This study is a randomized clinical trial which aims to determine the effect of family-centered empowerment model on dignity in patients with heart failure in patients admitted to intensive care and heart wards FatemeZahr hospital in Sari and ValiAsr in Ghaemshahr takes place in the year 1396.In this study 80 patients of the study population based on the criteria and sampling will be chosen and the application randomization patients will be grouped according to four blocks in the two groups 1 and 2.Randomly number 1 in the empowerment group and number 2 in the control group will be dedicated.After selecting any of the samples and then explain the purpose of the study and informed consent demographic,social status and inherent dignity for patients in both groups will be completed.In group 1 the family-centered empowerment model will be taught in four steps:understanding the threat,self efficacy,self esteem and evaluation.In group 2 will not be a special intervention and routine will be done for them.Before and after the intervention using data collected will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703223064N7
Registration date:2017-04-18, 1396/01/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-18, 1396/01/29
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research - Shahroud University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family-centered empowerment model on dignity of patients with heart failure
Public title
Effect of empowerment model on dignity of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients older than 40 years; informed written consent; the absence of mental illness or drugs influencing the mental; ability to read and write; understand and speak Persian; passing at least one month of diagnosis of heart failure; the possibility to make phone calls with patient
Exclusion criteria: the reluctance of patients to continue treatment; failure patients to continue treatment due to disease progression or death
Age
From 40 years old to 85 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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
ir.shmu.rec.1395.186
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Patients dignity
Timepoint
Before intervention-A month after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the control group of 40 patients will be randomly selected they will be given training routine and before and one month after the intervention will evaluate patients dignity.
Category
Other
2
Description
In the study group,40 patients were randomly selected and family-centered empowerment model they will be taught in 4 stages:1-Understanding the threat:Treatment by raising the level of knowledge about the nature and risk of complications from the disease in group discussion is presented.The contents of the meeting includes the evaluation of physical and mental conditions of the participants as well as their attitude towards the nature of the disease,by definition,warning signs,nursing and medical care and complications of the disease.(through 3-5 sessions,including 3-5 patients with a family member and each sessions takes about 45-60 minutes)
2-Self efficacy:problem solving group study in groups of 3-5 people during the 3-5 one-hour sessions will be held for patients and patients with problems and the process of solving the problem encountered and their participation in the selection of solutions.
3-Self-esteem:patients through the use of problem-solving from the previous steps to achieve a practical solution.
4-Assessment:The entire process takes place one month after the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr hospital
Full name of responsible person
Mamak ghobadi
Street address
Mazandaran-Ghaemshahr-Sari street
City
Ghaemshahr
2
Recruitment center
Name of recruitment center
Fateme Zahra hospital
Full name of responsible person
Mamak ghobadi
Street address
Army Blvd-next to court
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research - Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammad-Hassan Emamian
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
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 - Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
PhD in nursing education
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
bagheri@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
PhD in nursing education
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
bagheri@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
PhD in nursing education
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)