Determination the effect of educational program on the health literacy and life quality and adherence in patients with heart failure.
Design
The present study is a clinical trial with a control group with parallel random groups of 60 people. The intervention is randomly assigned to two groups using a randomized block method (15 quadruple blocks).
Settings and conduct
This study is a randomized, controlled clinical trial. site of research is Kashan Shahid Beheshti Hospital and the Doctor's office in Aran and Bidgol and Kashan. The questionnaires are completed twice ; first before the training, then 4 weeks after completing the training
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of heart failure by a cardiologist, Age at least 18 years, Consent to participate in the study.
Exclusion criteria: Participants' reluctance to continue the research, Acute illness or special conditions that lead to hospitalization or death, Absence of more than two sessions in training classes
Intervention groups
In the intervention group, training programs in groups of 10 people will be held in 5 sessions of face-to-face training of 30-45 minutes once a week by the first researcher in Kashan Shahid Beheshti Hospital. Control group: will not receive any intervention.
Main outcome variables
Health literacy; Qquality of life; Adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190606043829N1
Registration date:2021-08-07, 1400/05/16
Registration timing:registered_while_recruiting
Last update:2021-08-07, 1400/05/16
Update count:0
Registration date
2021-08-07, 1400/05/16
Registrant information
Name
Amir Arsham Kobraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4475 2770
Email address
arsham.kobraei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational package on health literacy, quality of life and adherence in patients with heart failure.
Public title
The Effect of Education on Health Literacy, Quality of Life and Adherence in Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of heart failure by a cardiologist
Age of at least 18 years
Having the consent to participate in the study
Exclusion criteria:
Participants' reluctance to continue the research
Acute illness or conditions requiring medical attention during the study period.
Absence of more than two sessions in training classes
Age
From 18 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
The sampling method will be available (selection among patients with heart failure) and based on inclusion criteria. Then, the samples will be determined by block randomization method (15 blocks of four) and using the random number table of Allocation Random software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research (Allocation Concealment).The sample allocation ratio (Allocation 1:1) will be in two groups of intervention and control (Assignment). Then, based on the obtained blocks and in the order of allocation, the trainings will be given to the patients. 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 Kashan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
815981158
Approval date
2019-09-02, 1398/06/11
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.038
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
Health literacy
Timepoint
Pre-training and 4 weeks after completing the training
Method of measurement
Specific health literacy questionnaire for heart failure patients
2
Description
Quality of Life
Timepoint
Pre-training and 4 weeks after completing the training
Method of measurement
The minnesota living with heart failure questionnaire
3
Description
Adherence to treatment
Timepoint
Pre-training and 4 weeks after completing the training
Method of measurement
Madanlu treatment adherence questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The study is a clinical trial study. Patients who are enrolled, receive a booklet that includes the following:1-When it is necessary to call or go to a doctor, 2- The main points about nutrition and fluid intake, 3- What should be done if symptoms get worse, 4-Complications that occur if you do not take medications, 5- Quality and quantity of activities throughout the day. They also attend five full-time teaching sessions that are based on the booklet. Variables will be compared before and 4 weeks after the end of training.
Category
Prevention
2
Description
Control group: The control group receive routine training, including oral instructions from the department or clinic in relation to heart failure, but they do not receive the manual and attendance training. They will receive the booklet at the end of the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital, Kashan and Aran and Bidgol doctors' offices
Full name of responsible person
Amir arsham-kobraei
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
815981158
Phone
+98 31 5554 6633
Email
arshm.kobraei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Vice Chancellor of Research & Technology, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
815981158
Phone
+98 31 5554 6633
Email
banafshe_h@yahoo.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
Amir arsham-kobraei
Position
Master student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
815981158
Phone
+98 21 4475 2770
Email
arshm.kobraei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir arsham-kobraei
Position
Masters student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
815981158
Phone
+98 21 4475 2770
Email
arshm.kobraei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir arsham-kobraei
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
815981158
Phone
+98 21 4475 2770
Email
arshm.kobraei@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
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