Determine the Effect of Self-Management Program Based on five A Model on Quality of Life in Patients with Stroke.
Design
Clinical trial with community based and pragmatic control group, single, non-blind and non-random
Settings and conduct
Self-management training based on five A model on stroke patients referring to Rasoul-e-Akram Hospital in Tehran, which will be carried out in pre-test and post-test in two groups: intervention and control
Participants/Inclusion and exclusion criteria
People with stroke and their ability to be trained
Intervention groups
Self-management training based on the Five A model
The main goal of self-management education is based on the five A model: achieving maximum independence, self-decision making, health promotion based on individual's abilities and lifestyle, as well as improving quality of life.
In this research, the Five A model has been used as a self-management framework in the intervention group to evaluate its effectiveness in improving the quality of life of stroke patients.
The control group has routine health and rehabilitation care and at the end of the intervention will receive self-management training package.
Main outcome variables
Quality of life in stroke patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190104042226N1
Registration date:2019-04-02, 1398/01/13
Registration timing:registered_while_recruiting
Last update:2019-04-02, 1398/01/13
Update count:0
Registration date
2019-04-02, 1398/01/13
Registrant information
Name
Homa Khorsandi Sani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 2817
Email address
homa.khorsandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management program based on the five A model on quality of life of patients with stroke.
Public title
The effect of self-management training on quality of life of patients with stroke.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of a stroke by a neurologist
Possibility of self-care and training
The absence of another known chronic disease, such as cancer, MS, Parkinson
Research units are not from the medical group
Not participating in the same study
Consent to participate in research
Having a score of 8 or higher in abbreviated mental test.
Exclusion criteria:
Having any disabling physical and psychological disorder.
Any changes in the patient's condition that require emergency measures.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
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 the University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences Tehran,Childhood Deadend, Evin, Student Blvd,
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2018-12-21, 1397/09/30
Ethics committee reference number
IR.USWR.REC.1396.404
Health conditions studied
1
Description of health condition studied
Quality of life for patients with stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Quality of life in stroke patients
Timepoint
At the beginning of the study (before the intervention) and at the end of intervention (after 45 days)
Method of measurement
Specific Quality of Life Questionnaire for Patients with Stroke
Secondary outcomes
empty
Intervention groups
1
Description
1.Intervention group: Self-management training 5 A model :(1.Assess 2. Advise 3.Agree 4.Assist 5. Arrange) The five steps include: 1. Assessing the patient's behavioral level, beliefs and motivations; 2. Guide the patient about personal hygiene and risk factors; 3. Interact with the patient on the actual selection of objective goals; 4. Estimate barriers and program predictions, Practical 5. Track and support and setup . This program will run for 45 days.In the first week, the first three sessions are run in a 1.5 hour session individually. At this stage, the patient's health and lifestyle issues are being studied and goals are addressed to address the problems and improve the quality of life of patients .And the self-management training program will be tailored to the needs of each patient. In the second week, the fourth stage will be implemented. This stage will be held in a session of 30 to 60 minutes to help with the practical program, and the patient's problems will be resolved in relation to the self-management program.In the next four weeks, the fifth step is to follow the patient's performance and support them by telephone. Educational contents include information on patient needs, problem-solving skill training and time management skills, as well as stress management skills and crisis management in life, and ultimately self-confidence promotion strategies that are tailored to the needs of the patients.
Category
Lifestyle
2
Description
Control group:The control group did not receive a Five A Self-Management Training Program during the 45 days and received only a routine rehabilitation and treatment center program. At the end of the program, the five A self-management training package was provided to the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Homa khorsandi sani
Street address
Rasoul Akram Hospital,.Niyayesh Ave.,Statarkhan Ave.,Tehran Town
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 9595
Fax
+98 21 6651 6999
Email
homa.khorasandi@yahoo.com
Web page address
http://hrmc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Homa Khorsandi
Street address
University of Social Welfare and Rehabilitation Sciences Tehran, Evin, Student Blvd, Childhood Death
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
Homa.khorsandi@yahoo.com
Web page address
https://www.uswr.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
homa khorsandi sani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Childhood Death Alley.,Evin, Student Blvd.,University of Social Welfare and Rehabilitation Sciences Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
homa.khorsandi@yahoo.com
Web page address
https://www.uswr.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Homa Khorsandi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Evin, Student Blvd, Childhood Death .,University of Social Welfare and Rehabilitation Sciences Tehran,
City
tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
Homa.khorsandi@yahoo.com
Web page address
https://www.uswr.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Homa Khorsandi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of Social Welfare and Rehabilitation Sciences Tehran, Evin, Student Blvd, Childhood Death
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
Homa.khorsandi@yahoo.com
Web page address
https://www.uswr.ac.ir/
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