Determining the effect of self-efficacy training on quality of life and self-efficacy of stroke patients
Design
This study is a clinical trial with control group. Among the stroke patients referred to Rafideh Rehabilitation Hospital, 80 available stroke patients based on inclusion criteria were selected and randomly assigned to two intervention and control groups.
Settings and conduct
This study is carried out at Rofeideh Hospital in Tehran. The study is done single blind in which patients won't know what intervention will be done for them.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients with confirmed ischemic stroke. People who have been stroke for more than 4 months and less than two years. Being aged 55 to 70 years; Conditions of failure: history of previous stroke
Intervention groups
The control group receives only routine hospital care and the intervention group, in addition to the 5 sessions of group training based on the self-efficacy model, participates for 90 minutes.
Main outcome variables
Quality of life score; self-efficacy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170619034625N1
Registration date:2018-08-17, 1397/05/26
Registration timing:prospective
Last update:2018-08-17, 1397/05/26
Update count:0
Registration date
2018-08-17, 1397/05/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0083
Email address
na.abolfathi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-21, 1397/05/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-efficacy training on quality of life and self-efficacy of stroke patients
Public title
Effect of self-efficacy training on quality of life and self-efficacy of stroke patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with confirmed ischemic stroke by CT scan or MRI
Patients who have been stroke for more than 4 months and less than two years
Patients in terms of severity of mild to moderate stroke are based on the contents of the case
Patients are in the age group of 55 to 70 years
Patients who have the ability to communicate verbally
Patients who receive an MMSE census score of more than 18 points
Exclusion criteria:
History of previous stroke
Previous training on self-efficacy
Age
From 55 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected on the basis of the criteria for entering the study, and are assigned by random appointment and randomized block method, which consists of the first two groups of the intervention and the second two groups of control
Blinding (investigator's opinion)
Single blinded
Blinding description
The samples in the intervention and control group were unaware of which group were placed
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Welfare and Rehabilitation Sciences
Street address
Welfare and Rehabilitation Sciences., Kodakyar Ave., Daneshjo Blvd., Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2017-09-22, 1396/06/31
Ethics committee reference number
IR.USWR.REC.1396.285
Health conditions studied
1
Description of health condition studied
Stroke patients
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
The quality of life score
Timepoint
The beginning of the intervention and two months after the intervention
Method of measurement
Quality of life questionnaire for patients with stroke
2
Description
Self-efficacy score
Timepoint
The beginning of the intervention and two months after the intervention
Method of measurement
Self-efficacy questionnaire for chronic patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, in addition to receiving hospital routine care, the patient participates in 5 sessions of the group education that is based on the structures of the self-efficacy theory. These 90 minute sessions are conducted twice a week at the hospital. At the last session, a booklet containing the content of the training sessions will be provided to the intervention team.
Category
Rehabilitation
2
Description
Control group: In this research, only the routine care of the hospital, which includes physiotherapy and occupational therapy is provided. After the completion of the research, due to the ethical considerations, the contents of the training booklet are also provided to the control group