-01, 1394/06/10
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
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management program on therapeutic adherence and quality of life in patient with ischemic heart disease
Public title
The effect of self-management program on ischemic heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:(ability to read and write; aged between 30 and 65 years; ischemic heart disease that diagnosed by physicians; traverse at least one year of diagnosis of ischemic heart disease; The absence of non cardiac chronic underlying disease that affects quality of life; No previous Enterprises self management training Exclusion criteria: The patient died during the study; The patient enters the acute phase; If the patient does not Enterprises in the telephone intervention)
Age
From 30 years old to 65 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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, patients with convenience sampling method (available) will be selected randomly (draw) and will be enrolled the study in both intervention and control groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Office building of Tehran University of medical Sciences, Keshavarz St, Tehran.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
94/د/250577

Health conditions studied

1

Description of health condition studied
Patient with ischemic heart disease
ICD-10 code
151.6
ICD-10 code description
125.0

Primary outcomes

1

Description
therapeutic adherence
Timepoint
before and 12 weeks after intervention
Method of measurement
therapeutic adherence questionair in patient with ischemic heart disease

2

Description
quality of life
Timepoint
before and 12 weeks after intervention
Method of measurement
mac new quality of life questionair

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In control group just will receive regular care at discharge include advice on medications and low salt and low-fat food, without any intervention.
Category
Other

2

Description
Intervention group : Beside receiving the usual care, the examination group will participate in self-management program which is hold with the partnership of 15 patients during sequential days, 4 hours each in the very first week after discharge. Workshops run by the researcher in the shape of educational lectures, discussions between patients and researchers, Exchange of experiences, correct the previous mistakes and finally answer the questions by researchers. The Workshop contains learning the nature of the disease, its complications, risk factors and methods of control, stress reduction techniques and methods to overcome the problems by scenario of problems and comments, share information and experiences of patients with the help of researchers, the participants will practice problem solving. The intervention focuses on increasing acceptance of medication regimen, nutrition, weight loss if needed, reducing sodium intake, regular physical activity, (walking) and quit smoking. After that for next 8 weeks, it follows-up verbal encouragement, questions and answers, improving teaching and managing disease once a week for about 10 minutes, according to research done by the patient needs. Phone calls between 8 am to 8 pm on the specified date and time will be agreed by the researcher and the research units. After the eight-week intervention for the patients for next four weeks, except very necessary will be provided by Phone call.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei Cardiac Hospital
Full name of responsible person
Masoomeh Zakeri Moghadam
Street address
Rajaei Cardiac Hospital, Niyayesh St, Valiasr St,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Scinces
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
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, 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
Masoumeh Zakerimoghadam
Position
lecturer
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 64359
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medicine
Full name of responsible person
Masoumeh Zakeri Moghadam
Position
Lcturer
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 64359
Fax
Email
zakerimo@sina.com
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
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 64359
Fax
Email
mzakerimo@sina.tums.ac.ir
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
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