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IRCT20190303042900N7 IRCT 2026-07-29 Shahre-kord University of Medical Sciences Effect of Family-Centered Empowerment on family function and caregiver burden in family caregivers of patients with chronic heart failure Comparison of the effect of the Family-Centered Empowerment Model with routine care on family function and caregiver burden in family caregivers of patients with chronic heart failure 2026-08-01 anticipated 64 Recruiting https://irct.ir/trial/91122 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: There are no other design features, Randomization description: In this study, the unit of randomization will be each eligible family caregiver. After assessing the inclusion and exclusion criteria and obtaining written informed consent, family caregivers will be randomly allocated to one of two study groups: the intervention group receiving the family-centered empowerment model and the control group receiving routine care. Randomization will be performed using permuted block randomization with a fixed block size of four. To cover the total sample size of 64 participants, 16 blocks will be generated. In each block, two participants will be allocated to the intervention group and two participants to the control group, ensuring balanced group sizes throughout the recruitment process. The random allocation sequence will be generated before the start of recruitment by an independent person who is not involved in participant enrollment, using statistical software or Random Allocation Software. Allocation concealment will be maintained by keeping the randomization sequence unavailable to the researcher responsible for recruitment. Allocation will be implemented using sequentially numbered, opaque, sealed envelopes. Each envelope will be opened only after the participant has been definitively enrolled in the study and written informed consent has been obtained. N/A Chronic heart failure. Intervention 1: Intervention group: Family caregivers in the intervention group will receive a program based on the Family-Centered Empowerment Model. The program will be delivered in 8 group sessions, two sessions per week, each lasting 60 to 90 minutes. The sessions will include perceived threat, improvement of self-efficacy and problem-solving, educational participation, and evaluation. The sessions will be held for small groups of family caregivers, and the educational content will be tailored to the caregiving needs of patients with chronic heart failure. Intervention 2: Control group: Family caregivers in the control group will receive routine care provided in the clinical setting. No additional educational intervention based on the Family-Centered Empowerment Model will be provided during the study period. Yes - There is a plan to make this available What will be shared: The deidentified individual participant data will include demographic characteristics of family caregivers, baseline caregiving-related information, Zarit Burden Interview scores, and McMaster Family Assessment Device scores measured before the intervention, immediately after the intervention, and three months after the intervention. The final study protocol, informed consent form, clinical study report, statistical analytic codes, and data dictionary will also be shared. All identifying information will be removed before data sharing. When: The deidentified data and supporting documents will become available after publication of the main study results and will remain available for 3 years after publication of the main results. To whom: The deidentified data and supporting documents will be available to qualified researchers affiliated with universities, academic institutions, or research organizations who submit a valid and methodologically sound research proposal. Requests from researchers in other sectors will also be considered if the proposed research is consistent with the study objectives and ethical research principles. Conditions: Access to the data and documents will be granted only for research purposes consistent with the objectives of the original study and in accordance with ethical and confidentiality principles. Applicants must submit a research proposal including the study objective, methodology, analysis plan, and intended use of the data. Requests will be reviewed by the responsible investigator and research team. If approved, the applicant will be required to sign a data use and confidentiality agreement. Use of the data for participant identification or unrelated purposes will not be permitted. Where to obtain: Applicants can request access to the deidentified data and supporting documents by sending an email to the responsible investigator at sh.salehitali@skums.ac.ir. The request should include a research proposal, the intended purpose of data use, the analysis plan, and the applicant’s contact information. Additional communication can be made by telephone at +98 38 3224 0556 if needed. How to obtain: The applicant must submit a formal request and research proposal by email. After receiving the request, the research team will review it for scientific validity, consistency with the study objectives, feasibility of the proposed analysis, and compliance with ethical and confidentiality principles. The review process will usually take up to 4 weeks. If the request is approved, the applicant will be required to sign a data use agreement, and the approved data and documents will then be provided through a secure transfer method. Comments: All data sharing procedures will be conducted in accordance with research ethics principles, confidentiality requirements, and removal of participants’ identifying information.
public Shahriar Salehi Tali
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Kashani Boulevard, Shahrekord, Iran
shahrekord Iran (Islamic Republic of) 8817846935 +98 38 3334 1215 sh.salehitali@skums.ac.ir Shahre-kord University of Medical Sciences scientific Shahriar Salehi Tali
Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences, Kashani Boulevard, Shahrekord, Iran
shahrekord Iran (Islamic Republic of) 8817846935 +98 38 3334 1215 sh.salehitali@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Being the primary family caregiver of a patient with chronic heart failure classified as NYHA functional class III or IV. Family caregivers aged 18 years and older.Having at least 6 months of caregiving experience for the patient. Providing the main part of care for the patient by the family caregiver. Having the ability to read and write. Providing written informed consent to participate in the study. 18 years no limit Both Having a known psychiatric disorder or a history of psychiatric disorder based on medical records or caregiver self-report. Concurrent participation of the family caregiver in another research study at the time of enrollment. Having severe physical, cognitive, hearing, or speech impairment that prevents participation in empowerment sessions or completion of questionnaires. Inability of the family caregiver to attend the empowerment program sessions at the time of enrollment. I50 Heart failure Behavior Behavior Intervention group: Family caregivers in the intervention group will receive a program based on the Family-Centered Empowerment Model. The program will be delivered in 8 group sessions, two sessions per week, each lasting 60 to 90 minutes. The sessions will include perceived threat, improvement of self-efficacy and problem-solving, educational participation, and evaluation. The sessions will be held for small groups of family caregivers, and the educational content will be tailored to the caregiving needs of patients with chronic heart failure Control group: Family caregivers in the control group will receive routine care provided in the clinical setting. No additional educational intervention based on the Family-Centered Empowerment Model will be provided during the study period. The mean caregiver burden score among family caregivers of patients with chronic heart failure. Timepoint: Before the intervention, immediately after the intervention, and three months after the intervention. Method of measurement: Caregiver burden will be measured using the Zarit Burden Interview questionnaire. This questionnaire consists of 22 items, and higher scores indicate a greater caregiver burden. The mean family functioning score among family caregivers of patients with chronic heart failure. Timepoint: Before the intervention, immediately after the intervention, and three months after the intervention. Method of measurement: Family functioning will be measured using the McMaster Family Assessment Device questionnaire. This questionnaire evaluates different dimensions of family functioning, and higher scores indicate poorer family functioning. Shahre-kord University of Medical Sciences Approved 2026-05-18 Ethics Committee of Shahrekord University of Medical Sciences Shahrekord University of Medical Sciences, Kashani Boulevard Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)