The effect of a program based on family-centered empowerment model on perceived threats and care burden in family carers of spinal cord injured patients
Determining the impact of a program based on a family-centered empowerment model on perceived threats and care burden in family carers of spinal cord injured patients referring to the Spinal Cord Injury Society of Isfahan Selected Centers of the University of Medical Sciences in 2018
Design
A three stage clinical trial with an intervention group and a control group, and 35 patients in each group
Settings and conduct
A study is conducted at the Isfahan Spinal Cord Injury Association and the Tavana Rehabilitation and Training Center for the Spinal Cord Injury in Shahre-kord. After implementation of the empowerment program on caregivers of patients in four stages, evaluation is performed one and three months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the caregiver is required to be between 18-60 years old; have taken care of a patient with spinal cord injury for at least 6 months; have reading and writing skills in the caregiver
Non-inclusion criteria: The caregiver suffers from any acute or chronic physical disorders and psychological disorders; Membership of the caregiver in the health care team
Intervention groups
Intervention group: In this group, the family-centered empowerment program is four-step. Step 1: Perceived threats that is include perceived severity and perceived sensitivity. Step Two: This step is about improving self-efficacy in which caregivers is trained their skills in practice. Step Three: This step is to increase self esteem or self confidence through educational participation. Step Four: Includes process evaluation and final evaluation. Control group: This group receive the same training as the intervention group in a general, in summary and in two sessions. The evaluation of this group will be one and three months after the intervention, as in the intervention group.
Main outcome variables
Severity of perceived threat; burden of care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037895N3
Registration date:2019-06-04, 1398/03/14
Registration timing:registered_while_recruiting
Last update:2019-06-04, 1398/03/14
Update count:0
Registration date
2019-06-04, 1398/03/14
Registrant information
Name
Mohsen Torabi Khah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3071
Email address
m.torabikhah@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a program based on family-centered empowerment model on perceived threats and care burden in family carers of spinal cord injured patients
Public title
The impact of empowerment on perceived threat and care burden in caregivers of spinal cord injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The caregiver is required to be at least 18 and maximally 60 years old
Have directly and actively taken care of a patient with spinal cord injury for at least 6 months and deserve to make decisions concerning the treatment of the injured person
Have obtained the informed written consent for participation in the research
Have no hearing or vision impairment for participation in the training sessions for caregiver
Have reading literacy for caregiver
Have no mental disorders or chronic physical illness and also have no history of taking medication and psychoactive substances for caregiver
Have no history of participation in any training session or any research related to the subject of this study for caregiver
Living the caregiver with a patient suffering from injured spinal cord injury
Have obtained a Barthel Index (King's version) score less than and equal to 90 in Injured
Exclusion criteria:
Having other acute or chronic physical disorders and psychological disorders in the caregiver
Caregiver membership in the healthcare team
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Among the injured and the caregivers who meet the inclusion criteria of the study, the caregiver is asked to randomly pick one of the two balls from the bag. People who pick the Ball 1 will be put into the intervention group and those who take the number 2 will be allocated to the control group
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 Isfahan University of Medical Sciences
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.490
Health conditions studied
1
Description of health condition studied
Spinal cord injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Severity of perceived threat
Timepoint
One and three months after the intervention
Method of measurement
Questionnaire
2
Description
Burden of care
Timepoint
One and three months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the family-centered empowerment program is implemented through four steps. Step 1: the Perceived threats including perceived severity and perceived sensitivity. In perceived severity, related to the complications and risks of the disease, a questionnaire, having 14 questions and Likert responses will be used. Based on the results of this survey, for the five most common issues, five one-hour training sessions, along with discussion will be held in the group. Each group includes 9 people. Before the start of the first session, an examination on the provided care amount and the threat perceived by caregivers will be taken to compare the grades obtained in one and three months after the implementation of the family-centered empowerment program. In this section, the concepts are also provided to caregivers through pamphlets and booklets. For perceived sensitivity, a questionnaire having 14 questions, along with Likert responses will be used. At this part, in three one-hour sessions, the management of the anxiety, depression and the stress associated with the care of the patients injured in his/her spinal cord will be taught in group. The concepts in this section are also given to caregivers in using pamphlets and booklets. Step Two: This step is on improving self-efficacy through which caregivers are trained with practical skills. In a group session, and via problem solving method, caregivers' problems will be identified and prioritized, then solutions will be discussed by themselves. Each skill will then be taught in a practical way and will be taught taking self-efficacy steps. In three one-hour sessions, caregivers are provided with the method/s of controlling vital signs, physiotherapy of limbs and Kegel and Crede's exercises. The concepts in this section are also provided to caregivers through pamphlets and booklets. Step Three: This step is to increase self-esteem or self-confidence through educational participation. At this stage, caregivers are asked to convey the materials acquired through group discussion, as well as the lessons learnt on self-efficacy, into their own patients. Training cards, containing the materials presented in each session, will also be given to family caregivers to deliver to their patients. In case questions or problems raise, caregivers will write down the related questions and submit them or those of their patients to the nurses in the next sessions attending the center of the spinal cord injury. Given that patients may not be empowered through the training provided to family caregivers and studying the training cards, in order to discuss the materials provided by the family caregivers and what the patients have been learnt using the card, they and their family caregivers are invited to the center. Step Four: It includes process evaluation and the final assessment. To evaluate the process, at the beginning of each session, caregivers are asked to verbally respond to 5 questions on the concepts contained in the training session on the day the session held. The answers to this section will be compared at the end of the session. For the final evaluation, a written test will be carried out by the caregivers who will calculate the score of the care amount and perceived threat within one and three months after the intervention.
Category
Other
2
Description
Control group: The same materials, i.e., the whole materials and their summary, are given to this group (like those provided for the intervention group) in two sessions. This group, as the same as the intervention group, will be evaluated at one and three months after the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Rehabilitation Center for Injured Spinal Cord Injury
Full name of responsible person
Fatemeh Karami-Zadeh
Street address
Sadi
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815893119
Phone
+98 38 3334 6522
Email
tavana.rehabilitation@gmail.com
2
Recruitment center
Name of recruitment center
Isfahan Spinal Cord Association
Full name of responsible person
Mahmoud Naghib-Zadeh
Street address
Atashgah
City
Isfahan
Province
Isfehan
Postal code
8188753664
Phone
+98 31 3766 0175
Email
info@scisf.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghaegh Haghjooe Javanmard
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673466
Phone
+98 31 3792 7533
Email
sh-haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Taheri Ghale-Salim
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
a.taheri@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
َAhmad Taheri Ghale-salim
Position
Student of MSc in Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
a.taheri@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Hojatollah Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
yousefi@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available