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IRCT20200810048354N1 IRCT 2020-09-12 Tehran University of Medical Sciences Effect of Continuous Care Model on Self-management in patients with systemic lupus erythematosus The Effect of Continuous Care Model on Self-Management In patients with Systemic Lupus Erythematosus 2019-10-23 anticipated 88 Complete https://irct.ir/trial/50228 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible samples enter the study by block sampling and then allocated in control and intervention groups. Letter A is for intervention Group and letter B is for control group. We consider all the possible permutation compounds of A and B which is consisted of six different compounds on six cards. 1. AABB 2. ABBA 3. ABAB 4. BAAB 5. BABA 6. BBAA Then we Choose a number between one to six by using the random numbers table. For example if the option two was chosen, it means the fist sample enters the intervention group and the next two samples place in control group and the fourth sample will be in intervention group. We Continue as so to complete the sample size. N/A Systemic Lupus Erythematosus. Intervention 1: Intervention group: Intervention group: before starting the research and intervention, Informed consent form would be completed by patients and they will be informed about research method. Research tools is a questionnaire which consists two sections. Section one is the demographic information questionnaire and section two is PIH (Partners in health) questionnaire which is completed by patients themselves. Samples of intervention group will be instructed based on the continuous care model. The first session of instruction that is the orientation stage of the model will be held through a lecture by researcher and answering the questions in about thirty to sixty minutes. Aims of this session is introducing patients and their family to researcher, talking about patient education methods, explaining the different steps of patient's education and explaining the mutual expectations between the patient and the nurse. In this stage both questionnaires will be completed. Second stage of the continuous care model which is sensitization, aimed to involve patient and family in continuous care and increasing the information and knowledge of patient and family to gain self management ability including: Disease related knowledge, pharmaceutical treatment and health conditions. Partnership in treatment including: Medical adherence, therapeutic decision makings and treatment follow ups. Recognition and management of symptoms including: Recognition warning signs and managing symptoms. And coping which is including: managing physical activities, managing mental and psychological conditions, managing the social life and life style. Educational sessions in this stage will be held through lectures and asking question by patients in three sessions a week for maximum of two hours. In the first session, researched explains about the chronic nature of lupus, Its definition, signs and symptoms, accurate recognition of health problems and boosters of disease, the importance and advantages of phone consultancy and changing life style and also answering the patient's questions with underlining the risk factors. In the second session main drugs of the disease, Side effects, the importance of medical and therapeutic adherence and different prescription methods of lupus drugs will be introduced and the third session will be about maintaining the proper regimen, the importance of physical activity, recommendations on skin care, increasing the coping level and introducing the non-medical ways of stress reduction. At the end of the third session, the educational booklet will be available to patients of intervention group. In the control stage and with a week interval with the last session, the researcher contact the samples for eight weeks to consult the patients in order to complete the face to face meetings. In these sessions, patient's questions will be answered and they will be guided in performing the instructions. The patients will be instructed to complete the questionnaire once a week and reporting the results to researcher. Finally after the end of telephone sessions, the process of patient's care and successions and failures will be evaluated and at the end of the eighth week the questionnaire will be completed for the last time. Intervention 2: Control group: before starting the research and intervention, Informed consent form would be completed by patients and they will be informed about research method. Research tools is a questionnaire which consists two sections. Section one is the demographic information questionnaire and section two is PIH (Partners in health) questionnaire which is completed by patients themselves. In the control group after introducing the patient and explaining the aim of research, the PIH questionnaire will be completed. To prevent contamination of samples, the educational booklet will be available for control group at the end of the study. We will have weekly phone call with the samples of control group too. There won't be any professional consultants in these calla and phone calls are just for reminding to complete the questionnaire. In this way samples will be prevented from falling. The PIH questionnaire will be completed same as intervention group. Yes - There is a plan to make this available What will be shared: Participants answers to Partners in health questionnaires can be shared. When: Results can be shared two month after printing the final study. To whom: Researchers in Academic and Scientific fields Conditions: Using datas and results of current study for future similar studies. Where to obtain: Contact the authors of the study via E mail. Contact Negin Hosseini Hamze via n-hosseinihamze@razi.tums.ac.ir Contact Dr. Shokhoh Varaei Via shvaraei@tums.ac.ir How to obtain: Applier will Send an E mail to authors. The request will be checked and after confirmation of applier's identity, requested documents will be sent to him/her. Comments:
public Negin Hosseini hamze
No. 13, Irandost St, abuzar Blvd, piroozi Ave, Tehran City
Tehran Iran (Islamic Republic of) 1767677973 +98 21 3306 6727 n-hosseinihamze@razi.tums.ac.ir Tehran University of Medical Sciences scientific Negin Hosseini hamze
No. 13, Irandost St, abuzar Blvd, piroozi Ave, Tehran City
Tehran Iran (Islamic Republic of) 1767677973 +98 21 3306 6727 n-hosseinihamze@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adults Over 20 years Old Their disease diagnosed less than a year Ability to Read and Write Willing to participate in the study Ability to comprehend Persian Be able to make contact for the follow-up stage of the study Lack of motion Defect 20 years no limit Both Reluctance to continue research Incidence of debilitating complication during research M32 Systemic lupus erythematosus (SLE) Behavior Behavior Intervention group: Intervention group: before starting the research and intervention, Informed consent form would be completed by patients and they will be informed about research method. Research tools is a questionnaire which consists two sections. Section one is the demographic information questionnaire and section two is PIH (Partners in health) questionnaire which is completed by patients themselves. Samples of intervention group will be instructed based on the continuous care model. The first session of instruction that is the orientation stage of the model will be held through a lecture by researcher and answering the questions in about thirty to sixty minutes. Aims of this session is introducing patients and their family to researcher, talking about patient education methods, explaining the different steps of patient's education and explaining the mutual expectations between the patient and the nurse. In this stage both questionnaires will be completed. Second stage of the continuous care model which is sensitization, aimed to involve patient and family in continuous care and increasing the information and knowledge of patient and family to gain self management ability including: Disease related knowledge, pharmaceutical treatment and health conditions. Partnership in treatment including: Medical adherence, therapeutic decision makings and treatment follow ups. Recognition and management of symptoms including: Recognition warning signs and managing symptoms. And coping which is including: managing physical activities, managing mental and psychological conditions, managing the social life and life style. Educational sessions in this stage will be held through lectures and asking question by patients in three sessions a week for maximum of two hours. In the first session, researched explains about the chronic nature of lupus, Its definition, signs and symptoms, accurate recognition of health problems and boosters of disease, the importance and advantages of phone consultancy and changing life style and also answering the patient's questions with underlining the risk factors. In the second session main drugs of the disease, Side effects, the importance of medical and therapeutic adherence and different prescription methods of lupus drugs will be introduced and the third session will be about maintaining the proper regimen, the importance of physical activity, recommendations on skin care, increasing the coping level and introducing the non-medical ways of stress reduction. At the end of the third session, the educational booklet will be available to patients of intervention group. In the control stage and with a week interval with the last session, the researcher contact the samples for eight weeks to consult the patients in order to complete the face to face meetings. In these sessions, patient's questions will be answered and they will be guided in performing the instructions. The patients will be instructed to complete the questionnaire once a week and reporting the results to researcher. Finally after the end of telephone sessions, the process of patient's care and successions and failures will be evaluated and at the end of the eighth week the questionnaire will be completed for the last time. Control group: before starting the research and intervention, Informed consent form would be completed by patients and they will be informed about research method. Research tools is a questionnaire which consists two sections. Section one is the demographic information questionnaire and section two is PIH (Partners in health) questionnaire which is completed by patients themselves. In the control group after introducing the patient and explaining the aim of research, the PIH questionnaire will be completed. To prevent contamination of samples, the educational booklet will be available for control group at the end of the study. We will have weekly phone call with the samples of control group too. There won't be any professional consultants in these calla and phone calls are just for reminding to complete the questionnaire. In this way samples will be prevented from falling. The PIH questionnaire will be completed same as intervention group. Self management score based on PIH questionnaire. Timepoint: Evaluating self management score before the intervention and during eight weeks of intervention. Method of measurement: Partners in Health questionnaire. Knowledge score. Timepoint: Evaluating knowledge score before the intervention and during eight weeks of intervention. Method of measurement: Partners in Health questionnaire. Recognition and management of symptoms score. Timepoint: Evaluating recognition and management of symptoms score before the intervention and during eight weeks of intervention. Method of measurement: Partners in Health questionnaire. Coping score. Timepoint: Evaluating coping score before the intervention and during eight weeks of intervention. Method of measurement: Partners in Health questionnaire. Partnership in treatment. Timepoint: Evaluating Partnership in treatment score before the intervention and during eight weeks of intervention. Method of measurement: Partners in Health questionnaire. Tehran University of Medical Sciences Approved 2019-10-13 National Research Ethics Committee No.13, Irandost St, Abuzar Blvd, Piroozi Ave Tehran Tehran Iran (Islamic Republic of)