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IRCT20260606069667N1 IRCT 2026-06-23 Yazd University of Medical Sciences The effect of the COPE care model on the resilience of Alzheimer's family caregivers Investigating the effectiveness of the supportive-educational program based on the COPE care model on the resilience and care burden of family caregivers of elderly people with Alzheimer's disease 2026-06-22 anticipated 68 Complete https://irct.ir/trial/90970 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be selected by sampling method and after obtaining an informed consent, they will be randomly assigned to two intervention and control groups. Simple random assignment will be used to assign the samples to the two groups. For this purpose, the researcher will first perform randomization using web-based randomization (using the Research Randomizer site) and enter study information, including the number of groups and the number of samples in each group, so that companies will be assigned to the intervention or control group, respectively. Allocation concealment will be done using opaque, sealed, and randomly sequenced envelopes. The goal of this method is that the participant and the researcher do not know the assigned group (test or control) before opening the envelope. In this regard, the supervisor, as a third party and without the researcher's involvement in the allocation process, will place the codes and assigned group in a total of 68 envelopes according to the randomization list prepared in the previous step, and the envelopes will be closed and sealed after entering the information. At the time of allocation, each caregiver receives an envelope and, after opening it, announces the name of their group to the researcher; then, the researcher will register them in the test or control group list according to the allocation result. N/A Alzheimer's disease. Intervention 1: The control group will receive only the routine services provided, which are also provided by the intervention group. These routine services include the center's standard education about the nature of Alzheimer's disease, how to properly take medications, timing and monitoring the patient's symptoms, general advice about patient safety, basic strategies for managing problematic behaviors, and brief, routine consultations from a nurse or physician about daily care. Intervention 2: Intervention group: Type of intervention: Supportive-educational intervention based on the COPE caregiving mode. Caregivers of the test group will participate in a total of five group training sessions (groups of 8-10 people) for 60 to 90 minutes, designed based on the COOP model. These sessions will include three in-person sessions at the Yazd Alzheimer's Association and two virtual sessions on Google Meet. One session will be held each week, which will be completed in a total of 5 weeks of intervention. The timing of these sessions will be determined by agreement between the researcher and the caregivers to ensure that all participants can participate fully in this educational process. The presentation of the material will be through a combination of lecture methods using slides, group discussion, and scenarios. Also, weekly telephone follow-ups (every Thursday between 8:00 AM and 12:00 AM) will be conducted by the researcher for three months. It should be noted that at the end of the first in-person session, the researcher's phone number will be provided to the participants for calling and questioning. Also, at the end of the second in-person session, the participants will receive the necessary training to use the Google Meet platform in virtual meetings. the first session, which focuses on the emotional component and expert information (E), the goal is to provide emotional support and increase awareness about Alzheimer's. ⦁The second session focuses on cognitive skills (C) and aims to strengthen problem-solving abilities and provide creative solutions. ⦁In the third session, which is dedicated to the optimism and mental resilience component (O), caregivers practice cognitive review, positive self-talk, and recording three good things daily. ⦁The fourth session focuses on the planning and practical component (P) and aims to increase caregivers' control over daily activities and reduce caregiving burden. The fifth session is dedicated to integrating all components. In this session, a review of all sessions, questions and answers, and completion of the Personal Care Plan booklet are conducted to consolidate learning and enable caregivers to practically apply all COPE components in daily life. This process ensures that the training is not just theoretical and that caregivers actively and practically improve their skills. Yes - There is a plan to make this available What will be shared: Primary and secondary data, data coding, and study protocol When: Access period starts 6 months after results are published. To whom: Researchers working in academic and scientific institutions People who are also involved in industry Conditions: Participant data will be used solely for secondary analyses, meta-analyses, and related scientific research. Access to data is possible after submitting a written request and a valid scientific proposal, approval by the research team, and a commitment to maintaining confidentiality of information. Where to obtain: By email haniehosseini7810@gmail.com or phone 098 9135564233 How to obtain: The applicant must submit a written request to the principal investigator, including the research objectives, analysis plan, and research team specifications. Requests will be reviewed scientifically and ethically by the research team. If approved, and after signing a confidentiality and data use agreement, access to anonymized data will be provided. Comments:
public Hanie Hosseini
No 26,Resalat 4,Resalat Blvd,Boroujen
Boroujen Iran (Islamic Republic of) 8871643783 +98 38 3422 6653 haniehosseini7810@gmail.com Yazd University of Medical Sciences scientific Hanie Hosseini
No 26,Resalat 4,Resalat Blvd,Boroujen
Boroujen Iran (Islamic Republic of) 8871643783 +98 38 3422 6653 haniehosseini7810@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Written informed consent and willingness Caregiver age over 18 years and under 65 years Ability to read, write, understand, and receive instruction in Persian Designation as primary caregiver based on self-declaration At least three months of continuous caregiving experience for the elderly (on a daily or almost daily basis) 18 years 65 years Both Employment in health professions Concurrent care of another chronic patient Participating in a concurrent study G30.9 Alzheimer's disease, unspecified Other Other The control group will receive only the routine services provided, which are also provided by the intervention group. These routine services include the center's standard education about the nature of Alzheimer's disease, how to properly take medications, timing and monitoring the patient's symptoms, general advice about patient safety, basic strategies for managing problematic behaviors, and brief, routine consultations from a nurse or physician about daily care. Intervention group: Type of intervention: Supportive-educational intervention based on the COPE caregiving mode. Caregivers of the test group will participate in a total of five group training sessions (groups of 8-10 people) for 60 to 90 minutes, designed based on the COOP model. These sessions will include three in-person sessions at the Yazd Alzheimer's Association and two virtual sessions on Google Meet. One session will be held each week, which will be completed in a total of 5 weeks of intervention. The timing of these sessions will be determined by agreement between the researcher and the caregivers to ensure that all participants can participate fully in this educational process. The presentation of the material will be through a combination of lecture methods using slides, group discussion, and scenarios. Also, weekly telephone follow-ups (every Thursday between 8:00 AM and 12:00 AM) will be conducted by the researcher for three months. It should be noted that at the end of the first in-person session, the researcher's phone number will be provided to the participants for calling and questioning. Also, at the end of the second in-person session, the participants will receive the necessary training to use the Google Meet platform in virtual meetings. the first session, which focuses on the emotional component and expert information (E), the goal is to provide emotional support and increase awareness about Alzheimer's. ⦁The second session focuses on cognitive skills (C) and aims to strengthen problem-solving abilities and provide creative solutions. ⦁In the third session, which is dedicated to the optimism and mental resilience component (O), caregivers practice cognitive review, positive self-talk, and recording three good things daily. ⦁The fourth session focuses on the planning and practical component (P) and aims to increase caregivers' control over daily activities and reduce caregiving burden. The fifth session is dedicated to integrating all components. In this session, a review of all sessions, questions and answers, and completion of the Personal Care Plan booklet are conducted to consolidate learning and enable caregivers to practically apply all COPE components in daily life. This process ensures that the training is not just theoretical and that caregivers actively and practically improve their skills. Primary outcome: Care burden score of family caregivers of elderly people with Alzheimer's disease, measured using the Zarit Care Burden Questionnaire. Measurement times: before the intervention, immediately after the intervention, and three months after the intervention. Timepoint: At the beginning of the study, immediately after the intervention, and three months after the intervention. Method of measurement: Zarit Caregiver Burden Questionnaire. Resilience score of family caregivers of elderly people with Alzheimer's disease measured using the Connor and Davidson Resilience Questionnaire. Timepoint: At the beginning of the study, immediately after the intervention, and three months after the intervention. Method of measurement: Connor-Davidson Resilience Scale (CD-RISC). Yazd University of Medical Sciences Approved 2026-02-16 Ethics committee of shahid sadoughi university of Medical sciences NO26، Resalat 4 Ave، Resalat Blvd ، Boroujen City Yazd Yazd Iran (Islamic Republic of)