Investigating the effect of an intervention based on Leventhal's self-regulation model on the level of health literacy and adherence in heart failure patients
Determining the effect of an intervention based on Leventhal's self-regulation model on the level of health literacy and adherence in heart failure patients
Design
In this study, 92 patients with heart failure who were hospitalized in Social Security Organization hospitals were selected through a convenience sampling method. Subsequently, participants were randomly assigned to intervention and control groups using a randomized block design with blocks of four. After obtaining written informed consent from the patients, the researcher completed demographic information questionnaires, the Heart Failure Health Literacy Questionnaire, and the Heart Failure Adherence Questionnaire for both groups.
The control group received only routine ward care, while the intervention group, in addition to routine care, underwent an educational intervention based on Leventhal's self-regulation model. This intervention was conducted individually and in person during three sessions of 30 to 40 minutes each during the hospitalization period. The questionnaires were re-administered one month and three months after the intervention
Settings and conduct
A total of 92 patients with heart failure hospitalized in the Social Security Organization hospitals of Qazvin will be selected using a convenience sampling method.
Participants/Inclusion and exclusion criteria
confirmed heart failure diagnosis by a cardiologist, informed consent, no known psychiatric disorder, and no participation in similar educational programs in the past 6 months
Exit criterion:
unwillingness to continue, severe disability or death, new acute debilitating illness, or missing any educational session
Intervention groups
The intervention group will receive training based on Leventhal's self-regulation model.
Main outcome variables
Health literacy – adherence in patients with heart failure
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20250713066474N1
Registration date:2025-07-24, 1404/05/02
Registration timing:prospective
Last update:2025-07-24, 1404/05/02
Update count:0
Registration date
2025-07-24, 1404/05/02
Registrant information
Name
Atefeh علیزاده ریسنی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
atefehalizaddeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-21, 1404/06/30
Expected recruitment end date
2026-01-10, 1404/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of an intervention based on Leventhal's self-regulation model on the level of health literacy and adherence in heart failure patients
Public title
Investigating the effect of Leventhal's self-regulation model on health literacy and adherence in heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of heart failure by a cardiologist
Informed consent to participate in the study
No known psychiatric disorders
No participation in a similar educational program in the past 6 months
Exclusion criteria:
Unwillingness to continue participation at any stage
Occurrence of severe disability or death
Development of a new debilitating acute illness
Absence from at least one educational session
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of four will be used for allocation. To determine the allocation sequence using block randomization, the online randomization tool available at https://www.sealedenvelope.com/simple-randomiser/v1/lists will be utilized. Randomization will be performed by an independent individual.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, 92 patients with heart failure who are hospitalized in Social Security Hospital of Qazvin and meet the inclusion criteria (confirmed diagnosis of heart failure by a cardiologist and willingness to participate in the study) will be selected using a convenience sampling method. The patients will then be randomly assigned to intervention and control groups using a four-block randomization method. After obtaining written informed consent from the patients, demographic information, the Heart Failure Health Literacy Questionnaire, and the Heart Failure Adherence Questionnaire will be completed by the researcher in both groups. The control group will receive only routine care, while the intervention group, in addition to routine care, will receive an educational intervention based on Leventhal’s self-regulation model, delivered individually and face-to-face during three sessions of 30 to 40 minutes each during hospitalizationEducational Sessions:Session 1:The content focuses on enhancing patients’ understanding of the disease, including explanations about the nature of heart failure, symptoms (shortness of breath, limb swelling, weakness, fatigue), causes (hypertension, coronary artery disease, valvular disease), disease progression, short- and long-term consequences (frequent hospitalizations, functional limitations), and the possibility of disease control through appropriate treatment. Misconceptions held by patients will also be identified and corrected. Techniques such as feedback provision, concrete examples, sharing experiences of successful patients, and short-term goal setting (e.g., weight loss, blood pressure control) will be employed.Session 2:After reviewing the content of the first session, this session emphasizes self-care aspects including adherence to an appropriate diet (reducing salt and fat intake), correct medication use, physical activity suitable to cardiac status, and stress management. Training in effective communication skills, managing negative emotions, and correcting negative disease-related thoughts (such as “my disease is incurable”) will also be conducted. This session will also include a Q&A addressing patients’ uncertainties and daily experiences in disease management.Session 3:This session will review previous sessions and assess patients’ understanding of the disease and behavioral changes. Education on coping strategies for stress, anxiety, and depressive symptoms, psychological consequences of the disease, the importance of continuous medication adherence, and regular medical follow-up will be provided. Barriers and challenges to treatment adherence and self-care will be identified and practical solutions offered. At the end of this session, a comprehensive educational brochure containing information about the disease, diet, exercise, medication, warning signs, stressors, and their management will be given to the intervention group patients. To uphold ethical principles, this brochure will also be provided to the control group patients after the study is completed.Follow-up:Patients will be evaluated at three time points: immediately after hospital discharge, one month after discharge, and three months after discharge through telephone calls and in-person visits at the clinic. The health literacy and treatment adherence questionnaires will be re-administered at each stage.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2025-07-08, 1404/04/17
Ethics committee reference number
IR.QUMS.REC.1404.115
Health conditions studied
1
Description of health condition studied
Patients with heart failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Health literacy
Timepoint
"Before the intervention, one month after the intervention, three months after the intervention."
Method of measurement
Health literacy questionnaire
2
Description
Adherence
Timepoint
"Before the intervention, one month after the intervention, three months after the intervention."
Method of measurement
Heart Failure Adherence Questionnaire
Secondary outcomes
1
Description
Illness perception
Timepoint
"Before the intervention, one month after the intervention, three months after the intervention."
Method of measurement
Illness perception questionnaire
Intervention groups
1
Description
Intervention group: , in addition to routine care, will receive an educational intervention based on Leventhal’s self-regulation model, delivered individually and face-to-face during three sessions of 30 to 40 minutes each during hospitalizationEducational Sessions:Session 1:The content focuses on enhancing patients’ understanding of the disease, including explanations about the nature of heart failure, symptoms (shortness of breath, limb swelling, weakness, fatigue), causes (hypertension, coronary artery disease, valvular disease), disease progression, short- and long-term consequences (frequent hospitalizations, functional limitations), and the possibility of disease control through appropriate treatment. Misconceptions held by patients will also be identified and corrected. Techniques such as feedback provision, concrete examples, sharing experiences of successful patients, and short-term goal setting (e.g., weight loss, blood pressure control) will be employed.Session 2:After reviewing the content of the first session, this session emphasizes self-care aspects including adherence to an appropriate diet (reducing salt and fat intake), correct medication use, physical activity suitable to cardiac status, and stress management. Training in effective communication skills, managing negative emotions, and correcting negative disease-related thoughts (such as “my disease is incurable”) will also be conducted. This session will also include a Q&A addressing patients’ uncertainties and daily experiences in disease management.Session 3:This session will review previous sessions and assess patients’ understanding of the disease and behavioral changes. Education on coping strategies for stress, anxiety, and depressive symptoms, psychological consequences of the disease, the importance of continuous medication adherence, and regular medical follow-up will be provided. Barriers and challenges to treatment adherence and self-care will be identified and practical solutions offered. At the end of this session, a comprehensive educational brochure containing information about the disease, diet, exercise, medication, warning signs, stressors, and their management will be given to the intervention group patients. To uphold ethical principles, this brochure will also be provided to the control group patients after the study is completed.
Category
Behavior
2
Description
Control group: receive routine care training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Social Security Hospitals of Qazvin
Full name of responsible person
Atefeh Alizadeh risani
Street address
Qazvin, Shahid Babaei Blvd
City
Qazvin
Province
Qazvin
Postal code
3413685931
Phone
+98 28 3366 5009
Fax
+98 28 3366 5009
Email
info@qazvin.tamin.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Ali Soleimani
Street address
Qazvin University of Medical Sciences, Bahonar Blvd. Qazvin
City
Qazvin
Province
Qazvin
Postal code
کد پستی : 15315-3419
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Atefeh Alizadeh risani
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd. Qazvin
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
atefehalizaddeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Ali Soleimani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd. Qazvin
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
soleimany.msn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Atefeh Alizadeh risani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd. Qazvin
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
atefehalizaddeh@yahoo.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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Complete data are shareable after proper anonymization procedures.
When the data will become available and for how long
Following the publication of the main study results