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IRCT20210714051889N1 IRCT 2023-03-11 Shahid Beheshti University of Medical Sciences The Effect of Smartphone-Based Educational Program on Self-Efficacy of Patients Undergoing Heart Valve Surgery and the Family Caregivers' Burden The Effect of Smartphone-Based Educational Program on Self-Efficacy of Patients Undergoing Heart Valve Surgery and the Family Caregivers' Burden: Parallel Randomized Clinical Trial 2023-01-30 anticipated 60 Complete https://irct.ir/trial/68216 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done by block method. First, the random allocation sequence and block list will be obtained by the statistical consultant. The website https://www.sealedenvelope.com is used to generate a random sequence for block-type randomization so that there is no limit on the number of blocks for random allocation. In this research, the block method with a volume of 4 is used to create a random allocation sequence. According to the total number of samples required for the study, which was 60 family members and patients (30 patients and family members in the test group (A) and 30 family members and patients in the control group (B)), in 15 quadruple blocks including Two groups A and B will be randomly selected through the site. Based on the list of randomized blocks of four prepared, a trained nursing expert outside the research group is responsible for registering participants and assigning patients randomly, after the entry of each patient, according to the 15 blocks of four prepared in the first stage, each patient is Randomly placed in group A (intervention) or B (control group). For example, after randomly selecting the BBAB block, the patients were placed in the control, control, intervention and control groups in the order of their entry. And the sampling process is done consecutively in the same way until the sampling is completed, and the code of each patient was also assigned to his family member. People are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks. N/A of Patients Undergoing Heart Valve Surgery. Intervention 1: Intervention group: The intervention is in the form of providing an application (Android application) that can be installed on the phone, which provides information about heart valve failure and dysfunction, familiarity with drugs and the necessity of using them, the importance of the role of self-efficacy in the patient, and the beneficial effects of self-care and emphasis. on the importance of the role of caregivers and reducing the burden of care and how to take proper care of oneself and its dimensions and the importance of how to manage symptoms and signs in emergency situations and the importance of making changes in lifestyle for the patient and caregiver (including following a proper diet, mobility and exercise, It includes medication adherence, smoking cessation, weight control) and other educational information. The smartphone-based application is installed by the researcher for the patient and caregiver in the intervention group, and a session is taught on how to use the application (in order to prevent access to the application by the control group during the intervention, a special password is required to enter the program given to a phone). At the same time, the intervention group will use the routine training programs of the heart clinic. During the implementation of the intervention until the re-completion of the questionnaires, the researcher was in contact with the caregivers and the patient through telephone calls and questions and answers with the participants through the formation of a group in the available social network (if the participants are satisfied). And while following up by phone, their questions will be answered. After 8 weeks from the end of the intervention, the questionnaires will be given to the intervention group again. Intervention 2: Control group: At the same time, the control group will benefit from the clinic's routine training in the form of face-to-face training and hospital pamphlets. The relevant questionnaires are designed face-to-face or press-line and are completed by the research sample (including the patient and his caregiver) and face-to-face training sessions are arranged in one to two sessions according to the needs of the individual and then to answer questions no. The phone will be provided to them. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The significance level of the study is not yet known, and it will be concluded after a complete study.
public MOHAMMAD ZAREI
No. 12, Unit 1, 2 Moghadam Alley, Shahid Ali Mazaheri Alley, South Rodaki St., Tehran
tehran Iran (Islamic Republic of) 1346756168 +98 21 2624 4174 zarei .mohammad72@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Neda Sanaie
Tehran, Wali Asr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery
tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 nedasanaie@ymail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The age range of people should be between 18 and 65 years. Have an Android smartphone. Patients undergo mechanical valve surgery for the first time. 18 years 65 years Both Suffering from known physical and mental diseases that affect the quality of life, such as dialysis, or other known mental problems, such as depression and schizophrenia, which require special medication or diet (according to the patient's self-report). People who have participated in another educational program during the research. People who have hearing, visual and touch disorders or who are not able to speak Persian language. People who underwent valve repair or biological valve. Other Other Intervention group: The intervention is in the form of providing an application (Android application) that can be installed on the phone, which provides information about heart valve failure and dysfunction, familiarity with drugs and the necessity of using them, the importance of the role of self-efficacy in the patient, and the beneficial effects of self-care and emphasis. on the importance of the role of caregivers and reducing the burden of care and how to take proper care of oneself and its dimensions and the importance of how to manage symptoms and signs in emergency situations and the importance of making changes in lifestyle for the patient and caregiver (including following a proper diet, mobility and exercise, It includes medication adherence, smoking cessation, weight control) and other educational information. The smartphone-based application is installed by the researcher for the patient and caregiver in the intervention group, and a session is taught on how to use the application (in order to prevent access to the application by the control group during the intervention, a special password is required to enter the program given to a phone). At the same time, the intervention group will use the routine training programs of the heart clinic. During the implementation of the intervention until the re-completion of the questionnaires, the researcher was in contact with the caregivers and the patient through telephone calls and questions and answers with the participants through the formation of a group in the available social network (if the participants are satisfied). And while following up by phone, their questions will be answered. After 8 weeks from the end of the intervention, the questionnaires will be given to the intervention group again. Control group: At the same time, the control group will benefit from the clinic's routine training in the form of face-to-face training and hospital pamphlets. The relevant questionnaires are designed face-to-face or press-line and are completed by the research sample (including the patient and his caregiver) and face-to-face training sessions are arranged in one to two sessions according to the needs of the individual and then to answer questions no. The phone will be provided to them. Self-efficacy of patients undergoing heart valve surgery. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: Patient's demographic information questionnaire and Sullivan Cardiac Self-Efficacy Questionnaire (SCSES) are completed by the patient. Sullivan's self-efficacy questionnaire has 16 questions, which evaluates the level of confidence and self-efficacy of patients in the field of compliance with general care, control of disease symptoms, and compliance with medication orders. The questionnaire is scored on a 5-point Likert scale, including completely = 4, very much = 3, almost = 2, a little = 1 to not at all = 0. Caring burden of family caregivers. Timepoint: Before the intervention and eight weeks after the intervention. Method of measurement: The caregiver demographic information questionnaire and the CBI care burden questionnaire are completed by the caregiver. The care burden questionnaire has 24 statements, which was created in 1989 by Novak and Guest to measure the objective and mental burden of care and measures the burden of mental care with more emphasis. This questionnaire has five subscales and includes time-dependent caregiving burden, evolutionary caregiving burden, physical caregiving burden, social caregiving burden, and emotional caregiving burden. ), it measures partially correct (score 2), correct (score 3) and completely correct (score 4), therefore, the scores obtained from this questionnaire are from zero to 96. Shahid Beheshti University of Medical Sciences Approved 2022-10-31 Ethics committee in research of the Faculties of Pharmacy, Nursing and Midwifery, Shahid Beheshti Un Resalat Highway, Kerman Street, Shahid Mousavi Street tehran Tehran Iran (Islamic Republic of)