Determination of the effect of empowerment based on family-centered model on quality of life in patients with cerebral stroke
Design
A clinical trial, with a control group, with a parallel group, a unilateral blind, randomized using a random number table, and 100 participants.
Settings and conduct
The caregivers of the patients in the intervention group receive the necessary training during eight sessions in the hospital meeting room and then the patients’ quality of life is evaluated at one-month and two-month intervals and compared with the control group.
Participants/Inclusion and exclusion criteria
The study population consists of all patients with stroke and their families in Kashan, whose diagnosis has been confirmed by a neurologist and have a file in Shahid Beheshti Hospital.
Intervention groups
Patient caregivers in the intervention group receive the necessary training on their patient care during 8 training sessions. Care givers of the control group patients are not received any training during the study. After completion of the study, they will receive all necessary training.
Main outcome variables
Managing the cost of caring for stroke patients and changing the quality of life of stroke patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190617043915N1
Registration date:2019-08-06, 1398/05/15
Registration timing:retrospective
Last update:2019-08-06, 1398/05/15
Update count:0
Registration date
2019-08-06, 1398/05/15
Registrant information
Name
Alireza Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4234 9285
Email address
a_amini1990@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
2019-05-20, 1398/02/30
Actual recruitment end date
2019-06-20, 1398/03/30
Trial completion date
2019-08-06, 1398/05/15
Scientific title
The effect of family-centered empowerment pattern on quality of life in stroke patient
Public title
The effect of family-centered empowerment pattern on quality of life in stroke patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
cerebral stroks Patients with definitive diagnosis of a physician.
Who has been suffering from stroke,for the first time.
It has at least one complication of stroke, such as motor disorder, speech impairment, swallowing disorder, visual impairment, and urinary and fecal dysfunction.
Exclusion criteria:
Dissatisfaction to association in study.
Patients death.
It has more than once stroke.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by simple and individual method using random number table. The table numbers were used downward. Even numbers were considered for intervention group and odd numbers for control group. Hiding was done by using opaque sealed envelopes with a random sequence. Each of the random sequences is registered on a card, then the cards are inserted into the envelopes, the envelopes are sealed and packed in the boxes. At the time of registration, one of the envelopes is opened in accordance with the order of entry of eligible participants to the study and then the group assigned to that participant is shown.
Blinding (investigator's opinion)
Single blinded
Blinding description
At the beginning of the study, participants are given the necessary explanations on how to do the task, but are not given any explanation as to which group they are in. At the end of the study, all training are provided to the control group as well.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ravandi Blvd,
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.37
Health conditions studied
1
Description of health condition studied
Quality of life for patients with stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Quality of life scores in the quality of life questionnaire for patients with stroke
Timepoint
Before the intervention, one and two months after receiving the training
Method of measurement
Quality of Life Questionnaire for Patients with Stroke
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Caregivers of patients with stroke who are in the intervention group receive eight sessions of patient care training and their patients' quality of life is measured at baseline, one month and two months later.
Category
Lifestyle
2
Description
Control group: The control group will not receive any training during the time the intervention group is being trained and after completing the third questionnaire (2 months after the study starts) all the training provided to the intervention group will be provided to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Alireza amini
Street address
Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
beheshtihospital@kaums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Alireza amini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
a_amini1990@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza amini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
a_amini1990@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza amini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
a_amini1990@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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