Determining the impact of health literacy promotion on self-care in patients with heart failure
Design
Randomized clinical trial, control and intervention groups
Settings and conduct
In this study, patients will be divided into two groups of intervention and control, through table of random numbers. For both groups, intervention and control, before and after study, Self-care and demographics questionnaire will be completed. This study will be done in oil and Rajaie hospitals and private clinics of Gachsaran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age 35 to 75
2. Ability to speak Persian, having reading and writing skills
3. The ejection fraction of less than 45%
4. Satisfaction to participate in the research
5. Access to WhatsApp and the ability to use Cyberspace.
Exclusion criteria:
1. Cases of other diseases such as chronic kidney disease, liver cirrhosis and cancers
2. Having a mental illness
Intervention groups
the intervention, will be provided 4section to the intervention group through electronic cyber (software ispring)The control group received only routine training.
Main outcome variables
Self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043021N1
Registration date:2020-05-02, 1399/02/13
Registration timing:retrospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Khadijeh Saberi nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3233 3728
Email address
khadijeh.saberi428@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-09-22, 1398/06/31
Trial completion date
2019-12-06, 1398/09/15
Scientific title
The effect of health literacy promotion through virtual education on the self-care of heart failure patients
Public title
effect of health literacy promotion on heart failure patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 35 to 75 Cyberspace.
Ability to speak Persian, having reading and writing skills3.
The ejection fraction of less than 45% based on the patient's echocardiography
Satisfaction to participate in the research
Access to WhatsApp and the ability to use
Exclusion criteria:
Cases of other diseases such as chronic kidney disease, liver cirrhosis and cancers
Inability to take care of yourself
Having a mental illness
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, table of random numbers and an online software (from www.random.org/integers website) will be used to divided patients into two groups of intervention and control.
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
Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
Department of Nursing, School of Medical Science, Yazd Branch, Islamic Azad University,Gomham Shohaday Bolvar,Safaey Yazd, Iran
City
yazd
Province
Yazd
Postal code
8915813135
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.062
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Self-care
Timepoint
Self-care measurement before intervention and one month after training
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Educational content will be provided for intervention group through electronic cyberspace (ispring software) in four sessions. In first sessions, definition of heart failure, mechanism, reasons and the cause of heart failure symptoms and also under what circumstances should the patient see his or her doctor, will be explained.Second session will contain symptoms, diagnosis, general principles of treatment of heart failure, which contains pharmacological and surgical treatment, non-pharmacological management of heart failure and increasing factors of heart failure Risk.Third session Includes activity and rest in heart failure patients, contact or visiting a doctor and How to control daily weight.In fourth session, diet in heart failure patients, obesity control, smoking, Influenza injection time, will be studied.
Category
Lifestyle
2
Description
Control group will only receive routine training which includes training given by nurses while the patients are admitted in hospitals or when they visit a doctor private clinic.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialty Clinics of Rajaee Hospital and Oil Hospital
Department of Nursing, School of Medical Science, Yazd Branch, Islamic Azad University,Gomham shohaday Bolvar,Safaey Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Email
khadijeh.saberi428@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Yazd Branch, Islamic Azad University, Yazd, Iran
Full name of responsible person
Masoumeh Barkhordari Sharifabad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Department of Nursing, School of Medical Science, Yazd Branch, Islamic Azad University,Gomham Shohaday Bolvar,Safaey Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Email
khadijeh.saberi428@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Branch, Islamic Azad University
Full name of responsible person
Maasoumeh Barkhordari Sharifabad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Department of Nursing, School of Medical Science, Yazd Branch, Islamic Azad University,Gomham Shohaday Bolvar,Safaey Yazd, Iran
City
yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Email
Khadijeh.saberi428@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd Branch, Islamic Azad University
Full name of responsible person
Masoumeh Barkhordari Sharifabad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Department of Nursing, School of Medical Science, Yazd Branch, Islamic Azad University,Gomnam Shohaday Bolvar,Safaey Yazd, Iran
City
یزد
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Email
khadijeh.saberi428@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shared after unidentifiable people
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
This data will be of use to medical science researchers for further analysis
From where data/document is obtainable
(Yazd Azad University, School of Nursing)
What processes are involved for a request to access data/document
Applicant from the Research Department of the University of Origin Apply to the Research Department of the destination university (Yazd Azad University, School of Nursing)