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IRCT20250908067182N1 IRCT 2025-09-25 Tehran University of Medical Sciences Comparing the Effectiveness of Interactive Intelligent Chat bots and Virtual Education in Early Palliative Care for Heart Failure Patients Comparing the Effectiveness of Interactive Intelligent Chatbots and Virtual Education in Early Palliative Care for Heart Failure Patients on Expected Outcomes 2025-11-01 anticipated 90 Recruiting https://irct.ir/trial/86071 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: This randomize clinical trial will be divided into three groups (two intervention groups and one control group) using randomized block allocation with replacement. To this end, blocks of six are selected. The first intervention group is designated with the letter A, the second intervention group with the letter B, and the control group with the letter C. All possible combinations are written on separate cards, and each card is assigned a number. These numbers are then written on paper and randomly drawn until the required sample size is achieved. Allocation concealment will be performed using sealed envelopes. Specifically, one of the letters (A, B, or C) is placed inside each envelope according to the predetermined sequence, and then the envelope is sealed by a research collaborator and provided to the investigator. N/A heart failure. Intervention 1: Intervention group: The participants will receive online education, and the intervention will be implemented based on the ENABLE model in an online format. Initially, an in-person session will be held with patients and their family caregivers, during which necessary information will be provided regarding their disease, palliative care, and the structure of the intervention program. Afterwards, a six-week early palliative care program will be delivered through weekly webinars via Google Meet or Skyroom. Each session will last between 45 minutes and one hour. Intervention 2: Intervention group: Participants will receive the educational content via a chatbot. The intervention, based on the ENABLE model, will be delivered through an intelligent interactive chatbot. First, an in-person training session will be held for the patient and their family caregiver on how to use the chatbot (installation, login, and interaction). In addition, initial training will be provided on how to use the system, how to ask questions, how to recognize emergency conditions, and an introduction to the applications of the chatbot. A written user guide will also be accessible within the system. The educational content, developed according to the ENABLE model, will be prepared in the form of short text files, simple audio files, infographics, and short videos, and then uploaded to the chatbot’s internal platform. The duration of the intervention will be six weeks, similar to the first group. To assess adherence to chatbot use, engaging with the chatbot less than twice per week for two consecutive weeks will be considered a significant reduction in adherence. In such cases, in addition to reminder messages sent by the chatbot to the patient and their family, the researcher will also contact them to inquire about the reason. Furthermore, if interaction is discontinued for more than seven days, it will be regarded as sustained non-engagement, and the participant will be excluded from the study. Intervention 3: Control group: Participants will continue to receive routine care, including all required medical and supportive services, as before, through healthcare centers. After completion of the study, in order to observe ethical considerations, the educational content developed based on the ENABLE model will be provided to them. Yes - There is a plan to make this available What will be shared: Yes - There is a plan to make this available When: The access period is 12 months after the publication of the article To whom: Researchers employed at reputable institutions with a motivation for improvement. Conditions: Provided that their aim is the treatment and improvement of the condition of patients with heart failure. Where to obtain: They should be in contact with the corresponding author at the email address How to obtain: After the process of eligibility researcher and verification, the request recipient's information will be shared with study collaborators, and the publishable data will be made available. Comments:
public seyedmahdi sharifi
Boys' Dormitory of Medical Sciences, Farshchi Moghaddam, North Kargar Street, Tehran, Iran
tehran Iran (Islamic Republic of) 1439955975 +98 86 3222 7550 seyedmahdisharifi80@gmail.com Tehran University of Medical Sciences scientific parvaneh asgari
Dr. Mirkhani Street (East Nusrat), Towhid Square
tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 p-asgari@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) inclusion criteria for patients are as follows:Informed Consent: Providing informed consent to participate in the study.Age: Individuals aged 18 to 65 years.Heart Failure Stage: Stage B or C heart failure, based on the American College of Cardiology/American Heart Association classification system, confirmed by a heart failure specialist physician.Literacy: Ability to read and write in Persian.Technology Access: Access to the internet and ability to use a mobile phone. inclusion criteria for family caregivers are as follows:Informed Consent: Providing informed consent to participate in the study.Age: Individuals over 18 years of age.Literacy: Ability to read and write in Persian.Technology Access: Access to the internet and ability to use a mobile phone. 18 years 65 years Both I50 Heart failure Lifestyle Lifestyle Lifestyle Intervention group: The participants will receive online education, and the intervention will be implemented based on the ENABLE model in an online format. Initially, an in-person session will be held with patients and their family caregivers, during which necessary information will be provided regarding their disease, palliative care, and the structure of the intervention program. Afterwards, a six-week early palliative care program will be delivered through weekly webinars via Google Meet or Skyroom. Each session will last between 45 minutes and one hour. Intervention group: Participants will receive the educational content via a chatbot. The intervention, based on the ENABLE model, will be delivered through an intelligent interactive chatbot. First, an in-person training session will be held for the patient and their family caregiver on how to use the chatbot (installation, login, and interaction). In addition, initial training will be provided on how to use the system, how to ask questions, how to recognize emergency conditions, and an introduction to the applications of the chatbot. A written user guide will also be accessible within the system. The educational content, developed according to the ENABLE model, will be prepared in the form of short text files, simple audio files, infographics, and short videos, and then uploaded to the chatbot’s internal platform. The duration of the intervention will be six weeks, similar to the first group. To assess adherence to chatbot use, engaging with the chatbot less than twice per week for two consecutive weeks will be considered a significant reduction in adherence. In such cases, in addition to reminder messages sent by the chatbot to the patient and their family, the researcher will also contact them to inquire about the reason. Furthermore, if interaction is discontinued for more than seven days, it will be regarded as sustained non-engagement, and the participant will be excluded from the study. Control group: Participants will continue to receive routine care, including all required medical and supportive services, as before, through healthcare centers. After completion of the study, in order to observe ethical considerations, the educational content developed based on the ENABLE model will be provided to them. Patient quality of life. Timepoint: before and after intervention. Method of measurement: Kansas city Questionnaire. Caregiving Outcomes. Timepoint: before and after intervention. Method of measurement: bcos Questionnaire. Functional Assessment of Chronic Illness Therapy. Timepoint: before and after intervention. Method of measurement: FACIT PAL-14 Questionnaire. Patient Readiness to Engage in Health Information Technology. Timepoint: Before and after intervention. Method of measurement: PRE-HIT Questioner. Tehran University of Medical Sciences Approved 2025-09-08 Research Ethics Committee of School of Nursing and midwifery And Rehabilitation- Tehran University 6th floor. Central Headquarters of Tehran University of Medical Sciences, at the corner of Ghods Street, Keshavarz Boulevard tehran Tehran Iran (Islamic Republic of)