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IRCT20230216057433N1 IRCT 2023-04-10 Iran University of Medical Sciences The effect of family-centered education on adherence to medication regimen in patients with cardiomyopathy Investigating the effect of family-centered education on adherence to medication regimen in patients with cardiomyopathy 2023-04-09 anticipated 80 Complete https://irct.ir/trial/68735 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Available sampling in the form of block random allocation. Considering that in this study we have two groups including an intervention group and a control group, the size of the blocks will be twice the number of groups, i.e. 4, and the number of blocks obtained will be 6 blocks (AABB, ABAB, ABBA, BBAA BABA, BAAB). First, one of the numbers of the blocks is randomly selected by the statistical software, and then the samples will be assigned to the corresponding group based on the order of placement in each block. In the block, patients will enter one of the intervention and control groups (intervention = A, control = B). This work will continue until the number of samples is completed. N/A Condition 1: Cardiomyopathy. Condition 2: Adherence to medication regimen. Condition 3: Family-centered education. Intervention 1: Intervention group: In the intervention group, the patient must attend the meetings together with a fixed member designated by the patient.Due to the physical condition of the patients and the inability to tolerate multiple visits, according to the doctor's opinion, the trainings are held in 2 half-hour sessions in groups of 4-6 people using a combination of educational methods in the form of showing a voiced video containing text and images and providing an educational pamphlet. And a short speech will be made. The educational content in the first session includes: Familiarity with cardiomyopathy, how to control vital signs, the importance of following the medication regimen and accurate medication use, and in the second session: Familiarity with important medications in cardiomyopathy and how to take care and precautions in using the patient's medications, drug side effects and their management.In the last session, the contact number of the patient and the active member will be obtained to coordinate for the evaluation after the intervention. Due to the fact that it is difficult for the participants to visit in person after the intervention due to their illness or age, and in addition, the time of the next visit for the visit is not the same for all patients, in order to maintain the consistency of the examination time after 4 weeks of the intervention. According to the opinion of the relevant FLO), first, the electronic form of the questionnaire will be sent to the contact number or email address of the patient or active family member and will be reminded to complete the questionnaire during a phone call. After receiving the completed form of the questionnaires, the collected data will be entered into the SPSS software It will be 16.The data will be analyzed with appropriate statistical tests. Control group: The training in the control group will be with the routine training of the hospital. This group will complete the questionnaire twice, once before and once after 4 weeks of receiving the routine training of the hospital. Intervention 2: Control group: The control group consists of 40 people in the study, who entered this group by random allocation method of block type, and completed the Morisky medication adherence questionnaire by them, twice, without providing family-centerd education and only with providing routine and usual training will be done during the period of 4 weeks. Yes - There is a plan to make this available What will be shared: Data related to the disease and medication compliance before and after the intervention will be shared. When: Access starts 3 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: There is no limitation in performing statistical analysis on the data of this study. Researchers can use the data as a reference in their studies, mainly in the description of existing conditions. Where to obtain: Applicants can contact the following email address to receive the data. fn.kheirkhah@gmail.com How to obtain: Honorable applicants must send along with their application, the purpose of the data request, the title of their research work and the code of research ethics for which they need the data of the present study. After checking the title and confirming the code of ethics, the data will be sent to the applicant's email address as soon as possible. Comments:
public Fatemeh kheirkhah
No 8, East 9th Ave, Salehi St, Laleh Blvd, Tehransar
Tehran Iran (Islamic Republic of) 1387977338 +98 21 4451 0300 fn.kheirkhah@gmail.com Iran University of Medical Sciences scientific Fatemeh Kheirkhah
No 8, East 9th Ave, Salehi St, Laleh Blvd, Tehransar
Tehran Iran (Islamic Republic of) 1387977338 +98 21 4451 0300 fn.kheirkhah@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) • Doctor's confirmation for the patient in terms of having cardiomyopathy• with symptoms classified as class II or higher heart failure, with a left ventricular ejection fraction of 45% or less • Absence of diagnosed psychological illness, • Having a minimum of 18 and a maximum of 65 years to enter the study for both the patient and the family member • Residence in Tehran or the possibility of staying in Tehran for at least one week if you are a traveler, in order to be able to attend training sessions • Failure to simultaneously participate in other similar researches, • Being literate in reading and writing for both the patient and the family member • Access to a smartphone and the ability to work with a smartphone (for the patient or an active caregiver) to follow up • Residence of an active family member in the patient's place of residence or close to him • The possibility of making a phone call with the patient or an active family member 18 years 65 years Both Patients who do not have sufficient physical and mental capacity to participate in the study or who have a severe and critical illness. I42.9 Cardiomyopathy, unspecified Lifestyle Lifestyle Intervention group: In the intervention group, the patient must attend the meetings together with a fixed member designated by the patient.Due to the physical condition of the patients and the inability to tolerate multiple visits, according to the doctor's opinion, the trainings are held in 2 half-hour sessions in groups of 4-6 people using a combination of educational methods in the form of showing a voiced video containing text and images and providing an educational pamphlet. And a short speech will be made. The educational content in the first session includes: Familiarity with cardiomyopathy, how to control vital signs, the importance of following the medication regimen and accurate medication use, and in the second session: Familiarity with important medications in cardiomyopathy and how to take care and precautions in using the patient's medications, drug side effects and their management.In the last session, the contact number of the patient and the active member will be obtained to coordinate for the evaluation after the intervention. Due to the fact that it is difficult for the participants to visit in person after the intervention due to their illness or age, and in addition, the time of the next visit for the visit is not the same for all patients, in order to maintain the consistency of the examination time after 4 weeks of the intervention. According to the opinion of the relevant FLO), first, the electronic form of the questionnaire will be sent to the contact number or email address of the patient or active family member and will be reminded to complete the questionnaire during a phone call. After receiving the completed form of the questionnaires, the collected data will be entered into the SPSS software It will be 16.The data will be analyzed with appropriate statistical tests. Control group: The training in the control group will be with the routine training of the hospital. This group will complete the questionnaire twice, once before and once after 4 weeks of receiving the routine training of the hospital. Control group: The control group consists of 40 people in the study, who entered this group by random allocation method of block type, and completed the Morisky medication adherence questionnaire by them, twice, without providing family-centerd education and only with providing routine and usual training will be done during the period of 4 weeks. The degree of adherence with the medication regimen. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: The way to measure the variable in this study is Morisky's 8-question medication adherence questionnaire, which includes 6 yes/no questions and one question with a likert scale from never to always. Iran University of Medical Sciences Approved 2023-02-22 Ethics Committee of Iran University of Medical Sciences No 8, East 9th Ave, Salehi St, Laleh Blvd, Tehransar Tehran Tehran Iran (Islamic Republic of)