Determining the effect of family-oriented self-care education through smartphones on health literacy and self-care status of heart failure patients in Jahrom city in 2023
Design
The clinical trial has a control group, with parallel groups without blinding, randomized on 60 patients, which will be written in a list for randomization, and one in the middle will be assigned to the intervention and control groups.
Settings and conduct
In this research, researchers first refer to Imam Reza Art Clinic and Clinic, located in Jahrom City, and add the patients who meet the inclusion criteria to the study with the help of a cardiologist. After completing the samples and performing randomization, a group will be formed for the families of the patients in the intervention group in ITA, and training sessions, which include three sessions, will be sent to them on a weekly basis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 18 to 65 years
Not having known psychological problems
Being in the 2nd class of heart failure as diagnosed by a cardiologist
Having a primary caregiver (such as a spouse or children)
The ability of primary caregivers to access smartphones
Being literate in reading and writing
Exit criteria:
Absence in more than two training sessions
death of the patient
Intervention groups
In the intervention group, self-care training will be sent to the first-class members of the patients who have access to a smartphone in the Eita messenger, but the control group will only undergo routine training provided to them by the attending physician.
Main outcome variables
Education via smartphone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210114050037N2
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
َAli asghar Rahmanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 3628
Email address
lynurse8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-center self-care training through smartphones on health literacy and self-care status of patients with heart failure
Public title
The effect of family-center self-care training through smartphones on health literacy and self-care status of patients with heart failure in Jahrom city in 2023
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 18 to 65 years
Not having known psychological problems
Being in the 2nd class of heart failure as diagnosed by a cardiologist
Having a primary caregiver (such as a spouse or children)
The ability of primary caregivers to access smartphones
Being literate in reading and writing
Exclusion criteria:
Absence in more than two training sessions
death of the patient
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
Random allocation of samples is done using the block method and through statistical software.
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 Jahrom University of Medical Sciences
Street address
At the end of Ostad Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2023-08-21, 1402/05/30
Ethics committee reference number
IR.JUMS.REC.1402.054
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure
Primary outcomes
1
Description
health literacy
Timepoint
Measuring health literacy before the implementation of the educational intervention and one month after the implementation of the educational intervention
Method of measurement
Heart failure health literacy questionnaire
2
Description
self-care status
Timepoint
Measuring the state of self-care before the implementation of the educational intervention and one month after the completion of the educational intervention
Method of measurement
Questionnaire to measure the self-care status of patients with heart failure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An active member of the family who can participate in education is selected. It means the patient's family members, child, spouse, or one of the causal or relative relatives who accompany him in the treatment process in order to get better and improve his level of health. This person should be more capable than others in terms of companionship, decision-making power, giving importance, and understanding the patient's condition. The educational content in this group is fully provided to the active member of the family and he is asked to implement the learned instructions for the patient. After selecting the first-degree relatives, a group will be formed for all patients of the intervention group in a virtual space (preferably Eita software) and all the members of the group will be members of it. The trainings are uploaded in the form of audio files on a certain day of the week in the group and family members are given the opportunity to review it.One to two days after uploading the file, the researchers communicate with the family members by phone to make sure that they have listened to the material and given appropriate feedback and transferred it to the patient. Number of training sessions 3 sessions and duration Each session will be 20 to 30 minutes. In addition, the group is open during the meetings and family members will have the opportunity to discuss and express their concerns.
Category
Other
2
Description
Control group: During the time that the patients are being trained through the smartphone, the patients of the control group only receive routine training provided by the doctor and nurses and are not under any training by the researcher.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Honari Specialty and sub specialty clinic
Full name of responsible person
Ali asghar Rahmanian kushkaki
Street address
Ostad Motahari Boulevard, above Ostad Motahari Hospital, corner of the alley25
City
Jahrom
Province
Fars
Postal code
7415713945
Phone
+98 71 5434 2006
Email
honariclinic@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
kavoos solhjoo
Street address
At the end of Ostad Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5444 0821
Email
Solhjoo@JUMS.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Ali asghar Rahmanian kushkaki
Position
Non faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mother Boulevard 17
City
Jahrom
Province
Fars
Postal code
7415854139
Phone
+98 71 5433 3628
Email
Lynurse8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
zohreh Badiyepeymaie Jahromi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ostad Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 917 392 4707
Email
z.badiyehpeyma@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Ali asghar Rahmanian kushkaki
Position
Non faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mother Boulevard, 17th Street
City
Jahrom
Province
Fars
Postal code
7415854139
Phone
+98 71 5433 3628
Email
Lynurse8@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available