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IRCT20231204060260N1 IRCT 2024-01-24 Shahid Beheshti University of Medical Sciences Effect of Need-Based Education on Clinical Outcomes in Patients The effect of Need-Based Education on Clinical Outcomes in Patients under treatment with Direct oral anticoagulants (DOACs) drugs in Hospital Affiliated to Shiraz University of Medical Sciences 2024-01-21 anticipated 92 Complete https://irct.ir/trial/74256 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method will initially be convenience; The samples will then be placed in quadruple blocks by block random sampling. The blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment, we will have 4 blocks (including 2 participants in the intervention group and 3 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed. N/A Patients treated with Oral Anticoagulation Drug. Intervention 1: Intervention group: For the intervention group, basic and advanced trainings will be implemented based on the need and according to the results of the score obtained from the knowledge questionnaire of anticoagulant drugs. These trainings are related to the time to see a doctor, INR level check periods, the time to apply activity restrictions and the time to return to daily activities, drug side effects, self-care, patients' awareness of the drug, and factors affecting the treatment process with the help of pamphlets and face-to-face training on the interview day. In the second and fourth week, the applicants will receive training by phone. Intervention 2: Control group: will receive only usual training and 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 further information
public Fariba Bakhshayesh
Valiasr St., Niayesh Highway Intersection, Opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 faribabakhshayesh815@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahsa Boozaripoor
Valiasr St., Niayesh Highway Intersection, Opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 emettis@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being between 18 and 80 years old Receiving oral anticoagulants The client's ability to learn the instructions and perform the self-care process 18 years 80 years Both Presence of active bleeding The presence of mental illnesses and the use of psychotropic drugs according to the patient's statement T45.61 Poisoning by, adverse effect of and underdosing of thrombolytic drugs Other N/A Intervention group: For the intervention group, basic and advanced trainings will be implemented based on the need and according to the results of the score obtained from the knowledge questionnaire of anticoagulant drugs. These trainings are related to the time to see a doctor, INR level check periods, the time to apply activity restrictions and the time to return to daily activities, drug side effects, self-care, patients' awareness of the drug, and factors affecting the treatment process with the help of pamphlets and face-to-face training on the interview day. In the second and fourth week, the applicants will receive training by phone. Control group: will receive only usual training and care. Prothrombin Time and International Normalized Ratio (PT/INR). Timepoint: Before and six weeks after the intervention. Method of measurement: Blood test. Medication Adherences. Timepoint: Before and one month after the intervention. Method of measurement: Moriski medication adherence questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-11-13 Ethics committee of Shahid Beheshti University of Medical Sciences Valiasr St., Niayesh Highway Intersection, Opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)