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IRCT20250902067101N1 IRCT 2025-12-06 Tabriz University of Medical Sciences The effect of a Care Program Based on Pender's Health Promotion Model on the Caregiver Burden of Family Caregivers The effect of a Care Program Based on Pender's Health Promotion Model on the Caregiver Burden of Family Caregivers of patients with Alzheimer's Disease 2025-12-22 anticipated 120 Complete https://irct.ir/trial/85966 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A total of 120 participants meeting the inclusion criteria will be recruited for the study. A blocked randomization sequence (block size = 6, allocation ratio 1:1) will be generated using SPSS version 27 by one of the authors who is blinded to the study hypothesis and the intervention assignment. The allocation sequence will be placed in sequentially numbered, opaque, sealed envelopes and concealed until the initiation of the intervention, Blinding description: The outcome assessor and the data analyst will be blinded to participants’ group allocation to minimize detection and analysis bias. Due to the nature of the intervention (educational program), blinding of participants and the primary investigator will not be feasible. 3 caregiver burden of patients with Alzheimer's Disease. Intervention 1: Intervention group: After completing the demographic questionnaire and the Caregiver Burden Inventory (CBI), participants in the intervention group will be divided into six subgroups of ten individuals each for group-based sessions. The caregiving program, based on Pender’s Health Promotion Model, will be delivered by one of the researchers in six 45–60-minute sessions.In the first session, following an initial assessment, the researcher, with the assistance of the patient’s caregiver, will review the goals that the caregiver needs to achieve and determine the desired outcomes for each participant. The content of the sessions will be as follows:Session 1: Introduction to the program, education on the concept of caregiver burden, and mental health.Session 2: Introduction to Pender’s Health Promotion Model and its application in caregiving.Session 3: Stress management and coping strategies for caregiver fatigue.Session 4: Training in effective communication techniques with the patient.Session 5: Time management and planning for caregiving tasks.Session 6: Review and summary of the topics, provision of supplementary resources, and addressing participants’ questions. Intervention 2: Control group: Caregivers of patients with Alzheimer’s disease who meet the inclusion criteria will not receive the caregiving program based on Pender’s Health Promotion Model. If the intervention proves to be effective, the educational materials will be made available to this group in the form of a booklet. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations and confidentiality concerns regarding patient caregivers, there is no plan to share deidentified IPD from this study.
public Reza Nematollahi Maleki
Azadi boulevard, Azadi dormitory
Tabriz Iran (Islamic Republic of) 5163958156 +98 914 561 8507 r.nematollahi@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Reza Nematollahi Maleki
Azadi boulevard
Tabriz Iran (Islamic Republic of) 5163958156 +98 914 561 8507 r.nematollahi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Aged between 18-65 Being literate Being the primary caregiver of the patient Having taken care of the patient for at least 6 months Being the first degree relative 18 years 65 years Both The patient under care has another illness besides Alzheimer's disease, such as cancer and cardiovascular diseases. G30 Alzheimer's disease Behavior N/A Intervention group: After completing the demographic questionnaire and the Caregiver Burden Inventory (CBI), participants in the intervention group will be divided into six subgroups of ten individuals each for group-based sessions. The caregiving program, based on Pender’s Health Promotion Model, will be delivered by one of the researchers in six 45–60-minute sessions.In the first session, following an initial assessment, the researcher, with the assistance of the patient’s caregiver, will review the goals that the caregiver needs to achieve and determine the desired outcomes for each participant. The content of the sessions will be as follows:Session 1: Introduction to the program, education on the concept of caregiver burden, and mental health.Session 2: Introduction to Pender’s Health Promotion Model and its application in caregiving.Session 3: Stress management and coping strategies for caregiver fatigue.Session 4: Training in effective communication techniques with the patient.Session 5: Time management and planning for caregiving tasks.Session 6: Review and summary of the topics, provision of supplementary resources, and addressing participants’ questions. Control group: Caregivers of patients with Alzheimer’s disease who meet the inclusion criteria will not receive the caregiving program based on Pender’s Health Promotion Model. If the intervention proves to be effective, the educational materials will be made available to this group in the form of a booklet. Caregiver burden. Timepoint: The caregiver burden of family caregivers will be assessed at two time points: once before the intervention (baseline) and once two months after the final educational session (follow-up). Method of measurement: Measurement will be conducted using the Caregiver Burden Inventory (CBI), administered by a trained assessor either in person or via telephone. Tabriz University of Medical Sciences Approved 2025-06-02 Research Ethics Committees of Tabriz University of Medical Sciences Azadi boulevard Tabriz East Azarbaijan Iran (Islamic Republic of)