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IRCT20221031056352N1 IRCT 2023-02-16 Tabriz University of Medical Sciences The Influence of Individualized Education on Hemodialysis Patients The Influence of Individualized Education on Learning Needs, Uncertainty in Illness, and Patient Activation among Hemodialysis Patients: A Randomized Controlled Clinical Trial 2023-11-22 anticipated 106 Complete https://irct.ir/trial/66633 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The selection of participants will be based on simple random block design with blocks of 4 and 6 and with the ratio of allocation one to one (1:1) for intervention (individualized education) and control groups (educational brochures). In order to the allocation concealment, the method of Using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) will be used. In this way, after creating a random sequence, based on the sample size, a number of opaque letter envelopes will be placed inside the letter envelopes in order to avoid the clarity of the contents of the envelopes. The numbering will be done in the same order. Finally, the lid of the envelopes will be glued and they will be placed in a box in order. At the time of the participation of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes The letter will be opened in order and the assigned group of that participant will be revealed. Blocking and preparation of letter envelopes will be done by someone other than the research team, Blinding description: In order to prevent the Hawthorne effect, the educator will be careful that the participants not aware of their allocation in the intervention or control group. Data collection and pre-test and post-test will be done by the trained researchers and they will not be aware of the division of participants into intervention and control groups. N/A Hemodialysis Care. Intervention 1: The patients will be asked to determine their goals on diet, physical activity and proper weight gain, taking medications and managing complications related to the disease. In order to set goals, participants will be motivated and will be supported in setting goals for their disease management. In order to motivation, examples of patients who play an active role in managing their disease and experience fewer hemodialysis complications will be mentioned. The first session will last about up to 60 minutes. In the next sessions, according to the information obtained in the first session and based on the needs, conditions, education level, age and cognitive status of each patient, individualized education will be provided. In order to prevent distraction and disruption in the education session, the education will be provided mainly at the beginning of the hemodialysis sessions and after connecting to the hemodialysis machine. The education will be provided at the bedside of each patient by a master of science Medical- Surgical nursing student, who has a certificate of hemodialysis nursing skill course. The duration of the sessions will be individualized and will vary from 10 to 45 minutes & it will continue until the patient does not feel tired, cooperates and does not have complications such as hypotension. In addition, the education will be in the favorite language of each patient (Persian or Turkish). In addition, in the presentation of educational materials, simple and understandable sentences will be used for each patient, and the use of specialized and incomprehensible terms for the patient will be avoided. The educational content will be prepared based on the latest version of the authoritative guidelines of dialysis (Kidney Disease Outcomes Quality Initiative (KDOQI)) (5-8). Also, the content validity of the individualized education program will be evaluated by a specialized group that includes a nephrology subspecialist, nursing teachers, a hemodialysis supervisor, and an experienced hemodialysis nurse. The educational content will be presented in 4 steps: In the first step, about the nature of the disease, symptoms, complications, warning signs, follow-up (time to see a doctor), prognosis and other alternative treatments, individualized education will be presented. In the second step, individualized education will be provided about proper diet, water, salt, protein, vitamins, physical activity, and proper weight. In the third step, about the medications that each patient takes (application, possible side effects, warning signs, prohibitions on the use of medicines) will be discussed. In the fourth step, the management of complications related to the disease in each patient (skin care and Access, skin edema and itching, constipation, anemia, etc.) will be discussed. The educational content will be presented orally and face-to-face based on the patient's condition. At the end of each session, the patient will be encouraged to ask his questions. If specialized questions are raised, the patient's nephrologist will be consulted and the appropriate answer will be provided to the patient. If the patient's problems are outside the expertise of the research team (for example, having problems and questions about orthopedics, infectious diseases, etc.), they will be referred to the relevant specialist doctor and the follow-up will be done for the patient's referral. Also, in order to ensure the patient's understanding of the educational materials presented, feedback will be obtained from each patient at the end of each educational session. Also, at the beginning of each session, the materials presented in the previous sessions will be reviewed and some questions will be asked. If the patient cannot remember the material presented in the previous sessions, that material will be repeated. Also, the patient will be asked about the application of the provided educational materials. If the participant is successful in achieving the goals, strategies such as positive support, effective feedback, and encouragement will be implemented in order to maintain successful behavior. If the participant is not successful in using the educational materials, the obstacles will be checked and the appropriate solution will be provided in partnership with each patient. The educational sessions will continue until the patient is able to express the content correctly and answer the researcher's questions correctly. Individualized education sessions will vary from 3 to 6 sessions. In order to maintain continuity in education and prevent forgetting educational materials, at least one educational session will be held for each participant every week. Also, patients can ask their questions by phone or by sending SMS and receive answers to their questions in this way. Intervention 2: Control group: The participants of the control group will only receive the educational brochures which are routinely provided by the hemodialysis department of the hospital. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mansoor Ghafourifard
Nursing and midwifery faculty, Shariati Jonoubi, Tabriz
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3479 6770 ghafourifardm@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mansoor Ghafourifard
Nursing and midwifery faculty, Shariati Jonoubi, Tabriz
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3479 6770 ghafourifardm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with a definitive diagnosis of end-stage kidney disease based on medical records Age over 18 years Receiving hemodialysis at least 3 times a week 18 years no limit Both Patients who have been treated by hemodialysis for less than three months. Patients with mental disorder (severe depression and dementia) according to the report of the patient or family or based on the patient's records. Patients with cognitive disorders based on Mini-Mental State Examination (MMSE) Z49 Encounter for care involving renal dialysis Other Other The patients will be asked to determine their goals on diet, physical activity and proper weight gain, taking medications and managing complications related to the disease. In order to set goals, participants will be motivated and will be supported in setting goals for their disease management. In order to motivation, examples of patients who play an active role in managing their disease and experience fewer hemodialysis complications will be mentioned. The first session will last about up to 60 minutes. In the next sessions, according to the information obtained in the first session and based on the needs, conditions, education level, age and cognitive status of each patient, individualized education will be provided. In order to prevent distraction and disruption in the education session, the education will be provided mainly at the beginning of the hemodialysis sessions and after connecting to the hemodialysis machine. The education will be provided at the bedside of each patient by a master of science Medical- Surgical nursing student, who has a certificate of hemodialysis nursing skill course. The duration of the sessions will be individualized and will vary from 10 to 45 minutes & it will continue until the patient does not feel tired, cooperates and does not have complications such as hypotension. In addition, the education will be in the favorite language of each patient (Persian or Turkish). In addition, in the presentation of educational materials, simple and understandable sentences will be used for each patient, and the use of specialized and incomprehensible terms for the patient will be avoided. The educational content will be prepared based on the latest version of the authoritative guidelines of dialysis (Kidney Disease Outcomes Quality Initiative (KDOQI)) (5-8). Also, the content validity of the individualized education program will be evaluated by a specialized group that includes a nephrology subspecialist, nursing teachers, a hemodialysis supervisor, and an experienced hemodialysis nurse. The educational content will be presented in 4 steps: In the first step, about the nature of the disease, symptoms, complications, warning signs, follow-up (time to see a doctor), prognosis and other alternative treatments, individualized education will be presented. In the second step, individualized education will be provided about proper diet, water, salt, protein, vitamins, physical activity, and proper weight. In the third step, about the medications that each patient takes (application, possible side effects, warning signs, prohibitions on the use of medicines) will be discussed. In the fourth step, the management of complications related to the disease in each patient (skin care and Access, skin edema and itching, constipation, anemia, etc.) will be discussed. The educational content will be presented orally and face-to-face based on the patient's condition. At the end of each session, the patient will be encouraged to ask his questions. If specialized questions are raised, the patient's nephrologist will be consulted and the appropriate answer will be provided to the patient. If the patient's problems are outside the expertise of the research team (for example, having problems and questions about orthopedics, infectious diseases, etc.), they will be referred to the relevant specialist doctor and the follow-up will be done for the patient's referral. Also, in order to ensure the patient's understanding of the educational materials presented, feedback will be obtained from each patient at the end of each educational session. Also, at the beginning of each session, the materials presented in the previous sessions will be reviewed and some questions will be asked. If the patient cannot remember the material presented in the previous sessions, that material will be repeated. Also, the patient will be asked about the application of the provided educational materials. If the participant is successful in achieving the goals, strategies such as positive support, effective feedback, and encouragement will be implemented in order to maintain successful behavior. If the participant is not successful in using the educational materials, the obstacles will be checked and the appropriate solution will be provided in partnership with each patient. The educational sessions will continue until the patient is able to express the content correctly and answer the researcher's questions correctly. Individualized education sessions will vary from 3 to 6 sessions. In order to maintain continuity in education and prevent forgetting educational materials, at least one educational session will be held for each participant every week. Also, patients can ask their questions by phone or by sending SMS and receive answers to their questions in this way. Control group: The participants of the control group will only receive the educational brochures which are routinely provided by the hemodialysis department of the hospital. Patient Learning Needs. Timepoint: At the beginning of the study (before the intervention), after the end of the intervention and also 3 months after the last individualized education session. Method of measurement: Patient Learning Needs Scale (PLNS). Uncertainty in Illness. Timepoint: At the beginning of the study (before the intervention), after the end of the intervention and also 3 months after the last individualized education session. Method of measurement: Mishel Uncertainty in Illness Scale (MUIS). Patient Activation. Timepoint: At the beginning of the study (before the intervention), after the end of the intervention and also 3 months after the last individualized education session. Method of measurement: Patient Activation Measure (PAM). Intra Dialysis Weight Gain (IDWG). Timepoint: At the beginning of the study (before the intervention), after the end of the intervention and also 3 months after the last individualized education session. Method of measurement: Scale. Hemodialysis adequacy. Timepoint: At the beginning of the study (before the intervention), after the end of the intervention and also 3 months after the last individualized education session. Method of measurement: Blood Test. Urea & creatinine levels. Timepoint: At the beginning of the study (before the intervention), after the end of the intervention and also 3 months after the last individualized education session. Method of measurement: Blood Test. Tabriz University of Medical Sciences Approved 2023-01-23 Ethics committee of Tabriz University of Medical Sciences Golgasht, Tabriz University of Medical Science, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)