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

To determine the effect of the Family-Centered Empowerment Model compared with routine care on family function and caregiver burden among family caregivers of patients with chronic heart failure.

This is an interventional, two-arm, randomized, controlled, parallel-group clinical trial, conducted on 64 family caregivers. Allocation will be performed using permuted block randomization.

The study will be conducted in Hajar and Kashani hospitals and Imam Ali Clinic affiliated with Shahrekord University of Medical Sciences. Eligible caregivers will be allocated after informed consent. Data will be collected before, immediately after, and three months after the intervention. The statistical analyst will be blinded to group codes.

Primary family caregivers of patients with chronic heart failure classified as NYHA class III or IV will be included. Main inclusion criteria are age 18 years or older, at least 6 months of caregiving experience, ability to read and write, and informed consent. Main exclusion criteria are known psychiatric disorder, concurrent participation in another study, severe impairment preventing session attendance or questionnaire completion, and inability to attend sessions.

The intervention group will receive the Family-Centered Empowerment Model in 8 group sessions, two sessions per week, each lasting 60 to 90 minutes. The control group will receive routine care and education, and the educational package will be provided after study completion.

Family function score measured by McMaster Family Assessment Device; caregiver burden score measured by Zarit Burden Interview, before, immediately after, and three months after the intervention

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.

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.

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.

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.

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.

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.

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.

All data sharing procedures will be conducted in accordance with research ethics principles, confidentiality requirements, and removal of participants’ identifying information.