]>
IRCT20230115057132N1 IRCT 2023-02-21 Jahrom University of Medical Sciences effect of implementing continuous care model on self-care behaviors of thalassemia major patients Evaluation of the effect of implementing continuous care model on self-care behaviors of thalassemia major patients 2023-02-25 anticipated 56 Complete https://irct.ir/trial/68673 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, in order to make the research conditions uniform for both groups, random allocation method will be used. If the patient is placed in the intervention group, the follow-up care model will be implemented, but no intervention will be done for the control group, Randomization description: Sampling will be done first by census and then the patients who meet the inclusion criteria will be randomly selected in accordance with the required sample size of 56 people and randomly assigned to two control groups (code 1) and random allocation software. The intervention group (code 2) will be divided. N/A The effect of follow-up care on self-care behaviors of thalassemia major patients. Intervention 1: Intervention group: The intervention for patients in the intervention group will be carried out for 3 months as follows: 1- The first stage of the continuous care model, i.e. the familiarization stage by the student researcher who conducts the study daily during the first 2 weeks of the research, will be carried out in the surroundings of Motahari Hospital in Jahrom, during which the patients will get to know the researcher better. Clarifying the expectations from each other, explaining the steps of the model, determining the agreement for face-to-face and telephone meetings will be implemented, and the contact number of the researcher will be provided to the patients of the intervention group for further follow-up.Community Verified icon 2- The second stage of follow-up care is the sensitization stage in order to involve the patient regarding the implementation of a continuous approach in the follow-up care model and its purpose is to introduce the nature of thalassemia disease to patients, thalassemia complications and thalassemia disease treatments, the role of exercise and nutrition in disease management. Psychosocial issues and sensitizing the patient to self-care behaviors in the disease will be in coordination with the patients and the head of the Colitis Department in the educational hall of Motahari Hospital, four sessions of one and a half hours in a month based on the chapter of educational content extracted from scientific texts and articles and reviews The educational needs expressed by the participants will be through the needs assessment forms that will be provided to them And after the approval of the educational content by the supervisor and the consultant, a master's degree student who is a member of the research team will give lectures and show educational videos and conduct questions and answers with the training participants as a group in the conference hall of Motahari Hospital to the patients of the intervention group. became. The sequence of sessions of the sensitization phase is as follows: the subject of the training in the first session, which will be implemented during the first week, is the nature of thalassemia major and blood transfusion and treatment and its side effects. The relationship between exercise and smoking for thalassemia patients and in the fourth session, education will be related to nutrition in thalassemia In coordination with the patients, after the sensitization phase of the second phase test, which will be 6 weeks after the start of the intervention, during the seventh week, with the aim of measuring self-care behaviors in both the intervention and control groups individually, using the questionnaire of self-care behaviors of early-onset thalassemia patients. It will be done in person at the Motahari hospital. At this stage, if it is not possible to attend the hospital for some patients in two groups due to reasons such as the distance of the route, etc., the patients will be asked to fill out the questionnaire of self-care behaviors individually. Read the questionnaire that is sent to their mobile phone by the researcher virtually through the website and complete it with an emphasis on the confidentiality of the information and send it to the researcher with one of the Iranian messengers, or if this is not possible for the patients, the researcher will contact the patients and complete the questionnaire of self-care behaviors by calling and asking the questions for them. 3- In the third stage of follow-up care, which is the control stage, and the goal is to institutionalize and continue health behaviors in order to improve health, in which the researcher conducting the study will contact the patients of the intervention group twice a week on Saturdays and Tuesdays for 6 weeks. On Saturday, he will make a phone call and use the phone call to remind the patients of the training that was given to the patients in the previous face-to-face classes with emphasis on self-care behaviors, and their questions will be answered And the patients of the intervention group are reminded that again, if they have any questions or problems related to the training given, they can call the researcher to receive the necessary guidance over the phone again. Although in the continuous care model, evaluation as The final stage of the model has been proposed, but due to the nature of the follow-up care model, process evaluation will be considered and current in all stages of the model implementation, and the outcome or final evaluation, such as the evaluation of the seventh week, which was the second time Again, using the questionnaire of self-care behaviors of patients with thalassemia major for the third time, thirteen weeks after the start of the study, in the fourteenth week in both the intervention and control groups, in person and individually at Motahari Hospital, and if the patient was not present at the hospital that week It will be measured virtually or by making a phone call. Intervention 2: Control group: Control group: In Opteda, the questionnaire of self-care behaviors of patients with thalassemia major will be provided to them, and after completing the questionnaire, no intervention other than the treatment measures that are usually performed for these patients will be carried out, after six months have passed. One week and after the end of the intervention, after completing the questionnaire that was presented to the patients in the first session, the questionnaire will be given to the control group two more times, so that the self-care behaviors of the patients will be measured again. It will be available to patients to use its content. 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 We will make a decision in this regard after conducting the study
public Rasool Eslami Akbar
Motahari Street, Jahrom University of Medical Sciences
Jahrom Iran (Islamic Republic of) 7414846199 +98 71 5434 0409 m.mohit@jums.ac.ir Jahrom University of Medical Sciences scientific Rasool Eslami akbar
Motahari Street, Jahrom University of Medical Sciences
Jahrom Iran (Islamic Republic of) 7414846199 +98 71 5434 0409 m.mohit@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Thalassemia major patients who are over 18 years old Be literate Willingness and consent of the patient to participate in the study 18 years no limit Both Age less than 18 years Lack of literacy The patient's unwillingness to cooperate The occurrence of severe physical complications caused by the disease D56.1 Beta thalassemia Rehabilitation Rehabilitation Intervention group: The intervention for patients in the intervention group will be carried out for 3 months as follows: 1- The first stage of the continuous care model, i.e. the familiarization stage by the student researcher who conducts the study daily during the first 2 weeks of the research, will be carried out in the surroundings of Motahari Hospital in Jahrom, during which the patients will get to know the researcher better. Clarifying the expectations from each other, explaining the steps of the model, determining the agreement for face-to-face and telephone meetings will be implemented, and the contact number of the researcher will be provided to the patients of the intervention group for further follow-up.Community Verified icon 2- The second stage of follow-up care is the sensitization stage in order to involve the patient regarding the implementation of a continuous approach in the follow-up care model and its purpose is to introduce the nature of thalassemia disease to patients, thalassemia complications and thalassemia disease treatments, the role of exercise and nutrition in disease management. Psychosocial issues and sensitizing the patient to self-care behaviors in the disease will be in coordination with the patients and the head of the Colitis Department in the educational hall of Motahari Hospital, four sessions of one and a half hours in a month based on the chapter of educational content extracted from scientific texts and articles and reviews The educational needs expressed by the participants will be through the needs assessment forms that will be provided to them And after the approval of the educational content by the supervisor and the consultant, a master's degree student who is a member of the research team will give lectures and show educational videos and conduct questions and answers with the training participants as a group in the conference hall of Motahari Hospital to the patients of the intervention group. became. The sequence of sessions of the sensitization phase is as follows: the subject of the training in the first session, which will be implemented during the first week, is the nature of thalassemia major and blood transfusion and treatment and its side effects. The relationship between exercise and smoking for thalassemia patients and in the fourth session, education will be related to nutrition in thalassemia In coordination with the patients, after the sensitization phase of the second phase test, which will be 6 weeks after the start of the intervention, during the seventh week, with the aim of measuring self-care behaviors in both the intervention and control groups individually, using the questionnaire of self-care behaviors of early-onset thalassemia patients. It will be done in person at the Motahari hospital. At this stage, if it is not possible to attend the hospital for some patients in two groups due to reasons such as the distance of the route, etc., the patients will be asked to fill out the questionnaire of self-care behaviors individually. Read the questionnaire that is sent to their mobile phone by the researcher virtually through the website and complete it with an emphasis on the confidentiality of the information and send it to the researcher with one of the Iranian messengers, or if this is not possible for the patients, the researcher will contact the patients and complete the questionnaire of self-care behaviors by calling and asking the questions for them. 3- In the third stage of follow-up care, which is the control stage, and the goal is to institutionalize and continue health behaviors in order to improve health, in which the researcher conducting the study will contact the patients of the intervention group twice a week on Saturdays and Tuesdays for 6 weeks. On Saturday, he will make a phone call and use the phone call to remind the patients of the training that was given to the patients in the previous face-to-face classes with emphasis on self-care behaviors, and their questions will be answered And the patients of the intervention group are reminded that again, if they have any questions or problems related to the training given, they can call the researcher to receive the necessary guidance over the phone again. Although in the continuous care model, evaluation as The final stage of the model has been proposed, but due to the nature of the follow-up care model, process evaluation will be considered and current in all stages of the model implementation, and the outcome or final evaluation, such as the evaluation of the seventh week, which was the second time Again, using the questionnaire of self-care behaviors of patients with thalassemia major for the third time, thirteen weeks after the start of the study, in the fourteenth week in both the intervention and control groups, in person and individually at Motahari Hospital, and if the patient was not present at the hospital that week It will be measured virtually or by making a phone call. Control group: Control group: In Opteda, the questionnaire of self-care behaviors of patients with thalassemia major will be provided to them, and after completing the questionnaire, no intervention other than the treatment measures that are usually performed for these patients will be carried out, after six months have passed. One week and after the end of the intervention, after completing the questionnaire that was presented to the patients in the first session, the questionnaire will be given to the control group two more times, so that the self-care behaviors of the patients will be measured again. It will be available to patients to use its content. The total score of the self-care behaviors of the patients, which is measured by the initial self-care behaviors questionnaire, which scores the self-care behaviors of thalassemia major patients with a 5-part scale, is given a score of 4 for always, 3 for most of the time, 2 for sometimes, 1 for rarely, and 0 for never. The total score of the questionnaire is in the range of 0 to 84. Timepoint: before the start of the intervention and six weeks and twelve weeks after the end of the study. Method of measurement: The initial self-care behavior questionnaire, which scores the self-care behaviors of thalassemia major patients with a 5-part scale, is measured in such a way that 4 points are always given, most of the time 3 points, sometimes 2 points, rarely 1 point, and never 0 points. The total score of the questionnaire ranges from 0 to 84. Jahrom University of Medical Sciences Approved 2023-02-19 Ethics Committee of Jahrom University of Medical Sciences Jahrom University of Medical Sciences Jahrom Fars Iran (Islamic Republic of)