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The effect of self-care education on the awareness, attitude, and adherence to self-care behaviors in hospitalized patients due to heart failure with and without depression

Protocol summary

Summary
Title: The effect of self care education on the knowledge, attitude, and adherence to self care behaviors in cardiac patients with and without depression. Objective: the effect of self care education on the knowledge, attitude, and adherence to self care behaviors in hospitalized cardiac patients with and without depression. Design: non randomized, Non blind, No placebo controlled, multi center, Phase II and III clinical trials. Method: Setting and conduct: Sample: 70 cardiac patients who met the inclusion criteria. Major inclusion criteria are: a definitive diagnosis of heart failure by cardiologist; ejection fraction Less than 40%. Major Exclusion criteria are: patients with trouble in hearing and speaking; discharge from hospital less than one week. Sample size: 70 persons. Intervention: In the intervention group, the self care behaviors will determine and then a four session educational intervention will be held individually for both groups; finally, the questionnaires will be complete again through visiting the patients at their home 12 weeks after discharge. Primary outcome: knowledge, attitude, and adherence to self care behaviors

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014082318887N4
Registration date: 2014-10-06, 1393/07/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-06, 1393/07/14
Registrant information
Name
amene barfidokht
Name of organization / entity
mashhadad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
-----
Email address
barfidokhta901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-09-20, 1392/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on the awareness, attitude, and adherence to self-care behaviors in hospitalized patients due to heart failure with and without depression
Public title
The effect of self-care education on knowledge, attitude and adherence to self-care behaviors in cardiacpatients with and without depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: definite diagnosis of heart failure according to cardiologist ,ejection fraction less than 40 based on the echocardiography, a resident of the Zahedan and Available for follow-up, at least 20 years of age, have at least literate, alert and full orientation. Exclusion criteria: patients with trouble in hearing and speaking, discharge from hospital less than one week, physical disability, dialysis, and previous participation in rehabilitation programs.
Age
From 19 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
To recruit subjects, available sampling method was used continuously for hospitalized patients during April to October 2013

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Zahedan
Street address
Dr Hesabi square, Zahedan
City
Zahedan
Postal code
9816913396
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
6054

Health conditions studied

1

Description of health condition studied
Heart diseases
ICD-10 code
I05, F32
ICD-10 code description
Chronic heart diseases, Depressive episode

Primary outcomes

1

Description
knowledge, attitude and adherence to self-care behaviors
Timepoint
Before and twelve weeks after the intervention.
Method of measurement
self-care behaviors Questionnaires

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group: The educational intervention was provided for both groups during 4 one- hours sessions through individually face-to-face training program using an educational booklet and CD.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliebne Abitaleb Hospital
Full name of responsible person
Fariba yaghoobinia
Street address
Dr Hesabi square, Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Islamic Azad University of Zahedan
Full name of responsible person
Ahmad Mehraban
Street address
Daneshgah street, Islamic Azad University
City
Zahedan
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 Islamic Azad University of Zahedan
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
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Associate Professor
Other areas of specialty/work
Street address
Mashahir square, School of Nursing and Midwifery
City
Zahedan
Postal code
9816913396
Phone
+98 54 3341 1415
Fax
+98 54 3344 2481
Email
alinavidian@gmail.com
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubinia
Position
PHD
Other areas of specialty/work
Street address
Mashair square, School of Nursing and Midwifery
City
Zahedan
Postal code
9816913396
Phone
+98 54 3343 0059
Fax
+98 54 3344 2481
Email
yaghoubinia@gmail.com
Web page address
www.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Toktam Kianian
Position
Ma
Other areas of specialty/work
Street address
Mashahir square, School of Nursing and Midwifery
City
Zahedan
Postal code
9816913396
Phone
+98 54 3343 8473
Fax
+98 54 3344 2481
Email
T.kianian67@gmail.com
Web page address
www.zaums.ac.ir

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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