This study will be conducted to investigate the effect of education based on family-centered empowerment model on adherence to anticoagulant regimen treatmentin patients with prosthetic heart valve. This clinical trial study will be conductedon 60 patients and 30 family members (in intervention groups) in open-heart surgery of Imam Reza (AS) Hospital of Mashhad. Patients were selected using available sampling method and they were randomly divided into intervention and control groups. For intervention group, family-centered empowerment modelwill be conducted with four steps (to improve knowledge, self-efficacy, self-esteem, and evaluation) through individual instruction, group discussions, and question and answer. The control group received only one training session on the day of their discharge from the hospital. After 1.5 months,adherence to anticoagulant regiment treatmentin both groups (intervention and control) will be investigated and the data will be analyzed using SPSS 16 software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100624395N1
Registration date:2015-12-30, 1394/10/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Maryam Mohammadpour Ostad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1513
Email address
mohammadpoorm2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences (90%) and the Research Center for Evidence-based care (10%)
Expected recruitment start date
2015-08-21, 1394/05/30
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on the family-centered empowerment model on anticoagulant adherence of patients with prosthetic heart valve.
Public title
The effect of education based on the family-centered empowerment model on anticoagulant adherence of patients with prosthetic heart valve.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study ; The age range of 65- 18 years; living in Mashhad; Artificial valve replacement surgery;The first shift valve replacement surgery; Failure to develop an advanced chronic disease (stroke, kidney failure) and lack cognitive and mental disorders (Alzheimer's, depression); Loss of speech and hearing problems; Having read and write; The patient has no health personnel; A family member (spouse, child, sister, etc.) that further cooperation in the field of health -care and the patient is Family members living with the patient; Lack of family members to valve disease
Inclusion criteria 10,11 and 12 will be considered for patients in the intervention group.
Inclusion criteria of active member of the family: willingness to participate in research; having read and write; lack of drug addiction; without the risk of heart valve disease; Is not of Health care worker
Exclusion criteria: unwillingness of research or a member of his family to cooperate at every stage of research; hospitalization for any reason at any stage of research; changes in the anticoagulant medication; The incidence of postoperative complications requiring surgery, physical or mental problems that lead to disability at any stage of the research.
Age
From 18 years old to 60 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology, Mashhad University of Science, next to the Hovyzeh cinema, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2015-09-26, 1394/07/04
Ethics committee reference number
IR.MUMS.REC.1394.414
Health conditions studied
1
Description of health condition studied
Valvular heart disease
ICD-10 code
I39
ICD-10 code description
Endocarditis and Heart valve Disorders in Diseases Classified Elsewhere
Primary outcomes
1
Description
Adherence to anticoagulant treatment regimen
Timepoint
one and half month after intervention
Method of measurement
Questionnaire of Adherence to anticoagulant treatment regimen
Secondary outcomes
1
Description
bleeding
Timepoint
Three months after intervention
Method of measurement
Landfield questionnaire
Intervention groups
1
Description
The education will be implemented based on the family-centered empowerment model steps as follows: 1- the first step is to increase the participants’ perceived threat (severity and susceptibility). The perceived severity means to understand the risk of the absence of proper caring behavior and the perceived susceptibility means to comprehend how a person is at risk for the diseases resulting from lack of proper caring behavior. Thus, by Two 45-60 minute sessions by Individual Training, group discussions and question and answer that will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). 2- the second step is problem solving. Problem solving will be conducted via group discussions in a manner that promotes the participants' self-esteem. The goal of this step is understanding the problems providing their solutions. The problem-solving sessions will hold in one 45-60minute small group discussions under supervision of the researcher in discharging day. In these sessions, some objective examples of their problems with the caring behaviors will be presented. Then, the researcher conducts the group-discussion and let them to modify their wrong caring behaviors. At this stage, the caregivers get practically familiar with their problems and their solving process. This issue will enhance their self-efficacy. 3- the third step is participation in the training. In this step, the patient transfer the discussed topics in the previous meetings by the pamphlets and a booklet to active member of the family. 4- the fourth step is evaluation. It includes two stages, process evaluation and final evaluation. The final evaluation will be performed 1.5 months after discharge.
Category
Prevention
2
Description
In the control group will be provided to patients and family members one training session 60-45 minutes in discharge day.