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IRCT20170923036337N2 IRCT 2018-02-02 Vice chancellor for research of Tehran University of Medical Sciences The Effect of Continuous Care Model On the Bone Marrow Transplantation Complications The effect of continuing care model on complications of bone marrow transplantation in patients undergoing bone marrow transplantation 2017-07-23 anticipated 104 Complete https://irct.ir/trial/27199 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: In this study, the method used to generate random sequences of patients in the control and case groups is done by stratified randomization. Randomizing at the individual level. By categorizing effective variables such as age, gender, type of transplant, etc., before random assignment, we try to eliminate heterogeneity in groups. Then each randomization class is based on blocking. Allocating patients in the two groups will done randomly on the basis of double blocks. Sequence according to the number of samples in each group, in general 26 blocks. Method of allocation concealment is Central randomization. 3 Condition 1: aplastic anaemia. Condition 2: Multiple myeloma. Condition 3: Hodgkin lymphoma. Condition 4: non-Hodgkin lymphoma. Condition 5: Lymphoblastic leukemia. Condition 6: Myeloblastic leukemia. Intervention 1: In the intervention group: In this intervention study, a continuous care model was used to educate patients undergoing stem cell transplantation. After collecting information at the first time (in the clinic) for each patient, based on the Inclusion criteria, they will be inter the study from the first day of admission for transplantation. Patient in the case group, in addition to routine care and training, will receive training based on a continuous care model, which is a native care model with specific continuity and coherence, for 3 months. During 3 individual and face-to-face sessions, this group will receive a training booklet includes training bone marrow and stem cell transplantation, chemotherapy, Complications of chemotherapy, recommendations for the prevention and control of chemotherapy complications, post-bone marrow transplant care and post- Stem cells transplant interventions to transplant patients. The researcher uses the framework of a continuous care model that includes the stages of Orientation, sensitization, control and evaluation. In the Orientation stage, new care issues are identified, categorized and reviewed. In the second phase, individually continuous training is provided on improving nutrition, relieving the symptoms and complications of GVHD, controlling infection, reducing the number of admission days and anxiety control. And in the third step, by consulting and referring patients for a visit, their questions will be answered and a booklet containing the training will be given to them. In the fourth stage, by phone or face to face, the implementation of the care model plan is followed up. Follow-Up times are in the first month, the second month and then the third month after transplantation. At this time, the questionnaires are completed again and their information is compared. Intervention 2: In the control group: Patients will receive the same routine care and routine training by nurses in the transplant department, just in the same hospital stay. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet.The release plan is still unknown
public Fatemeh Esmaielzadeh
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid square, Tehran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 fatemah.esmaielzadeh@yahoo.com Faculty of Nursing and Midwifery, Tehran University of Medical Sciences scientific Dr Shahrzad Ghiyasvandiyan
Central building of Tehran University of Medical Sciences, ghods street, Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 shghiyas@tums.ac.ir Faculty of Nursing and Midwifery, Tehran University of Medical Sciences Iran (Islamic Republic of) Have at least reading and writing skills, Age between 15 and 60 years, Lack of verbal and perceptual and psychological disorders The patient should not be simultaneously in another study 15 years 60 years Both The patient is a member of the treatment team, Incidence of intense complications after bone marrow transplantation Relapse of disease Death of Patient D61 C90 C81 C85 C91 C92 Other aplastic anaemias Multiple myeloma Hodgkin lymphoma Other and unspecified types of non-Hodgkin lymphoma Lymphoid leukaemia Myeloid leukaemia Other Other In the intervention group: In this intervention study, a continuous care model was used to educate patients undergoing stem cell transplantation. After collecting information at the first time (in the clinic) for each patient, based on the Inclusion criteria, they will be inter the study from the first day of admission for transplantation. Patient in the case group, in addition to routine care and training, will receive training based on a continuous care model, which is a native care model with specific continuity and coherence, for 3 months. During 3 individual and face-to-face sessions, this group will receive a training booklet includes training bone marrow and stem cell transplantation, chemotherapy, Complications of chemotherapy, recommendations for the prevention and control of chemotherapy complications, post-bone marrow transplant care and post- Stem cells transplant interventions to transplant patients. The researcher uses the framework of a continuous care model that includes the stages of Orientation, sensitization, control and evaluation. In the Orientation stage, new care issues are identified, categorized and reviewed. In the second phase, individually continuous training is provided on improving nutrition, relieving the symptoms and complications of GVHD, controlling infection, reducing the number of admission days and anxiety control. And in the third step, by consulting and referring patients for a visit, their questions will be answered and a booklet containing the training will be given to them. In the fourth stage, by phone or face to face, the implementation of the care model plan is followed up. Follow-Up times are in the first month, the second month and then the third month after transplantation. At this time, the questionnaires are completed again and their information is compared. In the control group: Patients will receive the same routine care and routine training by nurses in the transplant department, just in the same hospital stay. Graft-Versus-Host Disease (GVHD). Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: GVHD grading using the Glucksberg grade scale. Oral mucositis. Timepoint: Before Stem Cell Transplantation and every 4 weeks for the first 3 months after transplantation. Method of measurement: WHO Oral Mucositis Grading Scale. The rate of re-admission related to stem cell transplantation. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: the number of days that patient admit in the post-transplant stem cell care unit. Signs and symptoms of infection. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Clinical examination and symptom registration. Anxiety. Timepoint: Before Stem Cell Transplantation and every 4 weeks for the first 3 months after transplantation. Method of measurement: The State-Trait Anxiety Inventory and VAS Tool. The main reason for re-admission. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Readmission Questionnaire. Days of readmission. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Readmission Questionnaire. Types of treatments performed on re-admission. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Readmission Questionnaire. Skin graft-versus-host disease. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: GVHD grading using the Glucksberg grade scale. Gastrointestinal graft-versus-host disease. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: GVHD grading using the Glucksberg grade scale. Hepatic graft-versus-host disease. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: GVHD grading using the Glucksberg grade scale. Fever. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Clinical examination and symptom registration. Shivering. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Clinical examination and symptom registration. Dysuria. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Clinical examination and symptom registration. Airway secretions. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Clinical examination and symptom registration. The cytomegalovirus (CMV) status. Timepoint: Every 4 weeks for the first 3 months after transplantation. Method of measurement: Using real time PCR (copies/mL). Vice chancellor for research of Tehran University of Medical Sciences Approved 2017-02-07 Ethics Committee of the Faculty of Nursing and Midwifery and Rehabilitation, Tehran University of M Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran Tehran Tehran Iran (Islamic Republic of)