This semii-experimental study is a pre-test and post-test design.The study population was all carers of hemodialysis patients referring to Imam Khomeini Hospital Khomein. Convenient sampling was done. At the time of entering the study, caregivers' maturity is based on the Barthel's assessment of the patients under their care, then the caregivers of patients in five blocks (24- 0 with complete dependence, 25-49 with severe dependence, 50- 74 with moderate dependence, 75-89 with mild affiliation and 99-90 with very low dependence and 100 indicating non-dependence). Then, the subjects of each block are randomly assigned to two groups of test and control. The caregivers of the two groups completed the questionnaires before the intervention and then the intervention group received 5 training sessions for the study purposes. . These trainings include anxiety and depression control programs, fatigue elimination, elimination of physical health problems, relief and relief concerns, and eliminating the guilt and fault of the caregiver in order to prevent relapse due to care problems. The Patient Care Instruction Book is also provided to them. For the final evaluation, the test group again completed the perceived severity questionnaire four weeks after the last session of empowerment. The control group also completed the questionnaire four weeks after completing the questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082725843N3
Registration date:2017-08-28, 1396/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-28, 1396/06/06
Registrant information
Name
Hajar Sadeghi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
haj.sadeghi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Khomein University of Medical Sciences
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2017-08-02, 1396/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment intervention on perceived severity of threat in caregivers of patients with hemodialysis
Public title
The effect of family-centered empowerment intervention on perceived severity of threat in caregivers of patients with hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; physical and mental ability to take care of the patient; caring for a hemodialysis patient who has been hemodialized over the past 6 weeks; 18 years old care givers or older; have literacy to read and write; care givers can speak Persian.
Exclusion criteria: unwillingness of research or a member of his family to cooperate at every stage of research; patient or care givers hospitalization; physical or mental problems that lead to disability at any stage of the research.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Science, Saculty of nursing and midwifery, Sardasht, Arak
City
Arak
Postal code
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.ARAKMU.REC.1395.427
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Hemodialysis
Primary outcomes
1
Description
Severity of perceived threat in caregivers
Timepoint
Before and 4 weeks after intervention
Method of measurement
Modified Barthel Index and severity of perceived threat questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group participates in 5 sessions of two-hour training to empower caregivers in family-based care by improving the level of knowledge and awareness of caregivers, about the process of illness and the severity of the complications and the process of treatment, and how to ensure proper care of the patient and adapt to the role of care. . This empowerment is a collection of information, behaviors and practices that are based on the needs of caregivers to reduce and prevent the complications and risks of the disease on the self-care taker, including anxiety and depression control programs, fatigue removal, fixing Careful physical problems, relieve troubles and concerns about recurrence of the disease, and eliminate the feeling of guilt and fault in the caregiver that the disease has not been relapsed due to care problems. Then carers begin to discuss their issues based on their experiences and the researcher has a supportive, guidance and educational background. At the end of each session, after the discussions are finalized, their questions will be answered, and the date and purpose of the next meeting will be determined next week, as well as a handbook on patient care education.
Category
Other
2
Description
Control group: Control group receive routine cares.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Khomein
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Khomein University of Medical Sciences
Full name of responsible person
Hajar Sadeghi
Street address
Saculty of nursing, next to health center, Qods Blvd.
City
Khomein
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Khomein 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
Khomein University of Medical Science
Full name of responsible person
Hajar Sadeghi
Position
MSc
Other areas of specialty/work
Street address
Saculty of nursing, next to health center, Qods Blvd.
City
Khomein
Postal code
Phone
+98 86 4622 1533
Fax
Email
haj.sadeghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomein University of Medical Science
Full name of responsible person
Hajar Sadeghi
Position
MSc
Other areas of specialty/work
Street address
Saculty of nursing, next to health center, Qods Blvd.
City
Khomein
Postal code
Phone
+98 86 4622 1533
Fax
Email
haj.sadeghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Khomein University of Medical Science
Full name of responsible person
Hajar Sadeghi
Position
MSc
Other areas of specialty/work
Street address
Saculty of nursing, next to health center, Qods Blvd.
City
Khomein
Postal code
Phone
+98 86 4622 1533
Fax
Email
haj.sadeghi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)