The aim of this study is to determine the effect of care centered group discussion and workshops on the caregiver burden of patients undergoing hemodialysis. This study is a randomized clinical trial. Participant of this study contain 105 caregivers of patients undergoing hemodialysis in educational therapeutic centers in Urmia. They are their family member and they have primary responsibility of patient care at home. Caregivers are selected and allocated randomly in three groups of intervention (group discussion and workshops) and control groups. Demographic and caregiver burden questionnaire will be completed by caregiver before the intervention. The program consist of 6 sessions of group discussion (2 hour) and 4 sessions of workshops (4 hour) during 6 weeks. Topics of the program include learning about end stage renal disease, principle of self care, personal health, role planing and delegating tasks, promote of care skills, ways of increase confidence, reduce stress, time management, education to increase communication skills with friends and acquaintances. Those who don’t attend in two training sessions will be excluded. One week after the intervention the caregiver burden questionnaire will be completed by caregivers in intervention and control groups. After intervention, educational booklet will be given to the control group. The data will be analyzed using descriptive and analytic statistics.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062823779N2
Registration date:2016-08-07, 1395/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-07, 1395/05/17
Registrant information
Name
Mehdi Torabi
Name of organization / entity
Urmia University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3682 4179
Email address
torabi.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences and Health Services
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of care centered group discussion and workshops on the caregiver burden of patients undergoing hemodialysis
Public title
Comparison the effect of care centered group discussion and workshops on the caregiver burden
Purpose
Supportive
Inclusion/Exclusion criteria
Include criteria: Age between 18-60 years; Can read and right; Lack of mental illness and chronic physical and cognitive disorders, hearing and vision; Lack of use drugs and psychotropic substances; The care of patients have at least 6 months; Is not a member of the medical team; With the patient in one place to live; Are main caregivers; Orientation to Persian language; Access to cell phone or telephone; Be able to participate in training sessions; Don’t Participate in other educational classes.
Exclude criteria: Don’t attend two training sessions; Death of the patient in during of this study; Don’t want to attend classes.
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:
105
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
Urmia University of Medical Sciences and Health Services
Street address
Emergency district, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Approval date
2015-09-09, 1394/06/18
Ethics committee reference number
ir.umsu.rec.1394.184
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
burnout severity
Timepoint
before intervention and 1 week after intervention
Method of measurement
Zarit caregiver burden scale
Secondary outcomes
empty
Intervention groups
1
Description
Group discussion:
This program consist of 6 sessions of group discussion (2 hour) during 6 weeks. To facilitate the work, as well as increase performance classes, their intervention groups will be divided into smaller groups. So that the group discussion divided into third groups. The topics of the program include learning more about end stage renal disease, principle of self care, personal health, role planning and delegating tasks, promote of care skills, ways of increase confidence, reduce stress, time management, education to increase communication skills with friends and acquaintances.
Category
Behavior
2
Description
Workshops:
This program consist of 4 sessions of workshops (4 hour) during 4 weeks To facilitate the work, as well as increase performance classes, their intervention groups will be divided into smaller groups. So that workshop will be divided into 2 groups. The topics of the program include learning more about end stage renal disease, principle of self care, personal health, role planning and delegating tasks, promote of care skills, ways of increase confidence, reduce stress, time management, education to increase communication skills with friends and acquaintances.
Category
Behavior
3
Description
Control group:
Routine training will be conducted in the control group. After intervention, educational booklet will be given to the control group.