This research is a clinical trial which was done on 50 family caregivers of elderly patients with dementia who had referred to Shariati psychiatric clinic & Modarres hospital of Isfahan city. Caregivers were selected with convenient sampling then randomized to experimental & control groups. The main inclusion criteria were being main family caregiver, having age of above 21 years and education level of above elementary. Caregivers of experimental group participated in a family education program but caregivers of control group didn’t participate in this program. This program was based on a booklet codified by researcher. The purpose of this study was determining & comparing caregiver burden before, immediately & one month after execution of family education program in intervention & control group & between groups. The data were collected by Zarit caregiver burden scale which completed by caregivers of both groups before, after & one month after executing family education program. Also Mini Mental Status Examination was used for old adults before execution of the program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809302200N2
Registration date:2010-03-18, 1388/12/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-18, 1388/12/27
Registrant information
Name
Saeid Pahlavanzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1772 7861
Email address
pahlavanzadeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Isfahan university of medical sciences
Expected recruitment start date
2009-04-09, 1388/01/20
Expected recruitment end date
2009-07-11, 1388/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family education program on family caregivers' burden in elderly patients with dementia
Public title
The effect of family education program on families' burden in elderly patients with dementia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: family caregiver knows yourself as main caregiver of patient, age of caregiver is above 21 years, he or she would have education level above elementary, she or he would be as main caregiver only for one patient with chronic condition (with dementia), she or he didn’t participate in family education meetings about care of elderly before, other caregivers (such as private nurses) didn’t help for caring of patient. Exclusion criteria: caregiver would participate in less than 4 education meetings, patient would pass away during study, caregiver has acute or chronic physical & mental diseases which obstruct patient care, caregiver would use psychotropic drugs, caregiver abandon care of elderly to long term care centers during one month after intervention
Age
To 91 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Vice chancellor for research of Isfahan university of medical sciences
Street address
Hezarjarib street
City
Isfahan
Postal code
8174673461
Approval date
2010-01-13, 1388/10/23
Ethics committee reference number
387407
Health conditions studied
1
Description of health condition studied
Dementia
ICD-10 code
F00, F01,
ICD-10 code description
Dementia
Primary outcomes
1
Description
Reduction of caregiving burden
Timepoint
5 weeks after intervention
Method of measurement
caregiving burden index
Secondary outcomes
empty
Intervention groups
1
Description
Family education program about care of elderly
Category
Other
2
Description
No intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital & Shariati psychiatric clinic
Full name of responsible person
Fatemeh Ghaedi Heidari
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan university of medical sciences
Full name of responsible person
Peyman Adibi
Street address
Hezarjarib street
City
Isfahan
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 Isfahan 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
Isfahan university of medical sciences
Full name of responsible person
Jahangir Maghsoudi
Position
MS of psychiatric nursing
Other areas of specialty/work
Street address
No.95, Poorsina alley, Beheshti st.
City
Isfahan
Postal code
8184685651
Phone
+98 31 1234 9963
Fax
+98 31 1669 9398
Email
maghsoudi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Saeid Pahlavanzadeh
Position
MS of psychiatric nursing
Other areas of specialty/work
Street address
No. 12, Sadra building, Mehr alley, Khayam st.
City
Isfahan
Postal code
8185676391
Phone
+98 31 1772 7861
Fax
+98 31 1669 9398
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Zahra Ghazavi
Position
MS of psychiatric nursing
Other areas of specialty/work
Street address
2nd apartment, Amini negad st., Char bagh bala st.
City
Isfahan
Postal code
8163613391
Phone
+98 31 1666 4234
Fax
+98 31 1669 9398
Email
zahra_ghazavi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)