Stroke is a stressful event which brings about various physical, psychological, social and economic problems that affect different aspects of the patient's life. Therefore, this study is conducted to investigate the impact of a self-efficacy program on self-care ability of patients with stroke. This study is conducted as a clinical trial which includes two group and three stages with a test plan before, immediately after and one month after stroke occurrence. 50 patients with stroke, who are hospitalized in the neurology department of Kashani Hospital in Isfahan city, are selected by the simple continuous method and are placed randomly in two groups of test and control. Patients of the test group are divided into 5 groups of 5 people and the self-efficacy program is implemented for them in 6 sessions. Then, Barthel questionnaire is completed for both groups before and after the intervention and one month after the intervention and the results are analyzed statistically by using descriptive and inferential statistics and software of SPSS version 18.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041733481N1
Registration date:2017-06-09, 1396/03/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-09, 1396/03/19
Registrant information
Name
Zahra Rafiee
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 420 7290
Email address
zahra.rafiee@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of self-efficacy on self-care ability of patients with stroke: a clinical trial study
Public title
The impact of self-efficacy on self-care ability of patients with stroke: a clinical trial study
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The occurrence of stroke for the first time; willingness to participate in the study; aged between 50 and 70 years; lack of addiction to alcohol and drugs; lack of simultaneous participation in another study; no loss of consciousness level; capable of responding to questions and getting scores more than 23 from the Mini-Mental State Exam; having self-care ability and earn scores above 50 from Barthel index; having at least literacy to read and write; the ability to understand conversation in Farsi and lack of malignant physical illness.
Exclusion criteria: The absence of more than 2 times in meetings; not wanting to continue the intervention; the incidence of new diseases that cause more disability in these patients.
Age
From 50 years old to 70 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
50 qualified patients are divided into two equal case and control groups with Sealed envelope method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan
City
Isfahan
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.MUI.REC.1395.3.783
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I69.4
ICD-10 code description
Sequelae of stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
self-care ability
Timepoint
before, immediately after and one after clinical trial
Method of measurement
Barthel questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: includes 6 seasons with aim of introduction, improvement of patient's independency, improvement of self-esteem and introduction to use problem solution technique
Category
Lifestyle
2
Description
Control group: pharmacotherapy and 2 educational seasons about the disease, side-effects of it and consumed medicines
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology department of Kashani hospital
Full name of responsible person
Ali Mohammadi
Street address
Hezar Jerib St, Isfahan University of Medical Sciences, Isfahan, Iran
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
Mehdi Nemat Bakhsh
Street address
HezarJerib St, Isfahan University of Medical Sciences
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
Faculty of Nursing and Midwifery
Full name of responsible person
Ali Mohammadi
Position
PHD
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2917
Fax
Email
alimohammadi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Ali Mohammadi
Position
PHD
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2917
Fax
Email
alimohammadi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Ali Mohammadi
Position
PHD
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2917
Fax
Email
alimohammadi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)