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IRCT20261024071545N1 IRCT 2026-10-28 Tehran University of Medical Sciences Effect of an AI-Augmented Home-Based Palliative Care Education Program on Functional Status and Quality of Life in Stroke Survivors and Their Family Caregivers Effect of an AI-Augmented Home-Based Palliative Care Education Program on Functional Status and Quality of Life in Stroke Survivors and Their Family Caregivers 2026-12-21 anticipated 90 Pending https://irct.ir/trial/94311 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be randomly allocated to three groups (two intervention groups and one control group) using block randomization with replacement. Blocks of six will be used, with the first intervention group designated as Group A, the second intervention group as Group B, and the control group as Group C. All possible allocation sequences will be written on separate cards, and each card will be assigned a number. The numbers will then be written on separate slips of paper and randomly drawn until the target sample size is reached. Allocation concealment will be ensured using sealed envelopes. Each envelope will contain the letter corresponding to the assigned group according to the predetermined allocation sequence. The envelopes will be sealed by a research team member and provided to the researcher. N/A Ischemic Stroke. Intervention 1: Intervention group 1: The home-based palliative care education program will be delivered individually by the researcher to patients and their family caregivers through six face-to-face sessions over one month. In parallel, family caregivers will have smartphone access to an artificial intelligence-based educational chatbot developed using ChatGPT (OpenAI) and Custom GPT, powered by GPT-5.5 or the latest stable model available at the time of the study. The chatbot will serve as an educational assistant to reinforce face-to-face education and answer questions related to the study-approved educational content, including skin care, mobility exercises, and nutrition. It will not provide independent treatment recommendations or prescribe medications. Before the intervention, caregivers will receive training on how to use the chatbot and understand its limitations. The chatbot’s responses will be assessed for accuracy before implementation, and a sample of conversations will be reviewed weekly throughout the study. Usage frequency, number of questions, and interaction duration will be recorded as indicators of adherence to the intervention. Caregivers will be instructed not to enter identifiable patient information into the chatbot. The educational materials will be developed based on scientific literature and clinical guidelines and reviewed by experts and family caregivers for content validity, clarity, and comprehensibility. Intervention 2: Intervention group 2: Participants will receive the same home-based palliative care education program, with identical educational content and six face-to-face sessions delivered by the researcher over one month, without the use of any artificial intelligence tools. Intervention 3: Control group: Participants will receive usual post-discharge care and education throughout the study period. After data collection is completed, the home-based palliative care educational materials will be provided to the control group as an educational package for ethical reasons. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after anonymizing individuals. When: The access period will begin 12 months after the publication of the results. To whom: The data will not only be available to researchers working at academic and scientific institutions, but individuals employed in industry can also apply to access them. Conditions: No other specific condition is required. 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 Mobina Momeni Daraby
Dr. Mirkhani Street (East Nusrat), Towhid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 m-momenid@razi.tums.ac.ir 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: Age 18 years or older. Inclusion criteria for patients: Confirmed diagnosis of ischemic stroke by a neurologist based on clinical findings and imaging. Inclusion criteria for patients: No coexisting disabling chronic diseases that may affect functional status or quality of life, such as dementia, multiple sclerosis, or chronic kidney disease. Inclusion criteria for patients: Discharge from an acute-care hospital to home. Inclusion criteria for patients: National Institutes of Health Stroke Scale (NIHSS) score of 5–20. Inclusion criteria for patients: Not receiving invasive mechanical ventilation Inclusion criteria for family caregivers: An unpaid family member who is the patient's primary caregiver and provides most of their daily care. Inclusion criteria for family caregivers: First-time experience in caring for a patient with ischemic stroke. Inclusion criteria for family caregivers: Ability to read and write in Persian. Inclusion criteria for family caregivers: No self-reported history of mental illness. Inclusion criteria for family caregivers: Not being a member of the healthcare team. Inclusion criteria for family caregivers: No uncorrected visual or hearing impairments. Inclusion criteria for family caregivers: Access to the internet and ability to use a smartphone. 18 years no limit Both Unwillingness to continue cooperation Occurrence of an acute medical condition or hospital readmission. Death of the patient during the study, or permanent transfer of the patient to a care facility, resulting in the termination of the family caregiver's role. Change in the patient's primary caregiver during the study. Receipt of dedicated home nursing or physiotherapy services outside usual care during the study Failure to use the AI chatbot for one week in the AI intervention group Previous or concurrent participation in another similar educational program. Loss to follow-up due to inability to contact the participant. Incomplete questionnaires, defined as completion of fewer than 70% of the questionnaire items. I63 Cerebral infarction Lifestyle Lifestyle N/A Intervention group 1: The home-based palliative care education program will be delivered individually by the researcher to patients and their family caregivers through six face-to-face sessions over one month. In parallel, family caregivers will have smartphone access to an artificial intelligence-based educational chatbot developed using ChatGPT (OpenAI) and Custom GPT, powered by GPT-5.5 or the latest stable model available at the time of the study. The chatbot will serve as an educational assistant to reinforce face-to-face education and answer questions related to the study-approved educational content, including skin care, mobility exercises, and nutrition. It will not provide independent treatment recommendations or prescribe medications. Before the intervention, caregivers will receive training on how to use the chatbot and understand its limitations. The chatbot’s responses will be assessed for accuracy before implementation, and a sample of conversations will be reviewed weekly throughout the study. Usage frequency, number of questions, and interaction duration will be recorded as indicators of adherence to the intervention. Caregivers will be instructed not to enter identifiable patient information into the chatbot. The educational materials will be developed based on scientific literature and clinical guidelines and reviewed by experts and family caregivers for content validity, clarity, and comprehensibility. Intervention group 2: Participants will receive the same home-based palliative care education program, with identical educational content and six face-to-face sessions delivered by the researcher over one month, without the use of any artificial intelligence tools. Control group: Participants will receive usual post-discharge care and education throughout the study period. After data collection is completed, the home-based palliative care educational materials will be provided to the control group as an educational package for ethical reasons. Patient quality of life. Timepoint: Before the intervention and after completion of the one-month intervention. Method of measurement: Stroke-Specific Quality of Life Proxy (SS-QOL Proxy). Functional status of patient. Timepoint: Before the intervention and after completion of the one-month intervention. Method of measurement: Barthel Index. Quality of life of family caregiver. Timepoint: Before the intervention and after completion of the one-month intervention. Method of measurement: Adult Carer Quality of Life Questionnaire (AC-QoL). Tehran University of Medical Sciences Approved 2026-10-20 Research Ethics Committee of School of Nursing and midwifery -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)