Comparison of the effect of health-promoting behaviors training in both caregiver-centered and patient-centered methods on the care burden of informal caregivers and adherence the treatment of patients undergoing hemodialysis
Determining and comparing the effect of health- promoting behaviors training in both caregiver- centered and patient- centered methods on the care burden of informal caregivers and following the treatment of patients undergoing hemodialysis
Design
A clinical trial with control group with a follow up period, parallel group, randomized, Blocking is used for randomization.
Settings and conduct
The teach back will be used to provide health promoting behaviors to the patient and care. the number of training Sessions is 7 sessions and three Separate Whats app groups will be formed to follow the intervention group. This study will be performed in selected hospital of Bushehr university of Medical Science and Bushehr Social security Organization.
Participants/Inclusion and exclusion criteria
have been on hemodialysis for at least 6 months / do not need temporary hemodialysis / patient must be over 18 years old and up to 70 years old / have the consent to participate in the study / be at least literate / have a smartphone / the patient has access to the internet / be responsible for the care of hemodialysis patient / be at least 18 years old.
the patient dies during the intervention / be known to have cognitive and mental disorder / one of the couple should not participate in the study / have serious physical problem while studying so that loses the ability to care for the patient / have known neurological disorders.
Intervention groups
the samples are then grouped into four group by random allocation(A,B,C,D). so that group A receives only patient centered training, group B receives only caregiver centered training. group c receives both patient and primary caregiver, patient centered and caregiver centered training. the control group D did not receive any training and only receive routine training from hemodialysis centers.
Main outcome variables
informal Caregiver burden, adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090522001930N4
Registration date:2021-11-12, 1400/08/21
Registration timing:prospective
Last update:2021-11-12, 1400/08/21
Update count:0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Hakimeh Vahedparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 8498
Email address
h.vahedparast@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of health-promoting behaviors training in both caregiver-centered and patient-centered methods on the care burden of informal caregivers and adherence the treatment of patients undergoing hemodialysis
Public title
the effect of health-promoting behaviors training in both caregiver-centered and patient-centered methods on the care burden of informal caregivers and adherence the treatment of patients undergoing hemodialysis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
have been on hemodialysis for at least 6 months
do not need temporary hemodialysis (poisoning- acute renal failure- guest)
patients must be over 18 years old and up to 70 years old
have the consent to participate in the study
be at least literate
have a smartphone
the patient has access to the internet
be responsible for the care of hemodialysis patients( based on self- declaration)
be at least 18 years old.
informal caregiver has access to the internet
Exclusion criteria:
the patient dies during the intervention
be known to have cognitive and mental disorder
one of the couples should not participate in the study
have serious physical problems while studying so that loses the ability to care for the patient.
give the person a break from continuing to work with the research team while studying.
have known neurological and mental disorder( based on the doctors diagnosis)
introduced caregiver the patient does not attend two or more sessions.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
248
Randomization (investigator's opinion)
Randomized
Randomization description
the samples( sick and caring couple) will be selected based on the purpose and considering the inclusion criteria and then will be assigned to 4 groups to match the groups by random block allocation. 15 blocks of 8 and one block 4 will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
the aim of this study was to determine and compare the effect of teaching health promoting behaviors in both caregiver centered and patient centered methods on the care burden of informal caregivers and adherence the treatment of hemodialysis patient referred to hemodialysis centers in bushehr and borazjan is planned in 2021. and samples are randomly assigned to four group(A,B,C,D). so that group A only patient participate in it and only patients receive patient centered education. in group B ,only caregivers participate and only caregiver receive caregiver centered education. group C include both the patient and primary caregiver couples, and participants in this group receive patient centered and caregiver centered training. and the control group D does not receive any training and only receives routine training of hemodialysis centers. this study is a randomized controlled trial with follow up. so that pre test will be taken from all 4 group and then immediately and 4 weeks(following) after the educational intervention , the questionnaires will be completed again by the samples participating in the study in all 4 group of interventional and control.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bushehr University of Medical Sciences
Street address
Pardis Site of Bushehr University of Medical of Science, Rishehr St, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2021-07-19, 1400/04/28
Ethics committee reference number
IR. BPUMS. REC. 1400. 070
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.6
ICD-10 code description
Long-standing and persistent renal disease with glomerular filtration rate (gfr) less than 15 ml/min.
Primary outcomes
1
Description
treatment adherence
Timepoint
pre- test before the intervention and immediately after the test and 4 weeks(following) after the intervention
Method of measurement
the end stage renal disease- adherence questionnaire developed by Youngmee Kim will be used.
Secondary outcomes
1
Description
caregiver burden
Timepoint
pre-test before the intervention and immediately after the test and 4 weeks(following) after the intervention
Method of measurement
A care burden questionnaire Guest and Novak with a 5 point Likert scale will be used.
Intervention groups
1
Description
Intervention group: Intervention A: only patients are included in this group, and initially by obtain a pre-test before the intervention and continue to holding training sessions using teach- back method for patients during 7 sessions and also create a whats app group to provide educational videos for patient and taking post- test immediately after intervention and one months later(following).
Category
N/A
2
Description
Intervention group: Intervention B: only caregivers are included in this group, and initially by obtain a pre-test before the intervention and continue to holding training sessions using teach- back method for primary caregiver during 7 sessions and also create a whats app group to provide educational videos for primary caregiver and taking post-test immediately after intervention and one months later(following).
Category
N/A
3
Description
Intervention group: Intervention C: in this group the patient and caregivers placed and initially by obtain a pre- test before the intervention and continue to holding training sessions using teach - back method for patient and their primary caregivers during 7 sessions and also create a common whats app group to provide educational videos for patient and their primary caregiver and taking post - test immediately after intervention and one months later(following).
Category
N/A
4
Description
Intervention group: Control group D: in the control group , no training is given to the patient and caregiver. It has a pre-test but not training sessions and whats app group formation and taking post-test immediately after intervention and one months later(following).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr University of Medical Science, Fatemeh Zahra Hospital
Full name of responsible person
Mehrdad Hayati
Street address
Moallem Square, Siraf Street, Bushehr.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0236
Email
mehrdadhayati1996@gmail.com
2
Recruitment center
Name of recruitment center
Salman Farsi Hospital
Full name of responsible person
Mehrdad Hayati
Street address
Salman Farsi Hospital( Social Security), Rishehr St, Bushehr.
City
Bushehr
Province
Boushehr
Postal code
7518759416
Phone
+98 77 3344 6640
Email
mehrdadhayati1996@gmail.com
3
Recruitment center
Name of recruitment center
Bushehr University of Medical Science, Hefdah Shahrivar Borazjan Hospital