Determining the effect of health literacy INDEX-based education on knowledge, self-care behaviors and readmission in heart failure patients
Design
Randomized clinical trial; with control group, parallel groups, without blindness
Settings and conduct
Selection of 90 patients with heart failure hospitalized and divided into two groups: control and intervention with simple random assignment. Educational intervention based on health literacy index, individual and group, with 8 to 12 patients in each group weekly with the presence of a family member in the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
History of heart failure diagnosis for at least one year; Have ability to read and write; Ejection fraction less than 40% diagnosed by a specialist; Class II and III of heart failure; No diagnosed psychological disorders; Hospitalization for the first time; Living with a family member.
Exclusion Criteria:
Dissatisfaction with the patient to continue cooperation at the time of the intervention; Patient entry to class IV heart failure; Not attending workshops even for one meeting; Patient death; Lack of access to the patient at the end of the intervention.
Intervention groups
The control group will receive care, medication orders and routine clinic recommendations. For the experimental group, individual training sessions based on the literacy index in 3 sessions based on the health literacy dimensions in the heart clinic class of the Amini Hospital of Langeroud Hospital will be performed once a week and with the presence of active member of the patient's family. Then, for exchanging information with peers, sharing information and expressing experiences, two workshops for the entire test group will be held on a weekly basis with 8 to 12 patients per group.
Main outcome variables
Self-care; knowledge about heart failure; readmission after 30 days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100725004443N27
Registration date:2019-05-28, 1398/03/07
Registration timing:registered_while_recruiting
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Health Literacy INDEX-based Education on Knowledge, Self-care Behaviors and Readmission in Heart Failure Patients
Public title
The Effect of Health Literacy INDEX-based Education on Knowledge, Self-care Behaviors and Readmission in Heart Failure Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with heart failure
Patients who their illness has been diagnosed since the past year
Exclusion criteria:
Unwilling to presence in the research
Age less than 18 years
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected by continuous sampling and the patients will be placed in two groups of control and case by Block Balanced Randomization (BBR). By using the free web site http://www.randomization.com/, the assignment sequence will take place. In such a way that the number of subjects in each block will be set to 5, for the control group letter A and for the case group, the letter B will be considered, and finally by approving the Randomization Sequence in the system for 18 blocks , The assignment sequence will be created for the 90 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, allocation concealment will be considered and observed. Based on qualified samples, an Shuffling Envelope will be taken by the researcher accidentally. Finally, the random allocation method will be determined by the research samples.
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 Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Quds St, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-09-02, 1397/06/11
Ethics committee reference number
IR.TUMS.FNM.REC.1397.106
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Self-care
Timepoint
Before the intervention and 3 weeks after the end of the intervention
Method of measurement
Self- care Heart Failure Index
2
Description
Heart failure knowledge
Timepoint
Before the intervention and 3 weeks after the end of the intervention
Method of measurement
Dutch Heart Failure Knowledge Scale
3
Description
Readmission
Timepoint
30 days after the end of the intervention
Method of measurement
Self report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training based on the health literacy index, using the educational manual and the general content, regarding that the dimensions of self-care includes maintenance (sustainability of physiological status), management (response to symptoms at the time of occurrence), and self-care confidence will be taught in 3 Individual 60-minute sessions and then exchange with peers, sharing information, expressing experiences in response to symptoms and self-care methods, after conducting an individual training session, two workshops for all the test group will be attended by 8 Up to 12 patients in each group on a weekly basis at the Clinic of the heart of Amini Hospital in the agreed hours and upon request by the nurse-researcher will be held. The group members will be held for at least 60 minutes. During counseling sessions, telephone counseling with patients (once a week) based on the needs of patients with content encouraging compliance with care education, hearing patient speeches and answering questions will be done.
Category
Behavior
2
Description
Control group: The control group, care, medication orders and routine clinic recommendations include advice on the timely use of medications and pamphlets associated with the disease.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amini Hospital of Langeroud City
Full name of responsible person
Dr Seyyed Ali Mir Hashemi
Street address
Langeroud, Emam Khomaini st
City
Langeroud
Province
Guilan
Postal code
4188794755
Phone
+98 13 4252 4005
Fax
+98 13 4252 3800
Email
amini_hospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Keshavarz Blvd., Ghods St., Central Organization of the University, 6th floor of Research and Technology Department
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Roya Khorrami Estakhri
Position
Master Student of Critical Care Nursung
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
r.m.kh.69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Zakeri Moghaddam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
mzakerimo@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Khorrami Estakhri
Position
Master Student of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
r.m.kh.69@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