To examine the effectiveness of an intervention program in enhancing heart failure-specific health literacy among patients with heart failure.
Design
A quasi-experimental design was employed to achieve the aforementioned objectives. 64 subjects will be assigned to Join the study group. The rest will be in the control group. The total sample size would be 128 subjects.
Settings and conduct
A 128 heart failure patients , who were visiting outpatient clinic in 3 major teaching hospitals at Maysan City. Study subjects were recruited when they were seeking the follow-up of their health problems and prescriptions refilling.The simple randomization procedure would involve throwing a dice (eg, below & equal to 3 = control, over 3 = treatment). No allocation concealment will be carried out.
Participants/Inclusion and exclusion criteria
Inclusion: *Consent & compliance with all aspects of the study protocol, methods, providing data during follow-up phase.*Contact male & female patients, who are 18-70 years old at the time of data collection phase Exclusion:*Involvement with any other ongoing studies. *Medically diagnosed with psycho-mental diseases *Morbidly ill subjects, whereas their physical & mental capacity are impaired
Intervention groups
Intervention group: The starting point of the intervention phase will start by asking the subjects to respond to “ Heart Failure Specific Health Literacy scale ” ( linkopings University, 2016). This mandatory step will help in categorizing the subjects according to their health literacy level. Intervention group subjects will be armed with orally & in a written form of simple, yet specific instructions to enable them managing their health literacy . The intervention group will be contacted after 14 days to see the influence of the given instruction on their health literacy level status.
Main outcome variables
Improvement of health literacy level
General information
Reason for update
Acronym
Improving health literacy trial ( IHLT)
IRCT registration information
IRCT registration number:IRCT20220924056029N1
Registration date:2023-01-15, 1401/10/25
Registration timing:retrospective
Last update:2023-01-15, 1401/10/25
Update count:0
Registration date
2023-01-15, 1401/10/25
Registrant information
Name
Sarah Hassan
Name of organization / entity
University of Baghdad college of Nursing
Country
Iraq
Phone
+964 781 216 2020
Email address
sarra.falaah1102b@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-09, 1400/12/18
Expected recruitment end date
2022-11-17, 1401/08/26
Actual recruitment start date
2022-07-31, 1401/05/09
Actual recruitment end date
2022-11-17, 1401/08/26
Trial completion date
2022-11-17, 1401/08/26
Scientific title
The Effect of a Nurse-Led Educational Intervention on Health Literacy of Patients Who are Medically Diagnosed With Heart Failure
Public title
Intervention program for patient with Heart Failure Specific Health Literacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent & compliance with all aspects of the study protocol, methods, providing data during follow-up phase Contact male & female patients, who are 18-70 years old at the time of data collection phase
Exclusion criteria:
Involvement with any other ongoing studies. Medically diagnosed with psycho-mental diseases Morbidly ill subjects, whereas their physical & mental capacity are impaired
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2022-07-29, 1401/05/07
Ethics committee reference number
2395
Health conditions studied
1
Description of health condition studied
Heart Failure Specific Health Literacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improvement of Health literacy level
Timepoint
Subjects response to the educational intervention will be within two weeks of the first meeting to examine the effectiveness of the intervention on health literacy level
Method of measurement
Self-report of health literacy level after being exposed to the intervention program
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The starting point of the intervention phase will start by asking the subjects to respond to Heart failure specific health litrecy scale (linkopingsUniversity,2016). This mandatory step will help in categorizing the subjects according to their smoking trigger. Intervention group subjects will be armed with orally & in a written form of simple, yet specific instructions to enable them managing their dominant smoking trigger. The intervention group will be contacted after 14 days to see the influence of the given instruction on their smoking status.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The outpatient clinic of the AL Sadar Teaching Hospital , Maysan Center for Heart Disease and Surger
Full name of responsible person
Sarah F.Hassan
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
Email
Sarra.Falaah1102b@conursing.uobaghdad.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Huda Baqer, PhD. Dean
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sarah F.Hassan
Position
PH.Dc
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Bab AL-Muadum
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
0098478012162020
Email
Sarra.Falaah1102b@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sadeq AL-Fayyadh
Position
Faculty member-An Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
s.al-fayyadh@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Sarah F.Hassan
Position
PH.Dc
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Bab AL-Muadum
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
009847812162020
Email
Sarra.Falaah1102b@conursing.uobaghdad.edu.iq
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
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
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: s.al-fayyadh@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors