The purpose of this study is to determine the effect of supportive educative program on caregiver’s burden and quality of life in hemodialysis patients. This study is a randomized clinical trial. The members of this research are 76 people of caregivers of patients under hemodialysis in Hashemi Nejad Educational Treatment Center that they are a member of patient’s family and have the primary responsibility for care of patient at home and if they be absent in one of the training sessions, they will be excluded from study. Based on reference day, for the patient’s hemodialysis in one and couple days, caregivers randomly will be placed in intervention and control groups. Then Demographic, Caregiver’s burden (CBI) and Quality of life (SF-36) questionnaires are completed before conducting the research by caregivers. This Program includes 6 sessions for 1 hour during two weeks that the care method in home of hemodialysis patient during 2 sessions and problem-oriented coping skills during 4 sessions are trained by lecture, role playing, group discussion, question & answer with using slides and booklets to intervention group. 6 Week’s after intervention, the caregiver’s burden (CBI) and quality of life (SF-36) questionnaires will be completed by intervention and control group. And after intervention, to comply with ethical issues, Training booklet and Educational Content will be given to control group, then the information of questionnaires will be analyzed by statistical and descriptive tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809032769N1
Registration date:2015-05-30, 1394/03/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-05-30, 1394/03/09
Registrant information
Name
Mansoureh Ashghaly Farahani
Name of organization / entity
Iran University Medical Sciences ,Nursing & Miwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1615
Email address
farahani.ma@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Reaserch Assistance of Iran University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Supportive Educative Program on Caregiver’s Burden and Quality of life in Hemodialysis patients
Public title
Supportive Educative Program on Caregiver’s in Hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for patients:
1- Age 18 to 65 years old with hemodialysis program per week (three times per week and each time, 3-4 hours).
2- Have a primary caregiver at home.
3- No previous history of renal transplant.
Inclusion criteria for caregivers:
1- caregivers should have the primary responsibility to care of the patient and should be a member of family.
2- Age more than 18 years old.
3- Have the ability to speak, read and write in farsi.
4- Do not any known mental or neurological disorder.
5-Caregivers should not be a member of medical staff.
The exclusion criteria:
1-Occurrence of stressful events in family ( divorce, financial crisis, death of the primary family members).
2-Participating in training courses related with research intervention program during the study.
3- The lack of willingness to continue participating during the study.
4-The absence of primary caregiver who receipts training even in one training session.
5-The patient should be a candidate for kidney transplant during the study.
6-Protecting other chronic patients except hemodialysis patient in the family.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Caregivers in this study randomly will be placed in intervention and control groups Based on reference days, for the patient’s hemodialysis in one and couple.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Between The Highway Martyr Chamran and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway ,Tehran, Iran.
City
Tehran
Postal code
1997613883
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
93/ D/ 105/ 6175
Health conditions studied
1
Description of health condition studied
Hemodialysis - Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
caregiver’s Burden
Timepoint
Pre test and Six Week’s after intervention
Method of measurement
Caregiver’s Burden index
2
Description
Caregiver’s Quality of life
Timepoint
Pre test and Six Week’s after intervention
Method of measurement
Quality of life sf-36
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the intervention program consisted of 6 sessions training on how to care hemodialysis patient and problem-oriented coping skills (Communicating correctly, anger management, deep breathing) for adapting to the role of caregivers that will be divided into two separate parts and intervention program will be starts follows; first the learning part of how to care patients with hemodialysis at home will be trained during first two session and then the training part of problem-oriented skills will be conducted during four next sessions, Each session will be one hour during two weeks with lecture, role playing, group discussion, Questions and answers by using slide and training booklet. The prepared training booklet in first session of training program will be given to the caregivers and it will be emphasized to study the issues of each session at home. During sessions, the researcher will encourage the caregivers to Q and A and group discussion about the questions and ambiguities. At the end of each session, the conclusion will be summarized by participants. Also, The Caregivers will be asked to exercise and repeat these skills at home. And during sessions, they should exercise the anger management and deep breathing skills as role playing in class. Also The Telephone number of researcher will be given to caregivers for solving the problems and answer to questions.
In the first session, the researcher after its introduction, divides the caregivers into 5-8 people groups and then will be express the training program, the aim of the intervention and the importance of cooperation, Also the comments about end stage renal disease, its signs and symptoms, causes and treatments and the importance of hemodialysis will be given to patients. In the second session, care training at home about how to conduct and control the special activities such as patient transmission, providing personalized patient care (bathing, hygiene, clothing, physical activity, diet and medication, weight control and blood pressure and fistulas treatment) and adjusting the hemodialysis session and monitoring the patient’s condition will be explained. Also, the problems and experiences of caregivers will be examined by group discussion. In third session, the importance of caregiver role and his/her adjustment with this role will be discussed and we will discuss about the compatibility problems conducted for caregivers. And in fourth session, issues about problem-oriented coping skills to properly communicate will be presented. And in the fifth and sixth sessions, will discussed about the warning signs of anger, the creator and resonator situation, how to control anger.
Category
Other
2
Description
For control group, the training will not give by researcher and routine approaches of educational Hashemi Nejad Medical Centers will be given to them that include educational pamphlets.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi Nejad Educative Treatment Center
Full name of responsible person
Mansooreh Ashghali Farahani
Street address
Iran School of Nursing and Midwifery,Yasami St., Vali Asr Avenue.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistance of Iran University of Medical Sciences
Full name of responsible person
Syed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, Between The Highway Martyr Chamran and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway ,Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance of 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
Iran School of Nursing and Midwifery, Iran Universityof Medical Science
Full name of responsible person
Mansoore Ashghali Farahani
Position
Asistant Knowledge
Other areas of specialty/work
Street address
Iran School of Nursing and Midwifery , Yasami St., Vali asr Avenue.
City
Tehran
Postal code
1997613883
Phone
+98 21 8888 2885
Fax
Email
m_negar@yahoo.com ؛ Farahani.ma@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran School of Nursing and Midwifery, Iran University of Medical Science
Full name of responsible person
Mansooreh Ashghali Farahani
Position
Assistant Knowledge
Other areas of specialty/work
Street address
Iran School of Nursing and Midwifery , Yasami St., Vali asr Avenue .
City
Tehran
Postal code
1997613883
Phone
+98 21 8888 2885
Fax
Email
m_negar@yahoo.com ؛ Farahani.ma@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran School of Nursing and Midwifery, Iran Universityof Medical Science
Full name of responsible person
Golnar ghane
Position
M.Sc. Nursing Student
Other areas of specialty/work
Street address
Iran School of Nursing and Midwifery , Yasami St., Vali asr Avenue
City
Tehran
Postal code
1997613883
Phone
+98 21 8888 2885
Fax
Email
golnarghane@gmail.com ؛ goli396@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)