This randomized clinical trial tested the effectiveness of supportive educative group intervention in decreasing HF family caregiver's burden of caregiving
This intervention consisted of four weekly, two- hour multi media training session that included education and family support for family caregiversin intervention group. Control group will recive routine care. Family caregiver burden will be assessed at preintervention,after intervention and 3-month after intervention using the Zarit Burden Interview. To determining of intervention effect over 3-month period between and inter-gruops, parametric and nonparametric statisticall tests will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021212452N1
Registration date:2013-03-18, 1391/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-18, 1391/12/28
Registrant information
Name
Shahram Etemadifar
Name of organization / entity
Isfahan University of Medical Sciences, Fculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2969
Email address
etemadifar@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Isfahan University of Medical Sciences
Expected recruitment start date
2012-12-07, 1391/09/17
Expected recruitment end date
2013-03-07, 1391/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectivness of a supportive educative group intervention on family caregiver burden of patients with heart failure
Public title
Designing and Implementation of Interventional Program Based On
Family Caregiver Needs of Congestive Heart Failure Patients: A Mixed
Methods Study
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: Having 18 years old; Being a main and family caregiver; Having several month experiences in caregiving; Financially supports the patient; having good comunication skill
exclusion criteria: Sever physical and mental disorder; Unwillingness in ongoing participation
Age
From 18 years old to 80 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)
Single 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 the Isfahan University of Medical Sciences
Street address
Research Dupty of Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran.
City
Isfahan
Postal code
8174673461
Approval date
2012-06-24, 1391/04/04
Ethics committee reference number
391084
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure
Primary outcomes
1
Description
family caregiver burden
Timepoint
preintervention, Immediately after intervention, 3-month after intervention
Method of measurement
zarit burden interview scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention for intervention group: The supportive educatiive group intervention program consisted of four weekly, two hour multimedia training sessions that included education, family support and held during four consecutive weeks. Four supportive educative groups of ten family caregivers were arranged with the same content, and the interventional program was conducted by a team consist of cardiologist, psychiatric nurse, cardiac nurse and clergy man in intervention group
Category
Other
2
Description
intervention for control group: This group will be recieved routine of hospital
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical and Training Hospital of Isfahan University of Medical Sciences
Full name of responsible person
Mrs. Zarin Tansaz
Street address
Patient and Family Education Center of Alzahra Hospital of Isfahan University of Medical Sciences, Sofe Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr peyman Adibi
Street address
Research Dupty of Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Grant name
فصل دوم برنامه تحقیقات دانشگاهی
Grant code / Reference number
1191-10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences
Full name of responsible person
Masoud Bahrami
Position
Assossiate profossor, A faculty Member of Nursing and Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2926
Fax
Email
bahrami@mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences
Full name of responsible person
Shahram Etemadifar
Position
Phd candidate in nursing,Msc in nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjereeb Street, Isfahan, Iran
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2969
Fax
Email
etemadifar@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)