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IRCT20240205060913N1 IRCT 2024-07-06 Shahid Beheshti University of Medical Sciences The effect of training based on the seven-step learning cycle on stroke patients and their caregivers The Effect of Training Based on The Seven-Step (7E) Learning Cycle on The Quality of Life of Stroke Patients and The Care Burden of Their Caregivers 2024-07-21 anticipated 120 Complete https://irct.ir/trial/75426 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization in this research will be done by block randomization method with a volume of four. The sequence of random allocation and the list of blocks will be obtained by the statistical consultant and with the help of R software. In this method, blocks are formed based on the variables in question. Block randomization is performed by randomizing participants into blocks, so that equal numbers are assigned to each group (intervention and control). Equal numbers of participants enter the groups in consecutive but equal time intervals. After each patient and family enters the ward, according to the prepared block of four (15 blocks of four) based on the sample size, in the first stage, each patient will be randomly placed in the A test group or the B control group. For example, after randomly selecting a block such as the ABAB block, patients are randomly placed in the test, control, test and control groups. After generating the random sequence, sampling is done by hiding the generated sequence. So that before assigning the individual, the assigned group is not known for the samples. This is done by putting a random sequence inside the envelope and choosing a non-transparent envelope. First, a random sequence is created, then based on the size of the research sample, a number of envelopes are prepared and each of the created random sequences is recorded on a card, and the cards are placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the envelopes is glued and placed in a box in order. At the time of starting the registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes is opened in order and the assigned group of that company The doer is revealed. Each patient's code will be assigned to his family member. People are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks, Blinding description: Data were collected by research assistants who were blinded to treatment allocation. N/A Stroke. Intervention 1: Intervention group: First of all, the demographic information questionnaire of the patient, caregivers and the quality of life questionnaire of stroke patients are completed by the patient and the CBI care burden questionnaire is completed by the caregiver. Then, based on the randomized blocks of four and the prepared envelopes, each patient and caregiver will be randomly assigned a code based on the order of entry into the study, and the patients will be placed in two test and control groups based on the random codes. . In the continuation of the beginner's training program based on the 7-step learning model in the test group, in 3 sessions of 30-40 minutes of face-to-face training (one individual session and two group sessions including groups of 4-6 people) and two virtual training sessions after discharge individually, about Definition of stroke disease, types of stroke (ischemic/hemorrhagic/transient ischemic), the importance of continuing treatment, the degree of compliance with the drug compliance program and the importance of drugs, the problems of stroke patients (special food program for patients with swallowing disorders, movement and speech rehabilitation program treatment), the principles of prevention of re-infection and team structure for treatment (the importance of the presence of the family with the patient and interaction in the educational program, the importance of playing the role of the patient and the family in various meetings and the treatment and care plan of the patient) and daily care of stroke patients and Prevention of reoccurrence includes teaching recommendations to prevent reoccurrence of stroke (control of anger, control of stressful stimuli, proper nutrition, adherence to medication and care) and education of the reasons for reoccurrence (non-compliance with medication and care plan, lack of family cooperation) In the treatment and care process of the patient, the patient's non-cooperation with the treatment staff and non-compliance with treatment and medication plans (to stroke based on the 7E learning cycle model) (inferring, involving, exploring, explaining, expanding, evaluating and expand) will be present. The first training session will be held individually for the patient and caregiver in the hospital. The second and third session will be conducted as a group training (including patient and caregiver) and after the clearance of other training content, it will be provided through virtual training at intervals of one session every week, and questionnaires will be completed again two weeks after the completion of the intervention. At the end of the study, in order to comply with ethical principles, educational content will be prepared from what was explained in the meetings and will be provided to all participants (control group). Then the data will be analyzed. Intervention 2: Control group: The control group will receive common training and routine care of the neurology department. In order to comply with ethical principles, educational content will be prepared from what was explained in the meetings and will be provided to all participants (control group). 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 Neda Sanaie
Valiasr St., Niayesh Intersection, Nursing and Midwifery Faculty
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 nedasanaie@ymail.com Shahid Beheshti University of Medical Sciences scientific Neda Sanaie
Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 nedasanaie@ymail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The age range of people is between 18 and 70 years. Willingness to participate in research Refer to the stroke clinic The patient has not received thrombolytic medicine and is hospitalized due to problems caused by stroke. Admitted to the neurology department of the hospitals covered by Shahid Beheshti University of Medical Sciences The patient is alert and aware of the time, place and person, and can be trained 18 years 70 years Both Suffering from known physical and mental diseases that affect the quality of life (according to the patient's self-report). People who do not attend two (or more) sessions out of the total number of follow-up sessions. People who have participated in another educational program during the research. People who have hearing, visual and touch disorders or who are not able to speak Persian language. People who have hearing, visual and touch disorders or who are not able to speak Persian language I67.82 Cerebral ischemia N/A N/A Intervention group: First of all, the demographic information questionnaire of the patient, caregivers and the quality of life questionnaire of stroke patients are completed by the patient and the CBI care burden questionnaire is completed by the caregiver. Then, based on the randomized blocks of four and the prepared envelopes, each patient and caregiver will be randomly assigned a code based on the order of entry into the study, and the patients will be placed in two test and control groups based on the random codes. . In the continuation of the beginner's training program based on the 7-step learning model in the test group, in 3 sessions of 30-40 minutes of face-to-face training (one individual session and two group sessions including groups of 4-6 people) and two virtual training sessions after discharge individually, about Definition of stroke disease, types of stroke (ischemic/hemorrhagic/transient ischemic), the importance of continuing treatment, the degree of compliance with the drug compliance program and the importance of drugs, the problems of stroke patients (special food program for patients with swallowing disorders, movement and speech rehabilitation program treatment), the principles of prevention of re-infection and team structure for treatment (the importance of the presence of the family with the patient and interaction in the educational program, the importance of playing the role of the patient and the family in various meetings and the treatment and care plan of the patient) and daily care of stroke patients and Prevention of reoccurrence includes teaching recommendations to prevent reoccurrence of stroke (control of anger, control of stressful stimuli, proper nutrition, adherence to medication and care) and education of the reasons for reoccurrence (non-compliance with medication and care plan, lack of family cooperation) In the treatment and care process of the patient, the patient's non-cooperation with the treatment staff and non-compliance with treatment and medication plans (to stroke based on the 7E learning cycle model) (inferring, involving, exploring, explaining, expanding, evaluating and expand) will be present. The first training session will be held individually for the patient and caregiver in the hospital. The second and third session will be conducted as a group training (including patient and caregiver) and after the clearance of other training content, it will be provided through virtual training at intervals of one session every week, and questionnaires will be completed again two weeks after the completion of the intervention. At the end of the study, in order to comply with ethical principles, educational content will be prepared from what was explained in the meetings and will be provided to all participants (control group). Then the data will be analyzed. Control group: The control group will receive common training and routine care of the neurology department. In order to comply with ethical principles, educational content will be prepared from what was explained in the meetings and will be provided to all participants (control group). "Quality of life" of stroke patients. Timepoint: Before the intervention and two months later. Method of measurement: Specific Quality of Life Questionnaire for Stroke Patients (SS-QOL). Family care burden. Timepoint: Before the intervention and two months later. Method of measurement: The family care burden questionnaire includes 24 items on a 5-point Likert scale. Shahid Beheshti University of Medical Sciences Approved 2024-01-21 Faculties of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of Medical Sciences Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital Tehran Tehran Iran (Islamic Republic of)