The effect of self-management program on self-efficacy of stroke patients at discharge from university affiliated hospitals
Design
A randomized clinical trial with control,parallel, single-blind and randomized groups.Sample size consisted of 72 persons divided into two groups of Intervention and control groups.
Settings and conduct
The self-management program begins at the time of discharge from stroke patients and then goes home to complete the steps taken from Model 5A and continues with model stages including Assess, Advice, Agreement, Assistance, and Arrange. Initially, the needs assessment will be done, followed by a profit-and-loss guidance, followed by an agreed-upon training program between the trainer and the trainer. In the Assistance phase, the Assessment will be carried out with the Operational Plan, according to the 4 priority needs identified in the Agreement and with the Assessment Needs Assessment, and will ultimately be followed up by the ongoing program review
Participants/Inclusion and exclusion criteria
Willingness to participate in the study
Lack of global aphasia and Perceptive aphasia (ability to communicate at least)
Stroke for the first time
participating in other self-management and training studies
communication barrier
Intervention groups
Self-management program adapted from Model 5A for patients with stroke at discharge and begins with Assess, Advice, Agreement, Assist and Arrange for up to 12 weeks.For the control group we will follow up with follow-up phone calls during the training.
Main outcome variables
self efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190712044181N2
Registration date:2019-11-05, 1398/08/14
Registration timing:registered_while_recruiting
Last update:2019-11-05, 1398/08/14
Update count:0
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
shahla Abolhassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7548
Email address
abolhasani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management program on self-efficacy in stroke patients at the time of discharge from hospitals
Public title
The effect of self-management program on self-efficacy of stroke patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Lack of global aphasia and Perceptive aphasia (ability to communicate at least)
Stroke for the first time
Exclusion criteria:
Participating in other self-management and training studies
Communication barriers
Age
From 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Tool
Blinding (investigator's opinion)
Double blinded
Blinding description
A double-blind study, in which individuals such as the researcher and participants were blind. By using randomization tool (envelope in asymptomatic package), individuals are divided into two groups of test and control.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
Approval date
2019-09-27, 1398/07/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.387
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
The primary outcome variable is the self-efficacy score of patients with stroke self-efficacy questionnaire.
Timepoint
Before the intervention, immediately after the intervention and three months after the intervention
Method of measurement
Using visual self-efficacy questionnaire for patients with stroke
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After selecting the samples by random sampling and entering the study, the intervention will start with self-management method based on Model 5A. First and Second Stage: Assessment and Guidance The same needs assessment is done. Stage Three: Agreeing on the five basic needs for defining and fulfilling behavioral goals. Stage Four: The help stage is a need assessment performed with the help of professors and based on evidence of nursing services. Psychiatric nursing and physiotherapy. The fifth step is follow-up, which is by phone call, in-person appointment, and self-report check.
Category
Behavior
2
Description
Control group: Control group: After random selection in the control group, they will receive training (verbal, brochure and pamphlet) according to the hospital training by the ward nurse for home care. They will be followed up for a 12-week follow-up, as in the internal team, and will be reminded of their discharge training by phone once a month.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Educational Center
Full name of responsible person
Mehdi Nasr Isfahani
Street address
Soffeh Blvd; Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
81746757731
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Amin Medical Educational Center
Full name of responsible person
Mohamad Ali Pourmirzaei
Street address
Sonbolestan Alley; Ibne Sina Ave; Amin Hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 34 4531 5051
Email
Amin@mui.ac.ir
3
Recruitment center
Name of recruitment center
Kashani Medical Educational Center
Full name of responsible person
Iman Adibi
Street address
Ayatollah Kashani Ave.Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3233 0091
Email
Kashani@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar jareeb Ave;
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Web page address
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
Shahla Abolhassani
Position
Assistant professor of nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7548
Email
abolhasani@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Abolhassani
Position
Assistant Professor of Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7548
Email
abolhasani@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Abolhassani
Position
Assistant Professor of Nursing Educational
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7548
Email
abolhasani@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The original data can be shared after identifying individuals (using code for each individual) and adhering to the privacy principle in the thesis file and the extracted article.
When the data will become available and for how long
Start access to thesis file 6 months after student's final thesis defense; Start accessing the article file immediately after printing
To whom data/document is available
Anyone, whether academics or researchers working in other institutions, including the private sector, can apply for shared data.
Under which criteria data/document could be used
To use the results of this study to plan for more comprehensive similar studies or to use the results of this study to design appropriate supportive educational interventions for patients.
From where data/document is obtainable
Isfahan University of Medical Sciences; School of Nursing and Midwifery; Department of Adult Health Education; Dr. Shahla Abolhasani Phone 00989131095395
abolhasani@nm.mui.ac.i
What processes are involved for a request to access data/document
Within 7 business days of receiving a written request by email and a full description of the applicant, together with the organization or institution in which they work and where the data is used; Documentation can be sent.