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IRCT20251211068284N1 IRCT 2026-02-23 Babol University of Medical Sciences Investigating the effect of a remote empowerment training program on stress, caregiving burden, self-efficacy, and caregiving experience in family caregivers of people with Alzheimer's disease Investigating the effect of a remote empowerment training program on stress, caregiving burden, self-efficacy, and caregiving experience in family caregivers of Alzheimer's patients, based on the caregiving stress process model 2026-02-24 anticipated 120 Recruiting https://irct.ir/trial/88187 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization will be used to balance the size of the groups. Stratified randomization based on important variables (e.g., caregiver age, duration of care, patient severity) will be used to reduce bias. Randomization will be performed using Excel software and allocation concealment will be provided via sealed envelopes, Blinding description: The study is designed as a double-blind study. The participants are unaware of the characteristics of the groups. The researcher is aware of the grouping and implements the intervention. A statistician who is separate from the study process and unaware of all the procedures performed will be used to analyze the data. N/A Family caregivers with Alzheimer's disease. Intervention 1: Intervention group: Intervention group: Intervention group: Remote empowerment training program based on the Caregiver Stress Process Model (SPM) that is implemented for 4 weeks. The training content includes 8 sessions (two sessions per week) in the form of audio podcasts, educational videos, etc. 30 to 40 minutes long along with a visual summary file of key points (JPEG or PDF) are sent to participants via WhatsApp messenger. The session titles are: 1. Introduction to Alzheimer's and the role of caregivers, 2. Identification of primary stress factors, 3. Identification of secondary stress factors, 4. Perceived stress and caregiver emotions, 5. Psychological coping strategies, 6. Social support and available resources, 7. Promoting a sense of self-efficacy, 8. Review, summarization, and planning for the future. In addition to the training content, participants join a WhatsApp support group and receive a weekly follow-up phone call from the researcher to ensure receipt of the content, answer questions, and encourage participation. Reminder and motivational SMS messages are also sent twice a week. Weekly exercises are also sent and followed by participants via a Pressline link or a WhatsApp group link. Intervention 2: Control group: Control group: Participants in this group do not receive any specific educational intervention from the researcher and only receive routine care, which includes common services in the comprehensive health centers under their coverage (such as doctor visits, regular counseling sessions, distribution of general brochures, and common support services). These individuals will be placed on a waiting list to receive the educational program, and after completing the study and following up, if desired, all the educational content of the empowerment program will be made available to them. Participants in the control group will complete research questionnaires at the same time points as the intervention group (pre-test, post-test immediately after 4 weeks, and one-month follow-up). 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 Bakhtiari Afshane
Ganjafroz Street, Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4717647745 +98 911 311 6889 afbakhtiari@gmail.com Babol University of Medical Sciences scientific Bakhtiari Afsaneh
Ganjafroz Street, Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4717647745 +98 911 311 6889 afbakhtiari@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Primary caregiver of a patient with Alzheimer's disease(not a substitute or temporary caregiver) Informal caregiver(family caregiver) At least 6 months of caregiving experience (at least 20 hours per week) Age 18 to 70 years Ability to use a smartphone or computer and access the Internet Literacy Willingness and informed consent to participate in the study 18 years 70 years Both Having a physical disorder, severe psychiatric disorder, or chronic debilitating illness Discontinuation of caregiving relationship with the elderly person during the study (e.g., death of the elderly person or abandonment of care) Participation in a similar educational program in the last 6 months Withdrawal from further cooperation at any stage of the study Lack of active cooperation in digital empowerment programs Occurrence of critical incidents Behavior Behavior Intervention group: Intervention group: Intervention group: Remote empowerment training program based on the Caregiver Stress Process Model (SPM) that is implemented for 4 weeks. The training content includes 8 sessions (two sessions per week) in the form of audio podcasts, educational videos, etc. 30 to 40 minutes long along with a visual summary file of key points (JPEG or PDF) are sent to participants via WhatsApp messenger. The session titles are: 1. Introduction to Alzheimer's and the role of caregivers, 2. Identification of primary stress factors, 3. Identification of secondary stress factors, 4. Perceived stress and caregiver emotions, 5. Psychological coping strategies, 6. Social support and available resources, 7. Promoting a sense of self-efficacy, 8. Review, summarization, and planning for the future. In addition to the training content, participants join a WhatsApp support group and receive a weekly follow-up phone call from the researcher to ensure receipt of the content, answer questions, and encourage participation. Reminder and motivational SMS messages are also sent twice a week. Weekly exercises are also sent and followed by participants via a Pressline link or a WhatsApp group link. Control group: Control group: Participants in this group do not receive any specific educational intervention from the researcher and only receive routine care, which includes common services in the comprehensive health centers under their coverage (such as doctor visits, regular counseling sessions, distribution of general brochures, and common support services). These individuals will be placed on a waiting list to receive the educational program, and after completing the study and following up, if desired, all the educational content of the empowerment program will be made available to them. Participants in the control group will complete research questionnaires at the same time points as the intervention group (pre-test, post-test immediately after 4 weeks, and one-month follow-up). Caregiving burden. Timepoint: At the beginning of the study (before the start of the intervention), at the end of the training sessions (end of the intervention), and 1 month after the last training session. Method of measurement: Zarit Burden Interview. Perceived stress. Timepoint: At the beginning of the study (before the start of the intervention), at the end of the training sessions (end of the intervention), and 1 month after the last counseling session. Method of measurement: Perceived Stress Scale. Self-efficacy. Timepoint: At the beginning of the study (before the start of the intervention), at the end of the training sessions (end of the intervention), and 1 month after the last counseling session. Method of measurement: Caregiver Self-Efficacy Scale. Care experience. Timepoint: At the beginning of the study (before the start of the intervention), at the end of the training sessions (end of the intervention), and 1 month after the last counseling session. Method of measurement: Revised Care Experience Assessment Scale. Babol University of Medical Sciences Approved 2025-12-08 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafroz Street Babol Mazandaran Iran (Islamic Republic of)