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IRCT20240304061168N1 IRCT 2024-05-21 Hamedan University of Medical Sciences The effect of e-health education on patients with heart failure The effect of e-health education based on the therapeutic engagement model on the health and behavioral outcomes of patients with heart failure 2024-05-21 anticipated 88 Complete https://irct.ir/trial/75825 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, among the patients who meet the inclusion criteria, they will be selected using the available sampling method and based on the random block method, they will be assigned to either the e-health education group based on the therapeutic engagement model (intervention) or the group receiving routine training (control). For this purpose, the researcher will prepare 4 sheets, with the number "1" written on two sheets for the first group and the number "2" written on two sheets for the second group. The cards will be mixed in a container and randomly drawn one at a time for each patient without replacement until all four cards are drawn. Then four sheets will be returned to the container, and this process will be repeated until the calculated sample volume is reached, Blinding description: The statistical analysis and outcome assessment will not know about the assignment of patients to two intervention and control groups during the analysis. N/A Patients with heart failure. Intervention 1: Intervention group: After introducing the study and stating its objectives, if desired, the patients will complete the informed consent form, the demographic information form, self-care of heart failure index, medication adherence reporting scale, rapid assessment of physical activity, and MacNew questionnaires. In addition to receiving routine training during discharge that is provided in the hospital, patients will benefit from an educational website about heart failure developed by the research team. Participants in the intervention group are given usernames and passwords specific to each of them, and basic training is provided on how to use each of the website's components. The website will be provided to the intervention group for three months and they will benefit from its educational content by using the website. Different sections of the website include educational modules related to understanding heart failure, the causes and complications of this disease, services that can be provided by the relevant doctor or nurse, self-efficacy and self-management training for the patient, lifestyle modification, the section related to caregivers, warning signs and questions that can be exchanged with the doctor, simple language animations for better visual understanding by patients of the condition, interviews with various patients going through different stages of treatment, practical tools for increasing self-efficacy and adherence to treatment including symptoms and events diary, monitoring chart, appointment record, warning signs, and medicine chart as well as a section for patient question and answer. To follow up and motivate the patients in the intervention group, phone calls will be made to them once a week in the first month and once every two weeks in the next two months. Also, patients can ask the researcher through the website whenever they have a question. The study outcomes will be assessed through questionnaires at pre-study and 3 months after the end of the intervention. Intervention 2: Control group: In this group, patients will enter the study after receiving informed consent and will complete the questionnaires. These people will only undergo routine training during hospital discharge and will not receive e-health education. At the end of the study, the educational content of the website will be provided to this group in the form of a booklet. The study outcomes will be assessed through questionnaires at pre-study and 3 months after the end of the intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is I must provide all information for the sponsoring institution
public Mohammad Reza Ghorbani
Shahid Fahmideh Blvd., Pajouhesh Sq.
Hamedan Iran (Islamic Republic of) 6517838698 +98 81 3838 0535 mohammad.r.gh.11382@gmail.com Hamedan University of Medical Sciences scientific Fatemeh Pakrad
Shahid Fahmideh Blvd., Pajouhesh Sq.
Hamedan Iran (Islamic Republic of) 6517838698 +98 81 3838 0535 f_pakrad@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of heart failure class I to III confirmed by a cardiologist Reading and writing literacy Over 18 years of age Desire to participate in the study Internet access by patient or a family member who lives with patient Absence of psychiatric diseases Having heart failure for at least 6 months 18 years no limit Both Having severe emergency conditions Patient refusal to continue the study Patient’s death Participation in other educational programs I50 Heart failure Treatment - Other Treatment - Other Intervention group: After introducing the study and stating its objectives, if desired, the patients will complete the informed consent form, the demographic information form, self-care of heart failure index, medication adherence reporting scale, rapid assessment of physical activity, and MacNew questionnaires. In addition to receiving routine training during discharge that is provided in the hospital, patients will benefit from an educational website about heart failure developed by the research team. Participants in the intervention group are given usernames and passwords specific to each of them, and basic training is provided on how to use each of the website's components. The website will be provided to the intervention group for three months and they will benefit from its educational content by using the website. Different sections of the website include educational modules related to understanding heart failure, the causes and complications of this disease, services that can be provided by the relevant doctor or nurse, self-efficacy and self-management training for the patient, lifestyle modification, the section related to caregivers, warning signs and questions that can be exchanged with the doctor, simple language animations for better visual understanding by patients of the condition, interviews with various patients going through different stages of treatment, practical tools for increasing self-efficacy and adherence to treatment including symptoms and events diary, monitoring chart, appointment record, warning signs, and medicine chart as well as a section for patient question and answer. To follow up and motivate the patients in the intervention group, phone calls will be made to them once a week in the first month and once every two weeks in the next two months. Also, patients can ask the researcher through the website whenever they have a question. The study outcomes will be assessed through questionnaires at pre-study and 3 months after the end of the intervention. Control group: In this group, patients will enter the study after receiving informed consent and will complete the questionnaires. These people will only undergo routine training during hospital discharge and will not receive e-health education. At the end of the study, the educational content of the website will be provided to this group in the form of a booklet. The study outcomes will be assessed through questionnaires at pre-study and 3 months after the end of the intervention. Self-care. Timepoint: Before and 3 months after the end of the intervention. Method of measurement: Using the self-care of heart failure index by Riegel et alia: The self-care of heart failure index was designed and compiled by Riegel et alia in 2004 to measure the self-care in heart failure patients. This questionnaire consists of 3 scales with 22 questions, including 10 questions for self-care maintenance, 6 questions for self-care management, and 6 questions for self-care confidence. Each scale is standardized with a possible score from 0 to 100. Medication adherence. Timepoint: Before and 3 months after the end of the intervention. Method of measurement: Using the medication adherence reporting scale by Yan Chen et alia: The medication adherence reporting scale was compiled by Yan Chen et alia in 2019. This questionnaire contains of 5 questions, and the frequency rating of each behavior in this questionnaire is based on a 5-point scale that is graded from never to always. The total score of the scale ranges from 5, which indicates the lowest level of adherence, to 25, which indicates the highest level of adherence. Physical activity. Timepoint: Before and 3 months after the end of the intervention. Method of measurement: Using the rapid assessment of physical activity questionnaire by Topolski et alia: The rapid assessment of physical activity questionnaire was compiled by Topolski et alia in 2006 in order to measure the physical activity. This questionnaire contains of 9 questions designed to evaluate strength, flexibility and level and intensity of physical activity. The total score of the first seven items is from 1 to 7 points, with the respondent's score categorized into one of five levels of physical activity: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active. Responses to the strength training and flexibility items are scored separately, with strength training = 1, flexibility = 2, or both = 3. Health related quality of life. Timepoint: Before and 3 months after the end of the intervention. Method of measurement: Using the MacNew Heart Disease health-related quality of life questionnaire by Valenti et alia: The MacNew Heart Disease health-related quality of life questionnaire was designed and compiled by Valenti et alia in 1996. This questionnaire consists of 27 items which fall into three domains [a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale]. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The maximum possible score in any domain is 7 [high HRQL] and the minimum is 1 [poor HRQL]. Hamedan University of Medical Sciences Approved 2024-05-11 Hamedan University of Medical Sciences Shahid Fahmideh Blvd., Pajouhesh Sq. Hamedan Hamadan Iran (Islamic Republic of)