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IRCT20250713066474N1 IRCT 2025-07-24 Qazvin University of Medical Sciences Investigating the effect of Leventhal's self-regulation model on health literacy and adherence in heart failure - 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 2025-09-21 anticipated 92 Complete https://irct.ir/trial/84940 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, 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, 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. N/A Patients with heart failure. Intervention 1: 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. Intervention 2: Control group: receive routine care training. Yes - There is a plan to make this available What will be shared: Complete data are shareable after proper anonymization procedures. When: Following the publication of the main study results To whom: Academic and research institution scholars Conditions: - Where to obtain: Atefeh Alizadeh risani email: atefehalizaddeh@yahoo.com How to obtain: Request via email - Typically responded to within approximately 10 days. Comments: -
public Atefeh Alizadeh risani
Qazvin University of Medical Sciences, Bahonar Blvd. Qazvin
Qazvin Iran (Islamic Republic of) 15315-34199 +98 28 3333 6001 atefehalizaddeh@yahoo.com Qazvin University of Medical Sciences scientific Mohammad Ali Soleimani
Qazvin University of Medical Sciences, Bahonar Blvd. Qazvin
Qazvin Iran (Islamic Republic of) 15315-34199 +98 28 3333 6001 soleimany.msn@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both 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 Behavior N/A 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. Control group: receive routine care training Health literacy. Timepoint: "Before the intervention, one month after the intervention, three months after the intervention.". Method of measurement: Health literacy questionnaire. Adherence. Timepoint: "Before the intervention, one month after the intervention, three months after the intervention.". Method of measurement: Heart Failure Adherence Questionnaire. Illness perception. Timepoint: "Before the intervention, one month after the intervention, three months after the intervention.". Method of measurement: Illness perception questionnaire. Qazvin University of Medical Sciences Approved 2025-07-08 Ethics committee of qazvin University of Medical Sciences Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin qazvin Qazvin Iran (Islamic Republic of)