Protocol summary

Summary
The project aims to investigate the impact of family-centered empowerment model on self-care of patients with prosthetic heart valve. Family-centered empowerment model designed to emphasis on the role of patients and family members to be effective. In this study, after that the proposal approved in the university, an assessment tool provided by the researcher. In this quasi-experimental study 40 patients were selected by available method and divided two groups( test group and control group). Intervention in test group has four steps: In first step, I am going to have meetings with the aim of perceived threat, by increasing the level of knowledge and understanding. In the second step, problem-solving is as a method of problem- solving group study will have done to increase self-efficacy, self-esteem and self-control in patients. In the third step, from the patients ask participate in training their family members. Each session an educational card will have sent for family training with participants. A week after the intervention patients self-care will have measured by above instrument. Then one and half months will have given time to the patient and family members to performance the model. Then self-care will have evaluated with the tool. In the control group, after doing pre- test, we will have done post-test after one and half month passed, Then The control group will have measured. In the end, both groups will have analyzed and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015083120041N2
Registration date: 2016-03-31, 1395/01/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-31, 1395/01/12
Registrant information
Name
Armin Zareiyan
Name of organization / entity
Military University of Medical Science (AJA)
Country
Iran (Islamic Republic of)
Phone
+98 21 7765 4000
Email address
a.zareian@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA University of Medical Sciences
Expected recruitment start date
2015-10-29, 1394/08/07
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Family-Centered Empowerment Model (FCEM) on self-care of the patient with prosthetic cardiac valve in armed forces hospitals.
Public title
The effect of Family-Centered Empowerment Model (FCEM) on self-care of the patient with prosthetic heart valve in armed forces hospitals.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having at least one artificial heart valve; embedded artificial heart valves for the first time; age between 18 -85 years old; 72 hours after cardiac surgery; ability to read and write by the patient or family member participating in patient care; access patient or family member participate for phone; patients have the ability to communicate and hard; lack of mental disorder and amnesia; the patient or family member participate not have been a doctor or nurse; lack of underlying incurable disease. Exclusion criteria: withdrew from further participation in the study or patient death; the unavailability of the patient after discharge.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a quasi-experimental study. It has a control group. Patients were selected if available. Hospital chose base on doing heart valve surgery.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, Etemadzadeh St., Fatemi St., Tehran. .
City
Tehran
Postal code
Approval date
2015-10-26, 1394/08/04
Ethics committee reference number
IR.AJAUMS.REC.1394.40

Health conditions studied

1

Description of health condition studied
Heart valve replacement
ICD-10 code
Z95.4
ICD-10 code description
Presence of heart -valve replacement

Primary outcomes

1

Description
Self-care
Timepoint
Before intervention and one and half months after intervention
Method of measurement
Questionnaire prepared by researcher

Secondary outcomes

empty

Intervention groups

1

Description
Test group:1) Pre test; 2) performance of four step: In first step, I am going to have meetings with the aim of perceived threat, by increasing the level of knowledge and understanding. In the second step, problem-solving is as a method of problem- solving group study will have done to increase self-efficacy, self-esteem and self-control in patients. In the third step, from the patients ask participate in training their family members. Each session an educational card will have sent for family training with participants.In the fourth step, a week after the intervention patients self-care will have measured by above instrument. Then one and half months will have given time to the patient and family members to performance the model. Then self-care will have evaluated with the tool.
Category
Lifestyle

2

Description
In the control group, after doing pre- test, we will have done post-test after one and half month passed, Then The control group will have measured. In the end, both groups will have analyzed and compared.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Jamaran Haspital
Full name of responsible person
Abedini Fahimh
Street address
Jamaran Haspital, Jamaran St., Bahonar St., Thran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Abedini Fahimh
Street address
AJA University of Medical Sciences, Etemadzadh St, Fatmi St, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA 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
AJA University of Medical Sciences
Full name of responsible person
Abedini Fahimeh
Position
MSc student
Other areas of specialty/work
Street address
AJA University of Medical Sciences, Etmadzadh St., Fatmi St., Thran.
City
Tehran
Postal code
Phone
+98 21 7750 0201
Fax
Email
fa.23.abedini@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Abedini Fahimeh
Position
MSc student
Other areas of specialty/work
Street address
AJA University of Medical Sciences, Etemadzadeh St., Fatemi St.
City
Tehran
Postal code
Phone
+98 21 7750 0201
Fax
Email
fa.23.abedini@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Abedini Fahimeh
Position
MSc Student
Other areas of specialty/work
Street address
AJA University of Medical Sciences, Etemadzadeh St., Fatemi St.
City
Tehran
Postal code
Phone
+98 21 7750 0201
Fax
Email
fa.23.abedini@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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