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The effect of self-management promotion model on quality of life and self-efficacy of patients with chronic heart failure.

Protocol summary

Study aim
The effect of self-management promotion model on quality of life and self-efficacy of patients with chronic heart failure discharged from Kashan Shahid Beheshti Hospital.
Design
A controlled, non-blinding, randomized clinical trial will be performed on 56 patients with chronic heart failure. A random number table will be used for randomization.
Settings and conduct
This study will be performed on patients with chronic heart failure discharged from Kashan Shahid Beheshti Hospital. In the intervention group, the self-management promotion model will be implemented. This model is in 6 steps. The intervention will be held in eight sessions (two sessions per week, each session for 20 minutes in one month). Data will be collected using a three-part questionnaire including demographic characteristics, minnesota living with heart failure questionnaire (MLHFQ), and the sullivan cardiac self-efficacy questionnaire at three-time intervals (before, immediately, and one month after intervention).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) consent to participate in the present study, 2) age 18 to 65 years, 3) a definitive diagnosis of heart failure at discharge (Class 2 (EF=30% to 45%) and 3 (EF <30%) Heart failure), 4) classes 2 and 3 based on the New York Heart Failure Criterion, 5) having a medical sphygmomanometer and scales, 6) ability to call and follow up Non-inclusion criteria: 1) patients with underlying diseases such as chronic renal failure, liver cirrhosis in the past month, and cancer, 2) have mental illness, 3) inability to self-care, and 4) participate in another study at the same time.
Intervention groups
Conventional care will be performed in the control group. In the intervention group, the self-management promotion model will be implemented.
Main outcome variables
Quality of life and self-efficacy of patients with chronic heart failure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201018049059N1
Registration date: 2021-05-31, 1400/03/10
Registration timing: registered_while_recruiting

Last update: 2021-05-31, 1400/03/10
Update count: 0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Mohammad Javad Ghazanfari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 7545
Email address
javad.ghazanfari12@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management promotion model on quality of life and self-efficacy of patients with chronic heart failure.
Public title
The effect of self-management promotion model on quality of life and self-efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the present study Age 18 to 65 years A definitive diagnosis of heart failure at discharge (Class 2 (EF=30% to 45%) and 3 (EF <30%) Heart failure) Classes 2 and 3 based on the New York Heart Failure Criterion Having a medical sphygmomanometer and scales Ability to call and follow up
Exclusion criteria:
Patients with underlying diseases such as chronic renal failure, liver cirrhosis in the past month, and cancer. Have mental illness. Inability to self-care. Participate in another study at the same time.
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: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by permuted block randomization method. First, 6 blocks of 4 consisting of two letters A and B will be prepared and we will assign a number from 1 to 6 to each of them. Then, using the random number table, the numbers 1 to 6 are selected (15 numbers). Finally, a sequence of 60 letters A and B will be obtained. Each sample will have a number from 1 to 60 if they include the present study, and each person will receive an A or B code based on the number in the list. Also, blinding will not be done due to face-to-face training.
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 Kashan University of Medical Sciences
Street address
Isfahan, Kashan, Ghotb Ravandi Blvd., Hekmat 56, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159-73474
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.079

Health conditions studied

1

Description of health condition studied
Chronic Heart Failure Patients
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Quality of life
Timepoint
In three time periods (before, immediately, and one month after the intervention)
Method of measurement
Minnesota Living with Heart Failure Questionnaire

2

Description
Self-efficacy
Timepoint
In three time periods (before, immediately, and one month after the intervention)
Method of measurement
Sullivan Cardiac Self-Efficacy Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The self-management promotion model will be implemented in the intervention group. This model includes steps 1) case selection, 2) identifying patients' problems, 3) formulating a care plan, 4) implementing the intervention, 5) evaluation and 6) continuous monitoring of the patient's condition. The intervention will be held in eight sessions (two sessions per week, each session for 20 minutes in one month). Data will be collected using a three-part questionnaire including demographic characteristics, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and Sullivan Cardiac Self-Efficacy Questionnaire at three time periods (before, immediately, and one month after the intervention). Educational content will be provided to participants using pamphlets, booklets, and educational videos.
Category
Rehabilitation

2

Description
Control group: Eligible participants in the control group will receive conventional care. conventional care includes in-hospital and discharges training according to Brunner & Suddarth's Medical-Surgical Nursing 14th Ed (2018) in relation to disease-related care such as diet, nutrition, fluid intake, possible complications of the disease. In the present study, these trainings are provided by the researcher. Patients will complete the questionnaires in person before providing routine care. The researcher will also follow up on participants' quality of life and self-efficacy in the eighth week by asking questions via telephone.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Mohammad Javad Ghazanfari
Street address
Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 5554 0026
Email
javad.ghazanfari12@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Reza Afazel
Street address
Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
87159-73474
Phone
+98 31 5544 3022
Email
mohammadrezaafazel1338@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Javad Ghazanfari
Position
Student Research Committee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan Province, Kashan, Qutb Ravandi Blvd, hekmat 56, Kashan University of Medical Sciences and Health Services
City
Kashan
Province
Isfehan
Postal code
87159-73474
Phone
+98 11 3320 7545
Fax
Email
Javad.ghazanfari12@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Javad Ghazanfari
Position
Student Research Committee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan Province, Kashan, Qutb Ravandi Blvd, hekmat 56, Kashan University of Medical Sciences and Health Services
City
Kashan
Province
Isfehan
Postal code
87159-73474
Phone
+98 11 3320 7545
Fax
Email
Javad.ghazanfari12@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Javad Ghazanfari
Position
Student Research Committee
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan Province, Kashan, Qutb Ravandi Blvd, hekmat 56, Kashan University of Medical Sciences and Health Services
City
Kashan
Province
Isfehan
Postal code
87159-73474
Phone
+98 11 3320 7545
Fax
Email
Javad.ghazanfari12@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is 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
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers in the field of hemodialysis on request
From where data/document is obtainable
Contact the authors of the present study via email of the corresponding author. Email: Javad.ghazanfari12@gmail.com.
What processes are involved for a request to access data/document
Contact the authors of the present study via email of the corresponding author. Email: Javad.ghazanfari12@gmail.com.
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