The purpose of this quasi experimental study is the empowering of the stroke patients’ caregiver behaviors. The intervention phase will be 2 months. Eighty eight caregivers will be selected by convenience sampling. The first 44 caregivers in the experimental group and next 44 caregivers will be inserted in the control group. The study begins with a pretest. The control group does not receive any intervention. The intervention will be included the educational sessions on family-centered empowerment model with these steps: 1- Increasing the perceived threat (the experimental members’ perceived sensitivity and severity of the problems will be raised during two 45-minute group discussion sessions). 2-Problem solving (caregivers become practically familiar with the problem and its solving process during two 45-minute group discussion sessions). 3- Educational partnership (the participant will be transferred educational matters to another patient’s family member via the developed pamphlets and a booklet). 4- Process evaluation will be done with oral questions at the beginning and end of each session and a final evaluation is conducted with a post-test. Inclusion criteria: Living with a stroke patient who has motor impairment (hemiplegia, and quadriplegia); age between 15 and 65 years old; caregivers should be literate and be intended to cooperate in the study. Exclusion criteria: Unable to continue in the study for any reason. Outcome measures include empowerment of the stroke patients' caregivers in their knowledge, perceived threat (sensitivity and severity), self-efficacy, self-esteem and performance.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012082810679N1
Registration date:2013-01-25, 1391/11/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-25, 1391/11/06
Registrant information
Name
Akram Kheirollahi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
a.kheirollahi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-12-15, 1391/09/25
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the empowerment of the stroke patients’ caregivers educated based on the family-centered empowerment model with the control group
Public title
Empowerment of the stroke patients’ caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Living with a patient by stroke who has motor impairment (hemiplegia, and quadriplegia); 15-65 years old; caregivers should be literate and be intended to cooperate in the study. Exclusion criteria: unable to continue the study for any reason.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Hamadan University of Medical Sciences’ Ethics Committee
Street address
Fahmideh St., University of Medical Sciences, Hamadan
City
Hamadan
Postal code
8698365178
Approval date
2012-08-18, 1391/05/28
Ethics committee reference number
1839/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Cerebral vascular accident
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
The level of the CVA caregivers' self-efficacy
Timepoint
Before intervention and 1 month after intervention.
Method of measurement
The CVA caregivers' self-efficacy questionnaire.
2
Description
The level of the CVA caregivers' sensitivity to perceived threats
Timepoint
Before intervention and 1 month after intervention.
Method of measurement
The CVA caregivers' sensitivity to perceived threats questionnaire .
3
Description
The level of the CVA caregivers' severity of the perceived threat
Timepoint
Before intervention and 1 month after intervention.
Method of measurement
The CVA caregivers' severity of the perceived threat questionnaire.
4
Description
The level of the CVA caregivers' knowledge
Timepoint
Before intervention and 1 month after intervention.
Method of measurement
The CVA caregivers' knowledge questionnaire.
5
Description
The level of the CVA caregivers' self- esteem
Timepoint
Before intervention and 1 month after intervention.
Method of measurement
Rosenberg self-esteem questionnaire
6
Description
The level of the CVA caregivers' performance
Timepoint
Before intervention and 1 month after intervention.
Method of measurement
The CVA caregivers' performance form (based on the daily self report).
Secondary outcomes
empty
Intervention groups
1
Description
The education will be implemented based on the family-centered empowerment model steps as follows: 1- the first step is to increase the participants’ perceived threat (severity and susceptibility). The perceived severity means to understand the risk of the absence of proper caring behavior and the perceived susceptibility means to comprehend how a person is at risk for the diseases resulting from lack of proper caring behavior. Thus, by holding two group discussions and question and answer of participants about right and wrong caring behavior and unhealthy behaviors that will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). 2- the second step is problem solving. Problem solving will be conducted via group discussions in a manner that promotes the participants' self-esteem. The goal of this step is understanding the problems by caregivers and providing their solutions. The problem-solving sessions will hold in two 45-minute small group discussions under supervision of the researcher. In these sessions, some objective examples of their problems with the caring behaviors will be presented. Then, the researcher conducts the group-discussion and let them them to modify their wrong caring behaviors. At this stage, the caregivers get practically familiar with their problems and their solving process. This issue will enhance their self-efficacy. 3- the third step is participation in the training. In this step, the participants transfer the discussed topics in the previous meetings by the pamphlets and a booklet to another active member of the family (according to the caregiver option). 4- the fourth step is evaluation. It includes two stages, process evaluation and final evaluation.
Category
Behavior
2
Description
No intervention in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Educational and Medical Center
Full name of responsible person
Street address
Mirzadeheshghi St. Farshchian Educational and Medical Center
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences, Vice chancellor for Research.
Full name of responsible person
Dr. Heydar Tavilani
Street address
Fahmideh St., Hamadan University of Medical Sciences, Vice chancellor for Research
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences, Vice chancellor for Research.
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
Hamadan University of Medical Sciences
Full name of responsible person
Akram Kheirollahi
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Fahmideh St., Hamadan University of Medical Sciences