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IRCT20200922048806N1 IRCT 2021-03-30 Tehran University of Medical Sciences The effect of an Education on treatment adherence and readmition in Patients with heart failure The effect of an Educational Intervention Based on PRECEDE – PROCEED Model on treatment adherence and readmition rate among Patients with heart failure 2021-03-05 anticipated 72 Complete https://irct.ir/trial/51489 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A total of 72 samples are selected based on the inclusion criteria and by convenience sampling method, and are allocated to the control and intervention groups using block random allocation method.. Depending on the sample size, 18 blocks of 4 are required for random block allocation. The intervention group will be displayed with A and the control group with B. Samples can be placed in blocks in 6 different modes. The website https://www.Randomization.com will be used to determine the random sequence of blocks. In order to allocation concealment from the researcher, 72 dark envelopes were prepared and each of the random sequences created was recorded on a card and placed inside the envelope, and finally the envelope lid was pasted. At the beginning of the registration of individuals, according to the order of arrival of the samples, one of the envelopes is opened in order and the assigned group of that sample is specified. N/A Heart Failure. Intervention 1: Intervention group: The educational intervention is designed based on the third phase of the Precede- Proceed Model, educational assessment, among the predisposing, enabling, and reinforcing constructs. Then, impact evaluation is carried out to examine the immediate effect of the program, including therapy adherence and readmission. Predisposing factors include the knowledge, attitudes, and beliefs of the affected person. Two 60-minute face-to-face sessions will be held to promote patients' awareness. In the first training session, we will discuss the following themes: familiarity of patients with adherence to treatment and medication, their knowledge about the benefits of treatment adherence and how to use medication, the definition of adherence to medication and therapy, and factors affecting these variables, appropriate dietary and lifestyle changes in heart failure according to the existing recommendations, and approaches to control these variables. There will be two 60-minute discussion sessions to assess patients' attitudes and provide the researcher's opinion to the participants. Reinforcing factors in this study include encouragement from the spouse or a family member (a key figure in a person's life). A 60-minute face-to-face meeting will be held with the key person to discuss the family's role in the disease process, encouragement strategies, and methods to motivate the patient. The enabling factors include two 60-minute training sessions to discuss the role of mass media in treatment adherence and the importance of quality of life improvement. Also, the authors will use a virtual social network. Finally, there will be a session to review the issues and resolve the problems and any ambiguities. Researchers will use PowerPoint slides and educational posters in all sessions. The intervention is performed for the experimental group in a month (two sessions per week). During this time, the intervention group will join a virtual educational channel, and the educational materials will be shared in this channel. Before and after the intervention, a demographic questionnaire, the Madanloo treatment adherence questionnaire, and a researcher-made readmission inventory will be completed. Post-test will be conducted one and three months after training, respectively. Intervention 2: Control group: The control group will not receive any intervention and receive routine care. 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 There is no more information
public Fereshte Eskandari
Emam khomaini Hospital., Sepah ave., Parastar Blvd., Dehdasht., Yasouj
Dehdasht Iran (Islamic Republic of) 7571888655 +98 74 3226 5904 8238fereshte.eskandari@gmail.com Tehran University of Medical Sciences scientific Shahrzad Pashahipour
School of Nursing Midwifery ,Tehran University of Medical Sciences., Nosrat st., Tohid sq., TEHRAN., IRAN
Theran Iran (Islamic Republic of) 1419733171 +98 21 6105 4142 sh-pashaeipour@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) History of hospitalization at least once Have at least one year of heart failure Have Class II (mild) and III (moderate) heart failure based on the New York Heart Association classification scale and specialist physician approval Age over 50 years Minimum literacy Living with family The ability to use smartphones 50 years no limit Both Having psychological illnesses Chronic diseases other than hypertension and diabetes I50 Heart failure Lifestyle Other Intervention group: The educational intervention is designed based on the third phase of the Precede- Proceed Model, educational assessment, among the predisposing, enabling, and reinforcing constructs. Then, impact evaluation is carried out to examine the immediate effect of the program, including therapy adherence and readmission. Predisposing factors include the knowledge, attitudes, and beliefs of the affected person. Two 60-minute face-to-face sessions will be held to promote patients' awareness. In the first training session, we will discuss the following themes: familiarity of patients with adherence to treatment and medication, their knowledge about the benefits of treatment adherence and how to use medication, the definition of adherence to medication and therapy, and factors affecting these variables, appropriate dietary and lifestyle changes in heart failure according to the existing recommendations, and approaches to control these variables. There will be two 60-minute discussion sessions to assess patients' attitudes and provide the researcher's opinion to the participants. Reinforcing factors in this study include encouragement from the spouse or a family member (a key figure in a person's life). A 60-minute face-to-face meeting will be held with the key person to discuss the family's role in the disease process, encouragement strategies, and methods to motivate the patient. The enabling factors include two 60-minute training sessions to discuss the role of mass media in treatment adherence and the importance of quality of life improvement. Also, the authors will use a virtual social network. Finally, there will be a session to review the issues and resolve the problems and any ambiguities. Researchers will use PowerPoint slides and educational posters in all sessions. The intervention is performed for the experimental group in a month (two sessions per week). During this time, the intervention group will join a virtual educational channel, and the educational materials will be shared in this channel. Before and after the intervention, a demographic questionnaire, the Madanloo treatment adherence questionnaire, and a researcher-made readmission inventory will be completed. Post-test will be conducted one and three months after training, respectively. Control group: The control group will not receive any intervention and receive routine care. Score of treatment adherence in madanloo questionnaire. Timepoint: Before study, One month after study and Three month after study. Method of measurement: Madanloo treatment adherence questionnaire. Percentage of people with readmission. Timepoint: One month after study and Three month after study. Method of measurement: Researcher-made questionnaire on readmission rate. Tehran University of Medical Sciences Approved 2020-09-07 Ethics Committee of the School of Nursing and Midwifery and the School of Rehabilitation, Tehran Uni Tehran University of Medical Sciences., ghods Ave., Keshavarz BLvd., Tehran Tehran Tehran Iran (Islamic Republic of)