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IRCT20180113038347N2 IRCT 2022-01-11 Iran University of Medical Sciences The effect of the transitional care program from hospital to own home using the digital messaging application on self-efficacy, quality of life, cardiac symptoms, and medication adherence among patients undergoing coronary artery bypass graft surgery and caregiving burden in their family caregivers The effect of the transitional care program from hospital to own home using the digital messaging application on self-efficacy, quality of life, cardiac symptoms, and medication adherence among patients undergoing coronary artery bypass graft surgery and caregiving burden in their family caregivers 2022-02-04 anticipated 70 Complete https://irct.ir/trial/61178 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A quadruple random block design will be used to assign samples to two groups of control and intervention randomly. Code A (for the intervention group) and Code B (for the control group) will be considered. Then the required random blocks and their sequence will be determined using the website: https://www. sealedenvelope.com. Furthermore, sealed envelopes will be used for concealment. Thus, based on the sequence of randomly selected blocks, cards with the letters A (for the intervention group) or B (for the control group) indicating the assignment sequence will be placed inside the envelope. An envelope will then be opened for each participant in the study, respectively, and will be assigned to the control or intervention group based on the card inside the envelope. N/A Coronary artery bypass graft surgery. Intervention 1: Intervention group: Patients in the intervention group will receive an intervention designed according to a person-centered care approach based on evidence-based practice and clinical knowledge. This program will include the following: (1) The researcher (nurse) will interview the patient and his / her family caregiver after the patient's hospitalization and will receive information about the patient's daily life before surgery, symptoms, impact of symptoms on daily life, assessment of social status, need for post-discharge support, daily life activities, and motivation/goals. Then, a post-discharge care plan for the patient based on the needs extracted in the previous stage will be developed with the cooperation of the patient himself, his / her family caregiver, and the researcher based on the literature. The designed program will also be approved by the patient's physician in the hospital. This program, by default, covers self-care activities, how to take medication, management of cardiac symptoms, diet, sexual and social activity, physical activity, control of risk factors, and time to see a doctor. It should be noted that this program is person-centered and will be based on the needs of patients and their family caregivers. In addition, before discharge, if needed, patients and their family caregivers are taught how to use WhatsApp and the functions associated with this application. General educational content will be created by the research team based on a review of the literature and includes additional training on heart disease, regular monitoring of blood pressure and heart rate, nutrition (general recommendations), and wound care; (2) Then, in the intervention group, the educational content related to the designed care program will be sent by the researcher in the form of text messages, video messages, and video and voice calls using the WhatsApp program to the patients and their family caregivers twice a week in the first 4 weeks of the intervention and then once a week in the second 4 weeks of the intervention (based on agreement with them). In addition, additional training on heart disease, regular control of blood pressure and heart rate, nutrition (general recommendations), wound care (number of participants in each WhatsApp group for effective management by the researcher 5-8 people Will be) will be provided in a WhatsApp group. Moreover, twice a week patients will be asked about the presence of cardiac symptoms (angina, shortness of breath, fatigue, depression, sleep problems and pain at surgery, swelling of the legs, increased heart rate, anxiety, and anorexia) and If there are any symptoms, the necessary training will be provided in the form of a message according to the needs of patients and their family caregivers and the researcher will adjust the care program according to the needs of the patient at this stage. Furthermore, patients and their family caregivers will be free to share their concerns and questions with the researcher 24 hours a day, 7 days a week. At this stage, patients will be regularly encouraged to follow the care plan. Intervention 2: Control group: Patients and their family caregivers in the control group will receive routine care during discharge, including advice on cardiac symptom management, physical activity, medication, diet, and time to see a doctor based on face-to-face instruction and pamphlets by the ward nurse. 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 The data file will be provided to interested authors upon reasonable request after the publication of related articles.
public Abbas Mardani
VVali Asr St., above Vanak Square, Rashid Yasemi St
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 abbasmardani30@gmail.com Iran University of Medical Sciences scientific Abbas Mardani
VVali Asr St., above Vanak Square, Rashid Yasemi St
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 abbasmardani30@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria for patients: Age over 18 years Performing coronary artery bypass graft (CABG) surgery for the first time in patients No concomitant surgery during CABG surgery Absence of respiratory diseases Absence of drug and alcohol addiction No history of seizures or mental health problems No disturbance of consciousness or cognitive problems Living with a family caregiver (spouse or children) Have adequate health literacy Having a smartphone Ability to use WhatsApp Conscious consent to participate in the study Inclusion criteria for family caregivers: Age over 18 years A close family member of the patient Lack of a history of any mental health problems Living with the patient Have adequate health literacy Having a smartphone Ability to use WhatsApp Ability to communicate effectively The first experience of caring for a patient undergoing CABG surgery Conscious consent to participate in the study 18 years no limit Both Exclusion criteria for patients: Patient dissatisfaction to continue working with the researcher Re-hospitalization of the patient during the research Patient death during the intervention Exclusion criteria for family caregivers: Dissatisfaction to continue working with the researcher Patient death during the intervention I25.7 Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris Rehabilitation Rehabilitation Intervention group: Patients in the intervention group will receive an intervention designed according to a person-centered care approach based on evidence-based practice and clinical knowledge. This program will include the following: (1) The researcher (nurse) will interview the patient and his / her family caregiver after the patient's hospitalization and will receive information about the patient's daily life before surgery, symptoms, impact of symptoms on daily life, assessment of social status, need for post-discharge support, daily life activities, and motivation/goals. Then, a post-discharge care plan for the patient based on the needs extracted in the previous stage will be developed with the cooperation of the patient himself, his / her family caregiver, and the researcher based on the literature. The designed program will also be approved by the patient's physician in the hospital. This program, by default, covers self-care activities, how to take medication, management of cardiac symptoms, diet, sexual and social activity, physical activity, control of risk factors, and time to see a doctor. It should be noted that this program is person-centered and will be based on the needs of patients and their family caregivers. In addition, before discharge, if needed, patients and their family caregivers are taught how to use WhatsApp and the functions associated with this application. General educational content will be created by the research team based on a review of the literature and includes additional training on heart disease, regular monitoring of blood pressure and heart rate, nutrition (general recommendations), and wound care; (2) Then, in the intervention group, the educational content related to the designed care program will be sent by the researcher in the form of text messages, video messages, and video and voice calls using the WhatsApp program to the patients and their family caregivers twice a week in the first 4 weeks of the intervention and then once a week in the second 4 weeks of the intervention (based on agreement with them). In addition, additional training on heart disease, regular control of blood pressure and heart rate, nutrition (general recommendations), wound care (number of participants in each WhatsApp group for effective management by the researcher 5-8 people Will be) will be provided in a WhatsApp group. Moreover, twice a week patients will be asked about the presence of cardiac symptoms (angina, shortness of breath, fatigue, depression, sleep problems and pain at surgery, swelling of the legs, increased heart rate, anxiety, and anorexia) and If there are any symptoms, the necessary training will be provided in the form of a message according to the needs of patients and their family caregivers and the researcher will adjust the care program according to the needs of the patient at this stage. Furthermore, patients and their family caregivers will be free to share their concerns and questions with the researcher 24 hours a day, 7 days a week. At this stage, patients will be regularly encouraged to follow the care plan. Control group: Patients and their family caregivers in the control group will receive routine care during discharge, including advice on cardiac symptom management, physical activity, medication, diet, and time to see a doctor based on face-to-face instruction and pamphlets by the ward nurse. Self- efficacy. Timepoint: Before the intervention, at the end of the intervention and two months after the intervention. Method of measurement: Cardiac Self-Efficacy Scale. Quality of life. Timepoint: Before the intervention, at the end of the intervention and two months after the intervention. Method of measurement: MacNew Heart Disease HRQL questionnaire. Cardiac symptoms. Timepoint: Before the intervention, at the end of the intervention and two months after the intervention. Method of measurement: Cardiac Symptom Scale. Medication adherance. Timepoint: Before the intervention, at the end of the intervention and two months after the intervention. Method of measurement: Morisky Medication Adherence Scale. Caregiving burden. Timepoint: Before the intervention, at the end of the intervention and two months after the intervention. Method of measurement: Caregiver Burden Scale. Iran University of Medical Sciences Approved 2022-01-02 Ethics committee of Iran University of Medical Sciences Tehran, Hemmat Highway next to Milad Tower, Iran University of Tehran Tehran Iran (Islamic Republic of)