The aim of this randomized clinical trial is to evaluate the effect of family-centered and patient-centered education on self-care behaviors in patients with chronic heart failure. The study population of 120 patients with chronic heart failure hospitalized in Rajai Heart Center and active member that have inclusion criteria, which are randomly divided into three groups of patient-centered, family-centered and control. At the beginning of the study a demographic questionnaire and a questionnaire measuring self-care behaviors of patients with chronic heart failure will be completed. The family-centered that includes patients and active member will be asked to participate in three sessions about self- care education will be presented by the researcher in the hospital. In the patient-centered group, only patients participate in the same training session. In the control group, common training will be provided. After 2 months of the intervention, the researcher will be coordinate with patients to complete this questionnaire again. The self-care behaviors and baseline groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071823159N3
Registration date:2015-09-27, 1394/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-27, 1394/07/05
Registrant information
Name
Alice Khachian
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
khachian.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research funding of Iran University of medical sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of family centered and patient centered education on Chronic heart failure patient’s self care behaviors
Public title
The effect of education on on Chronic heart failure patient’s self care behaviors
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; Confirmed diagnosis of heart failure by the doctors (in their medical records); Patients with heart failure with ejection fraction of 35% or less ;Non acute conditions
The absence of disabilities - cognitive impairment of vision, hearing and communication; People's willingness to participate in this study; Having caregivers (family members) that have inclusion criteria.
Family caregivers criteria for inclusion: family caregivers have a minimum education (reading and writing); willingness to participate in the study; patient care should be at least three months and those who have assumed responsibility for patient care.
Exclusion criteria: absence of more than one of the training sessions for groups
; wanting to stay in the study for both groups; Fatal; worsening of the patient's condition; transfer to another ward; prolonged hospital stay (more than 1 month); People who score high on self-care questionnaires were received before the intervention; Participating in the same study
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethic committee of Iran University Of Medical sience
Street address
Iran University of Medical Sciences -Hemat Highway
City
Tehran
Postal code
Approval date
2015-05-03, 1394/02/13
Ethics committee reference number
105/632 / د/Ir.iums.ric.1394.94
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.0
ICD-10 code description
Heart failure
Primary outcomes
1
Description
The self-care behaviors
Timepoint
Before and 2 Month after intervention
Method of measurement
self care behavior of paitent with heart failure questinner
Secondary outcomes
empty
Intervention groups
1
Description
Family-centered group that, including the patient and his active member of family will be asked in the three educational sessions on topics related to self care, including the introduction of disease, chronic heart failure, risk factors, symptoms, diet, exercise appropriate medical treatment and proper care and management of the disease that the researcher will participate in the hospital. Each session lasted 45 minutes and will be scheduled according to the needs of patients and their family members may continue for up to 60 minutes. The teaching methods and, if possible, as a group with a maximum number of 10 participants will be accompanied by questions and answers and images.
Category
Lifestyle
2
Description
In patient-centered group that only patients participate in the training session educational content will be the. Educational content will be the same in both groups, the content includes the introduction of chronic heart failure, risk factors, symptoms, diet, proper exercise, proper medication and self-care and management of the disease.
Category
Lifestyle
3
Description
The control patients will receive training in common hospital care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei Cardiovascular, Medical & Research Center
Full name of responsible person
Nasim Naderi
Street address
next to Mellat Park, Vali Asr st, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Room #503, 5th floor, Central building of Iran University of Medical Sciences, between Chamran and Hemmat Expways, Hemmat Expway
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, Iran 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fereshteh Aghamohamadi
Position
Nursing Msc Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran, Rashid Yasemi st, No 6., Vali-e-asr Ave
City
Tehran
Postal code
1996713883
Phone
00
Fax
Email
fa4768@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Alice Khachian
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran, Rashid Yasemi st, No 6., Vali-e-asr Ave
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
alicekhachian@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fereshteh Aghamohamadi
Position
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran, Rashid Yasemi st, No 6., Vali-e-asr Ave
City
Tehran
Postal code
1996713883
Phone
00
Fax
Email
fa4768@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)