Protocol summary

Summary
This study will be done with aim to investigate the effect of group discussion on self-care ability and self-esteem in patients with heart failure admitted to Imam Ali hospital of Kermanshah.This is a non- blinded clinical trial. The study population will include all patients with heart failure that willreferred to Imam Ali Hospital in Kermanshah. A total of 80 individuals will selected in available method and on the basis of random tables will beassigned in and control groups.At baseline Rosenberg Self-Esteem questionnaire and European scale of self-care behavior will be provided for both experimental and control groups.The intervention group will be divided into three classes 10 to 15person.The experimental group will received 8 sessions of group discussion (every week one session).The control group will receive only routine interventions of hospital.After a month Rosenberg Self-Esteem questionnaire and European scale of self-care behavior will be provided for both groups and self-care ability and self-esteem in both groups will compared. Inclusion criteria: Having functional class III and IV New York Heart Association; Diagnosis of heart failure at least six months ago, Minimum age 18 years and maximum 65 years; Can read and write; Lack of private nurse, Lack of work experience in hospitals; Lack of hearing and vision disorders. Exclusion criteria:Absence in the more than 25% of classes The effect of group discussion on the clients' self esteem and self-care ability with heart failure disease referred to Imam Ali hospital in Kermanshah

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010514333N63
Registration date: 2017-01-22, 1395/11/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-01-14, 1395/10/25
Expected recruitment end date
2017-04-14, 1396/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness and non-effectiveness of group discussion on self-care ability and self-esteem in patients with heart failure admitted to Imam Alihospital of Kermanshah
Public title
The effect of group discussion on the clients' self esteem and self-care ability with heart failure disease referred to Imam Ali hospital in Kermanshah
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having functional class III and IV New York Heart Association; Diagnosis of heart failure at least six months ago, Minimum age 18 years and maximum 65 years; Can read and write; Lack of private nurse, Lack of work experience in hospitals; Lack of hearing and vision disorders. Exclusion criteria: Absence in the more than 25% of classes
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
kums.rec.1395.446

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
150.9
ICD-10 code description
Cardiac, heart or myocardial failure NOS

Primary outcomes

1

Description
Self-esteem
Timepoint
Baseline, one month after the end of the study
Method of measurement
Based on Rosenberg Self-Esteem questionnaire

2

Description
Self-Care
Timepoint
Baseline, one month after the end of the study
Method of measurement
Based on Rosenberg Self-Esteem questionnaire and European scale of self-care behavior

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will received 8 sessions of group discussion (every week one session).
Category
Behavior

2

Description
The control group will receive only routine interventions of hospital
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Maryam Ahmadi
Street address
Emam Ali Hospital, Shahid Beheshtir Boulevard
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ahmad Khoshay
Position
Master of Nursing, Internal Surgical trends
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Dolatabad Boulvard, Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3826 6429
Fax
Email
akhoshay@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Dolatabad Boulvard, Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3826 6429
Fax
Email
m.ahmadi6393@gmail.com
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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