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Evaluation of the effect of self-management program based on 5 A's model (Assess, Advise, Agree, Assist, Arrange) on the quality of life on hemodialysis patients

Protocol summary

Study aim
1- Determining the mean scores of quality of life dimensions before and after in the intervention and control groups in hemodialysis patients 2- Comparison of mean scores of quality of life dimensions before and after the implementation of model 5A between intervention and control groups in patients
Design
This clinical trial study will be performed on 60 hemodialysis patients with a control and intervention group, not blinded, randomized by permutation block method (prepared by a statistician)
Settings and conduct
After receiving the code of ethics and the letter of introduction from the university, the researcher will refer to the dialysis unit of Imam Ali Andimeshk Hospital. Sampling will be convenient method and based on the inclusion criteria. For random allocation of samples to the intervention and control groups, through 4 blocks will be used.
Participants/Inclusion and exclusion criteria
Admission requirements: Literacy of reading and writing, willingness to participate in the study, no history of mental health problems, age range 18 to 65 years, Conditions of non-admission: Existence of other underlying diseases such as diabetes, heart disease, cancer, cognitive impairment such as Alzheimer's and amnesia
Intervention groups
Intervention group: are trained and implement a self-management program based on Model 5A. The 5 steps include: reviewing, guiding, agreeing with the patient to realistically set goals, helping to develop a practical plan, and tracking performance. Control group: other than routine ward interventions; They will not receive any other intervention
Main outcome variables
Quality of life of hemodialysis patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211103052955N1
Registration date: 2021-11-19, 1400/08/28
Registration timing: prospective

Last update: 2021-11-19, 1400/08/28
Update count: 0
Registration date
2021-11-19, 1400/08/28
Registrant information
Name
Sahar Keivan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4263 1893
Email address
keivan.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of self-management program based on 5 A's model (Assess, Advise, Agree, Assist, Arrange) on the quality of life on hemodialysis patients
Public title
Evaluation of the effect of self-management program based on 5 A's model on the quality of life on hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy of reading and writing Willingness to participate in the study No history of mental health problems Age range 18 to 65 years
Exclusion criteria:
Existence of other underlying diseases such as diabetes, heart disease, cancer Cognitive impairment such as Alzheimer's and amnesia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples by random blocking method with 4 blocks in the form of 6 different modes and using It will be determined from the table of random numbers of the software. Blocking and allocation sequence, It will be done by a statistician in such a way that 6 different modes will be created for 4 blocks. Then, based on the obtained blocks and the sequence of random allocation, patients will be placed in two experimental and control groups. Blinding will not occur in this study.
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 Ahwaz Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences; Golestan Street., Golestan Blvd., Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
6314748679
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.AJUMS.REC.1400.465

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life dimension scores before and after the implementation of Model 5A between the intervention and control groups in patients
Timepoint
Before the intervention and three months after the start of the intervention in both groups
Method of measurement
Using Kidney Patients Quality of Life Questionnaire (KDQOL-SF)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: The first step of the evaluation stage: In this stage, the patient is examined for risk factors, disease history, kidney problems, adherence to medication, sleep status, nutrition, activity and information in the file through face-to-face interview. The second step of the guidance stage: In this stage, according to the results of the previous stage, the identified health risks will be informed to the patient and the benefits of behavior change will be emphasized. Step 3: Agree with the patient in realistically setting goals: An agreement is reached between the patient and the researcher about the patient's performance. According to the identified problems, appropriate and agreed behavioral goals with the patient will be determined and for each goal, a practical plan will be designed. For each behavioral goal, a standard requirement of zero to 10 is identified. These items will be recorded on the Behavioral Goals Form and patients will be asked to record their performance status for each Behavioral Goal on a weekly basis for 12 weeks. The fourth step in helping to develop a practical plan: training such as how to control fluid intake, how to care for vascular access, the importance of exercise and physical activity, skin care, diet and medication, etc. face to face Patients will be asked to perform these exercises daily and record their performance. In addition, according to the needs of patients, an individual training session will be arranged according to the patient's wishes in person or by phone in order to repeat and emphasize the items taught to patients. Step 5 Performance follow-up: At this stage, patients' performance will be followed for three months. In fact, to ensure the implementation of practical programs by patients in the first four weeks by phone or text message 3 times a week and from the fifth to the twelfth week, once a week until the end of the intervention, follow-up is done, to do Remind the practical plan and solve possible problems of patients. In addition, the patient's progress will be monitored in a face-to-face session every four weeks. In this meeting, the agreed action plan and behavioral goals will be reviewed, so that if there is a need to change the goals or action plan, the necessary changes will be made by re-agreeing, strengthening and encouraging the continuation of the intervention.
Category
Lifestyle

2

Description
Control group: In the control group other than routine Unit interventions; They will not receive any further intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Sahar Keivan
Street address
Imam Ali Hospital; Ahwaz-Andimeshk ring road; Andimeshk Town
City
Andimeshk
Province
Khouzestan
Postal code
6314748679
Phone
+98 61 4264 1872
Email
Keivan.s@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Sahand Jorfi
Street address
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6314748679
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sahar Keivan
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6314748679
Phone
+98 61 3336 2414
Email
Keivan.s@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahar Keivan
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1474867963
Phone
+98 61 3336 2414
Fax
Email
Keivan.s@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahar Keivan
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences، Deputy of research and technology،Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6314748679
Phone
+98 61 3336 2414
Email
Keivan.s@ajums.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
No - There is not 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
Some similar information related to the main message or the like can be shared
When the data will become available and for how long
Immediately after the final publication of the article, it is possible to access the protocol and findings of the article
To whom data/document is available
Access is available to everyone
Under which criteria data/document could be used
The use of methodology and tools is unrestricted
From where data/document is obtainable
Refer to the Co-Responsive author of the article for Received any information
What processes are involved for a request to access data/document
Email the responsive author to receive any information
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