Determining the effect of family-centered empowerment model on resilience and care pressure of family caregivers of patients undergoing hemodialysis in Imam Khomeini Hospital in Kermanshah in 1400
Design
A clinical trial with a control group was randomized with parallel, one-way blind groups. The samples will be selected using a table of random numbers and then divided into two groups of control and a 30-member intervention group using a simple random method by lottery. The intervention group is then divided into 5 groups of 6 people.
Settings and conduct
The research environment is the hemodialysis ward of Imam Khomeini Hospital in Kermanshah.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A caregiver who is involved in patient care for at least 4 hours a day and spends most of his time with the patient (according to the patient's opinion). Not having medical jobs. The age of the patient and the patient should be between 18-65 years.
Conditions for not entering the study: Absence of family caregiver in two sessions of empowerment training. Diagnosis of a new illness for the patient. Having mental illness or anxiety disorders in the family caregiver.
Intervention groups
The implementation steps of this model include four steps: 1- Perception perceived through group discussion, 2- Promoting self-efficacy through group problem solving and practical demonstration, 3- Increasing self-esteem (self-confidence) and self-control through educational participation, and 4- Evaluation including evaluation The process and evaluation is final. Before and after intervention, the care pressure and resilience questionnaire section will be completed by the patient's family.
Main outcome variables
The main consequence is the mean score of resilience and care pressure in the intervention group before and after the program.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211102052943N1
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Farnaz Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3843 3755
Email address
kiani.farnaz@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on resilience and care burden of caregivers of hemodialysis patients
Public title
The effect of family-centered empowerment model on resilience and care burden of caregivers of hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A caregiver who is involved in patient care for at least 4 hours a day and spends the most time with the patient (according to the patient).
Lack of medical jobs in the patient.
The patient is willing to participate in the research.
The patient has the ability to learn.
The age of caregiver should be between 18-65 years.
The age of patient should be between 18-65 years.
Lack of medical jobs in caregiver.
The caregiver is willing to participate in the research.
The patient caregiver has the ability to learn.
Exclusion criteria:
mental illness or anxiety disorders in the family caregiver.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected using a random number table and then divided into two control groups and a 30-member intervention group using a simple random method. In the first stage:
1. The names of the complete definition community are listed.
2- Each member is assigned a number.
3- A table of random numbers is prepared.
4- A row and column from the table of random numbers are selected as the starting point.
5- The digits on the left of the column and the selected row are selected according to the number of the desired population.
6- Numbers that are less than or equal to the target population and continue until the sample is completed.
And in the second stage:
Samples are divided into control group and intervention group by random selection of each sample through lottery.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, the statistical analyst does not know how to assign individuals to the intervention group and the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
islamic azad university najafabad branch
Street address
University Boulevard, Islamic Azad University, Najafabad Branch
City
najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2021-10-28, 1400/08/06
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1400.165
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Resilience score in Connor and Davidson Resilience Questionnaire
Timepoint
The resilience questionnaire will be completed by the patient's family before and after the intervention.
Method of measurement
Connor and Davidson Resilience Questionnaire
2
Description
Care pressure score in Zarit questionnaire
Timepoint
Before and after the intervention, the care pressure questionnaire will be completed by the patient's family.
Method of measurement
Zariat Care Pressure Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention group is divided into 5 groups of 6 people and the schedule is scheduled in 4 sessions of 90 minutes for 4 weeks, in group sessions, with the active participation of the patient and a family member (at least the main caregiver of the family). Discussion and question and answer will be done by the researcher in the dialysis ward of the hospital using teaching aids, including whiteboard, PowerPoint. Step 1 (Understanding the threat): This step in two 90-minute sessions by the researcher Through lectures and group discussions with the aim of increasing knowledge and cognition and then understanding the threat by becoming aware of the nature and effects, aggravating factors, nutritional factors, exercise and effective factors in controlling the disease will be implemented. Problem solving or self-efficacy): This step is performed by group discussion in two 90-minute sessions. In this section, patients are practically faced with their problems and problem-solving process and will benefit from each other's experiences in order to solve the problems caused by the disease and better control it. At this stage, the best way to solve patients' problems is selected and about nutrition, healthy and correct physical activity and its relationship with disease control and dialysis and related points will be taught through lectures. Step 3 (educational participation or self-confidence): Increase self-esteem and self-control through educational participation by transferring educational materials in group discussion sessions from patient to active family member. Step 4 (Evaluation): Evaluate the process to evaluate the model steps before the start of each session with questions and answers about issues During this period, the researcher will contact patients and caregivers by phone to answer problems. Before and after the intervention, Zarit questionnaire to measure care pressure and Connor and Davidson will be used to assess resilience.
Category
Behavior
2
Description
Control group: In the control group, the patient and family will receive individual training by hemodialysis staff. Before and after the regular training, the care and resilience questionnaire section will be completed by the patient's family. In terms of ethical issues after the research, during a 2-hour session, all educational issues will be taught to patients in the control group and the main caregiver of the family to refer to the dialysis ward and educational materials will be provided to them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Farnaz Kiani
Street address
naghlieh Street
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
ihosp@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vice President for Research
Street address
Najafabad, University Blvd., Islamic Azad University, Najafabad Branch
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
INFO @ IAUN.AC.IR
Web page address
https://iaun.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farnaz kiani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Elahieh Town - Kashani St. - Alley 12 - Baharestan Complex - Unit 7
City
Kermanshah
Province
Kermanshah
Postal code
6719934986
Phone
+98 83 3843 3755
Email
kiani.farnaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh salmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan, Najafabad, University Blvd.
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2207
Email
f-salmani@pnu.iaun.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farnaz Kiani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Elahieh Town - Kashani St. - Alley 12 - Baharestan Complex - Unit 7
City
kermanshah
Province
Kermanshah
Postal code
6719934986
Phone
+98 83 3843 3755
Email
kiani.farnaz@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After people are not identified, part of the data is shared, such as information about the main consequences.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Academic researchers and scientific institutes
Under which criteria data/document could be used
In order to conduct scientific research in the field of research, unidentifiable personal data will be made available to academic researchers and scientific institutes.
From where data/document is obtainable
They can contact us at kiani.farnaz@yahoo.com to receive information.
What processes are involved for a request to access data/document
After reviewing and confirming the accuracy of the information, the researcher requesting the information will be provided to them.